The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients: a Mechanistic Study of Art Therapy in Reducing Depression, Fatigue and Pain.
Phase: NA
Conditions: Breast Cancer Female, Depressive Symptoms, Fatigue, Pain, Emotions, Inflammation
Sponsor: University of Haifa

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Clinical Protocol 
 
REPAT- Role of Emotional Processing in Art Therapy for Breast 
Cancer Palliative Care Patients:  
A Mechanistic Study 
Principal Investigators: 
Dr. Johanna Czamanski Cohen, PhD; Assistant Professor, 
University of Haifa 
Dr. Karen Weihs, MD, Professor of Psychiatry & Family Medicine, 
University of Arizona 
Tool Revision History 
Version Number: 2 
Version Date:  June 25th, 2017 
Summary of Revisions Made: 
Version Number:1 
Version Date: September 16th, 2016 
Summary of Revisions Made: 
Version Number:  3 
Version Date: September 17th, 2018 
Summary of Revisions Made: Changes to time points and clarification of fidelity checks 
Version Number: 4 
Version Date: October 14th, 2018 
Summary of Revisions Made: 
4

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TABLE OF CONTENTS 
   Page 
Tool Revision History ............................................................................................................. 1 
TABLE OF CONTENTS ............................................................................................................ 2 
STUDY TEAM ROSTER ........................................................................................................ 4 
PARTICIPATING STUDY SITES ........................................................................................... 6 
1. STUDY OBJECTIVES ........................................................................................................... 9 
2. BACKGROUND AND RATIONALE....................................................................................... 9 
2.1 Background on Condition, Disease, or Other Primary Study Focus .................................. 9 
3. STUDY DESIGN ...................................................................................................................12 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ......................................................13 
4.1      Inclusion Criteria .........................................................................................................13 
5. STUDY INTERVENTIONS ....................................................................................................15 
5.1 
Interventions, Administration, and Duration ...............................................................15 
5.2 
Handling of Study Interventions .................................................................................15 
5.3 
Concomitant Interventions .........................................................................................17 
5.3.1 
Allowed Interventions .........................................................................................17 
5.3.2 
Prohibited Interventions .....................................................................................18 
6. STUDY PROCEDURES ........................................................................................................19 
6.1 
Schedule of Evaluations ............................................................................................19 
6.2 
Description of Evaluations .........................................................................................19 
6.2.1 
Screening Evaluation .........................................................................................19 
6.2.2 
Enrollment, Baseline, and/or Randomization ......................................................20 
6.2.3 
Blinding ..............................................................................................................22 
6.2.4 
Follow up Visits- Mid intervention .......................................................................22 
7. SAFETY ASSESSMENTS ....................................................................................................23 
7.1 
Specification of Safety Parameters ............................................................................23 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ....23 
7.3 
Adverse Events and Serious Adverse Events ............................................................23 
7.4       Reporting Procedures ................................................................................................24 
7.5 
Safety Monitoring .......................................................................................................24 
8. 
General Design Issues ................................................................................................24 
   8.1      General Design Issues …………………………………………………………………….24 
   8.2         Sample Size and Randomization ..............................................................................25 
   8.3         Treatment Assignment Procedures. .........................................................................25 
9. DATA COLLECTION AND QUALITY ASSURANCE ...........................................................26 
9.1 
Data Collection Forms ...............................................................................................26 
9.2 
Data Management .....................................................................................................27 
9.3 
Quality Assurance .....................................................................................................27 
9.3.1 
Training ..............................................................................................................27 
9.3.2 
Data and Safety Monitoring Board/ Quality Control Committee ..........................28 
9.3.3 
Monitoring ..........................................................................................................28 
10. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................31 
10.1 
Institutional Review Board (IRB) Review ....................................................................31 

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10.2 
Informed Consent Forms ...........................................................................................32 
10.3 
Participant Confidentiality ..........................................................................................32 
10.4 
Study Discontinuation ................................................................................................32 
11. REFERENCES ...................................................................................................................33 
15. SUPPLEMENTS/APPENDICES .........................................................................................37 
I. Procedures Schedule 
II. Informed Consent Form Template 
III. Questionnaires  

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STUDY TEAM ROSTER  
1. 
Johanna Czamanski-Cohen, PhD 
Email: joczamanski@gmail.com 
Ph:  04-824-9750 
Lab:04-828-8828 
Mobile:053-277-5350 
FAX: 04-828-8685 
Snail Mail: Graduate School of Creative Arts Therapies 
The Prof. Hecht’s Art Building, floor -1 room 27 
University of Haifa 
199 Aba Khoushy Ave. 
Mount Carmel, Haifa 3498838, Israel 
2. 
Karen Weihs, MD  
Email: weihs@email.arizona.edu 
Ph:   520-626-8940 
Fax: 520-626-6050 
Snail Mail: Department of Psychiatry  
College of Medicine  
University of Arizona 
1501 N Campbell Ave. 
Tucson, AZ  85724 
3. 
John JB Allen, PhD  
Email: jallen@email.arizona.edu 
Ph: (520)621-7448 
FAX:(520)621-9306 
Snail Mail: 424 Psychology 
University of Arizona 
Tucson, AZ 85721 
4.      Joshua F. Wiley, PhD 
Email: joshua.wiley@monash.edu  
Ph: +61 3 990 59598 
Mobile: +61 42 4646 114 
Snail Mail: Monash Institute of Cognitive and Clinical Neurosciences  
School of Psychological Sciences 

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Monash University 
18 Innovation Walk Room 510 
Clayton Campus, Clayton VIC 3800 Australia 
5.        Miri Cohen, PhD 
  Email: mcohen2@univ.haifa.ac.il 
  Ph: (04) 8249565 
  Snail Mail: Eshcol Building 5th Floor 
  University of Haifa 
  199 Aba Khoushy Ave. 
  Mount Carmel, Haifa 3498838, Israel 
6. 
  Faisal Azaiza, PhD 
  Email: azaiza@univ.haifa.ac.il 
  Ph: 972-4-8249950 
  Fax: 972-4-8249946 
  Snail Mail: Eshcol Building 7th Floor 
  University of Haifa 
  199 Aba Khoushy Ave. 
  Mount Carmel, Haifa 3498838, Israel 
7. 
  David Faraggi, PhD 
  Email: dfaraggi@univ.haifa.ac.il 
  Ph: 972-4- 8249142 
  Snail Mail: Rabin Building 7th Floor 
  University of Haifa 
  199 Aba Khoushy Ave. 
  Mount Carmel, Haifa 3498838, Israel 
8.       Richard Lane, MD PhD  
  Professor of Psychiatry, Psychology and Neuroscience 
  Ph:  520-626-3272 
  Fax: 520-626-6050 
  Snail mail: 7306C AHSC  
  University of Arizona  
  Tucson, AZ 85724-5002 
 
 

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PARTICIPATING STUDY SITES 
1. 
Rambam Medical Center  
Dr. Georgetta Fried 
Email: g_fried@rambam.health.gov.il  
Ph: 04-7776422 
 
Fax: 04-7773733 
 
Snail Mail: 8 HaAliya HaShniya St. 
  
Haifa, Israel 3109601 
 
 
2. 
Rabin Medical Center 
Prof. Opher Caspi 
Email: Oferc@clalit.org.il 
Ph: 03-9377995 
Fax: 03-9377974 
Snail Mail: Beilinson Hospital,  
Davidoff Cancer Center, Floor -1 
Petach Tikvah, Israel 49100 
 
3. 
Ziv Medical Center 
Prof Jamal Zidan 
Email: Zidan.j@ziv.health.gov.il  
Ph: 04-6828651, 04-5828550  
Fax: 04-6828621 
Oncology Institute 
Derech HaRambam 
Safed, Israel13100 

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Study Title  
REPAT- Role of Emotional Processing in Art Therapy for Breast Cancer Palliative Care Patients: 
A Mechanistic Study 
Objectives  
The purpose of this study is to examine two mechanistic changes: emotion processing 
(awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and 
cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain 
and fatigue. 
Design and Outcomes   
For this means, we have designed a randomized controlled study with careful controls. Our study 
population is comprised of 240 BC patients in palliative and curative care (comprised of 50% 
Jewish and 50% Arab). This population will be randomized (using a permuted block design to 
account for ethnicity and level of traditionalism) to receive a standard art therapy intervention or 
a comparison group. The intervention is designed to increase emotion processing via art making 
in a supportive environment. The sham Art Therapy comparison group will engage in the coloring 
of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping 
with BC, identical to the topics of the AT group. This design will allow the study to test the 
mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement 
with art materials. 
Interventions and Duration  
The AT intervention is an 8-week group intervention comprised of 8 1.5-hour weekly sessions 
conducted by an experienced Art Therapist who received special training in conducting the 
treatment protocol as designed. The intervention and comparison group were piloted on BC 
patients at Beilinson hospital and the protocol was modified based on feedback from the 
participants. Each intervention module is described below. 
The comparison group will be an 8-week group intervention comprised of 8 1-hour weekly 
mandala coloring sessions with a self-care educational component, conducted by someone with 
experience conducting groups who will be trained in providing a well-planned comparison group, 
with fidelity checks that includes coloring pre-fabricated mandalas.  
There will be an additional follow up time point 8 weeks after the intervention is over to assess 

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the lasting effects of the intervention.  
Sample Size and Population  
240 BC survivors will be randomized to the intervention and comparison groups. We are targeting 
300 women and expect an attrition rate of 15%. We also will be targeting the recruit of 50% of our 
sample to be of Arab origin and 50% Jewish.  

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1. STUDY OBJECTIVES 
 
To examine two mechanisms: 1) emotional processing (awareness, acceptance and expression) 
and 2) cholinergic anti-inflammatory processes (resting HRV and inflammatory cytokines), 
through which AT reduces depression, pain and fatigue in Arab and Jewish BC survivors.  
To examine ethno-cultural differences in the effect of Art Therapy in women from a traditional 
collectivist ethno-cultural background, in comparison to women from a more individualist western 
ethno-cultural background.  
2. BACKGROUND AND RATIONALE 
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Over 200,000 women are diagnosed with breast cancer (BC) in the United States annually1. As 
of January 1, 2016 there were 3,560,570 breast cancer survivors in the United States 2. Cancer 
survivorship is defined as living with the challenges that occur as the result of a cancer diagnosis 
and treatment 3. Thus, in this document patient and survivor are used interchangeably. 
Many breast cancer patients cope with depression. Stress and negative emotion are 
normative responses to cancer diagnosis and treatment, but approximately one-third of 
individuals coping with cancer experience the debilitating consequence of depressive disorders4 
which have been linked with functional limitation in survivorship5. Depressive symptoms are 
persistently elevated in the year following cancer diagnosis; 38% of BC survivors experience 
depressive symptoms in the clinical range6,7. These individuals suffer more physical symptoms, 
problems with treatment adherence, functional limitation in survivorship6 and increased mortality8.  
There are several physical symptoms that occur commonly in BC survivors. Pain and 
fatigue are some of the most prominent symptoms that affect quality of life (QoL) and well-being 
of cancer survivors. A reported 25% to 60% of women develop chronic pain after BC treatment 
and chronic fatigue is reported in between 30-60% of survivors3,8,9. Physical symptoms co-
occur with distress and are very difficult to treat. Cancer survivors with high symptom burden 
suffer from diminished QoL, which compromises physical, psychological and social functioning6.  
2.2 Emotion processing has been associated with improved physical and psychological 
health in BC survivors. Emotion processing is comprised of 1) emotional awareness, 2) 
expression, and 3) acceptance. Increased emotional awareness occurs when knowledge is 
transferred from sensorimotor or bodily information to patterns of explicit thought that include 
conscious processing through language or other symbolic formations, such as visual art10-12. Low 
levels of emotion awareness were found in individuals with somatoform disorders13.   Emotional 

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expression refers to the extent to which feelings are intentionally14 (mainly verbally) and non-
intentionally15 (body language, facial expressions) conveyed to others. Increased emotion 
expression and reduced avoidance have long been associated with improved wellbeing16-19. 
Increased emotional expression is associated with improved psychological and physical 
adjustment to BC20-23. Acceptance of emotion is an emotion regulation strategy in which 
individuals embrace an attitude of being accepting, friendly, and nurturing toward their 
feelings19,24. Acceptance of emotion has been associated with experiencing less fear, catastrophic 
thoughts, avoidance behavior and better recovery from negative affect as compared to 
suppression25. Women coping with BC who were less accepting of their emotions also reported 
greater distress26 and sickness symptoms27.  
2.3 There are ethno-cultural differences in response to cancer diagnosis. Women from 
traditional backgrounds, in which there is an emphasis on collectivism as opposed to individualism 
and a reliance on religion as a major coping strategy, may respond differently to cancer diagnosis 
and treatment than do more modern/secular women. Women from traditional backgrounds may 
see cancer diagnosis as fate and fear stigma related to exposing their diagnosis28. Furthermore, 
out of fear of their loss of role in the traditional family, women may not express their distress 
openly, which leaves them at risk for loneliness and not receiving help for their symptoms28-30. BC 
survivors from ethnic minorities report poorer social, emotional, spiritual and physical quality of 
life31. Since expression of emotion and venting is distressing for some ethnic minorities32,33, art 
making and the use of metaphors as a form of emotion processing may be less distressing and 
more helpful in reducing symptoms and increasing quality of life34,35. Israel is a multi-cultural 
country with differences between the Jewish and Arab population. Israeli Arabs of different 
subgroups in comparison to Israeli Jews were found to be more conservative and hierarchical, 
and less autonomous36-38.  
2.4 Art Therapy interventions encourage emotion processing. Art therapy is a form of 
psychotherapy that involves the use of visual art-making (drawing, painting, sculpting, collage, 
etc.) for expression and communication within a safe and supportive relationship, in a 
therapeutic setting39. The Art Therapy session includes (i) an introductory period in which the 
therapist engages with participants to establish rapport and begins to understand participants' 
current state of mind, (ii) an art making period which entails much of the time, and (iii) a 
processing period in which the art made is looked at and discussed. Art Therapy has been well 
documented in cancer settings to alleviating psychological symptoms and reducing physical 
complaints40-44. In a qualitative study, women with breast cancer reported that art making was 
helpful through increased access to emotional content and its expression45. 
 

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We hypothesize that increased Emotion Processing is a primary mechanism through which Art 
Therapy effects psychological and physical symptom reduction in breast cancer patients. 
2.5 Heart rate variability and inflammation are related to emotion processing and 
depression, anxiety, fatigue and pain.  
The cholinergic anti-inflammatory pathway is comprised of vagus nerve signals leading to 
acetylcholine-dependent interaction with the alpha 7 nicotinic acetylcholine receptor subunit 
(a7nAChR) on monocytes and macrophages, resulting in reduced cytokine production46. Vagal 
modulation is related to physiological adaptability and emotional regulation53. Decreased vagus 
nerve activity and the associated loss of the tonic inhibitory influence of the cholinergic anti-
inflammatory pathway on innate immune responses and cytokine release, are hypothesized to 
pathologically enhance cytokine responses to stimuli, such as psychological stress47. Heart rate 
variability (HRV) is a measure of beat-to-beat temporal changes in heart rate and these changes 
reflect the output of the central autonomic network. The vagus nerve is a core component of the 
parasympathetic nervous system (PNS) within the central autonomic network and it regulates 
metabolic output in response to environmental stimuli and enables social engagement48. HRV 
can encompass both Sympathetic nervous system and PNS influences, but our primary interest 
is on the PNS influences, and at rest, a majority of HRV is related to PNS influence. In reviewing 
the literature, which reports a wide variety of metrics, we will use the more general term HRV, 
whereas our specific hypotheses will involve the subset of HRV that is specifically linked to PNS 
influence: high frequency (HF) HRV that reflects respiratory sinus arrhythmia (RSA) 49. 
The neuro visceral-integration model views psychopathology such as anxiety being ‘stuck’ in 
a behavioral pattern that is not responsive to the demands placed upon it by the environment54 50 
and asserts that lower HRV is associated with poor health because it reflects excess allostatic 
load as indexed by excess pro-inflammatory cytokines47. High levels of pro-inflammatory 
cytokines and low HRV are related to depressed mood, fatigue and pain in cancer patients51-
54 
Low HRV has been linked to difficulties in emotion regulation55-57 in the prediction of anxiety 
in BC patients62, and reports of sadness and crying in depressed individuals58,59. Disrupted 
nocturnal sleep was related to lower HRV the following day along with a flattened diurnal cortisol 
rhythm in women with metastatic BC60,61.  

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3. STUDY DESIGN 
We will accomplish the aims by a randomized controlled trial of 240 Jewish and Arab women (>18 
years) who have been diagnosed with BC and have completed chemotherapy, recruited in Israel 
and randomized to undergo an 8-week (1.5 hours per week) program of group Art Therapy 
compared to women who will be designated to an 8-week sham Art Therapy group. We chose 
this design to be able to isolate and examine emotional processing and the effect of enhancing 
emotional processing on HRV and inflammatory cytokines and examine how these may mediate 
the effect of art therapy on depressive symptoms, pain and fatigue.  
The primary outcomes are emotion processing, comprised of emotion awareness, expression and 
acceptance and the cholinergic anti-inflammatory pathway, comprised of resting HRV and 
inflammatory (pro and regulatory) cytokines.  The secondary outcome measures are depression, 
pain and fatigue.  
The study will take place at the cancer centers of 3 study sites: Rabin Medical Center, Rambam 
Medical Center and Ziv Medical Center, the enrollment period will vary until each cohort is 
collected and is expected to be approximately a month or a month and a half.  
The interventions will be administered by an experienced Art Therapist who will be trained in this 
specific protocol by the PI Czamanski-Cohen who is an Art Therapy Professor. The intervention 
is designed to follow the Bodymind model of AT62. Each session will start with a ten-minute rapport 
building and touching base and continue with 50 minutes of art making in a calm and supportive 
environment. Art materials are on the table and after the art therapist provides a brief explanation 
of the use of the materials; participants are encouraged to explore and experience as they wish. 
The art therapist is present to guide and assist. Participants are encouraged to minimize 
conversation; instrumental music is played to encourage introspective experiences. The session 
ends with 30 minutes of processing and discussion in which each participant shares and briefly 
presents their work and group participants can respond and or provide support.   
The comparison group will meet for a half an hour. The interventionist will encourage the 
participants to color prefabricated shapes for 30 minutes. The same art materials as in the 
intervention group will be on the table as will the same instrumental music. We will not be 
controlling for the whole 90 minutes of the intervention group as are concerned that comparison 
group participants will become bored and this will defeat the purpose of the comparison group. 
The detailed role of the interventionist is described in section 5.2, and it is tailored to ensure 
optimal opportunities for participants to engage in emotional processing in a supportive 
environment.  

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The interventionists of both groups will keep scores that will be rated by the PI against the 
treatment manual to ensure fidelity (see Table 2).  
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
We will accomplish the aims by recruiting 240 Jewish and Arab Women (>18 years) who have 
been diagnosed with breast cancer and have completed chemotherapy and are still undergoing 
some form of treatment, to include adjuvant treatment or within 5 years of completing 
chemotherapy, surgery and/ or radiation therapy. There is evidence that elevated depression, 
anxiety, fatigue and pain continue over 5 years of survivorship. We plan to recruit 50% Jewish 
women and 50% Arab women (30% more than represented both in general society and in the 
cancer population), for comparison. We plan to identify and approach women as they come in for 
their simulation visit to Radiation Oncology as this usually occurs about a week before radiation 
therapy starts and will be a good time to obtain baseline measures, however each site nurse will 
have the freedom to recruit patients who fit the enrollment criteria at other stages of treatment, 
after chemotherapy. The site nurse will be in charge of identifying and recruiting appropriate 
candidates for the trial and will use a screening log in order to document reasons for ineligibility 
or non-participation for eligible candidates. 
4.1      Inclusion Criteria 
1) adult (>18) females with initial or recurrent BC; 2) study entry within one year of diagnosis and 
3 months after adjuvant cancer care (chemotherapy and radiotherapy (RT)) or reconstructive 
surgery; any additional or replacement standard medical treatment for cancer is allowed (i.e., 
surgery, chemotherapy, radiotherapy, neo-adjuvant chemotherapy, endocrine therapy); 4) 
additional medication is allowed, excluding what is described in exclusion criteria, and will be 
assessed for potential inclusion as a covariate; 5) can complete assessments in Arabic or 
Hebrew; 6) provides informed consent.  
4.2 
Exclusion Criteria 
1) male (While we are aware of the NIH preference for studying men with BC, there presence 
would likely reduce the feeling of safety within the groups due to the sensitive subject matter); 2) 
lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or with a pre-cancer 
diagnosis of fibromyalgia or chronic fatigue syndrome 3) active suicidal plan (will ensure 
immediate intervention); 4) dementia/other disorder that would preclude informed consent or 
comprehension of assessments; 5) Individuals taking anticholinergic medications, and post 
myocardial infarction (6 months before recruitment) or with a pacemaker, which would render the 

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metric of HRV invalid. 6) Flare-up in systemic autoimmune disease (such as arthritis, lupus or 
multiple sclerosis), thyroid dysfunction that requires increases in medication  
We will inquire about and document any illness in the previous week with infection or acute viral 
disease as well as having dental work63 to account for these in our analyses. Additionally, should 
we encounter 6 or more men with BC we will conduct an Art Therapy intervention group for 
qualitative data gathering. 
After assessing eligibility and providing verbal consent to be contacted the site nurse will 
document their contact information in the Screening Log. The research coordinator will contact 
the potential participant by phone and will schedule a face to face meeting with the eligible 
participant. During the face to face meeting the research coordinator will use the following script 
to inform the eligible participant about the study:  
“We are conducting a study about how art therapy is beneficial for Breast Cancer patients and 
survivors. Should you agree to participate in this study, you will be requested to provide your 
written consent to participate in the study. You will then be randomized to one of 2 types of Art 
interventions. The intervention period will be 8 weeks and the sessions will be between an hour 
to 1.5 hours each week, depending on which group you are randomized to. You will be requested 
to answer questionnaires for about half an hour twice before the 1st session, once in after the 
intervention and one more time 8 weeks after the intervention is over. In addition, before and after 
the intervention you will be requested to measure your heart rate and respiration for an hour using 
a bio-patch that is attached below your sternum with 2 Gel electrodes. For half of the time you will 
be answering a questionnaire and for the second half hour you will be resting and listening to 
music. You will also be requested to provide us with 10ccs of blood for the analysis of health-
related variables, such as cytokines.  Our goal is to investigate the effects of the intervention on 
different indicators of Quality of Life of Breast Cancer patients and survivors. You will be 
compensated for your time and transportation. Should you attend all study sessions you will 
receive the equivalent of $200US in NIS and you will receive a fraction of that sum calculated for 
the sessions you attended, if you do not attend them all. For each session you attend, you will 
receive compensation for public transportation costs to the site from your home and back. You 
can withdraw from the study at any point in time by contacting the research coordinator of the PI, 
Dr. Czamanski-Cohen”.  

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5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
Both interventions will be administered in a group format by a trained individual. Each session will 
be 1.5 hours (intervention) and an hour (comparison) once a week for 8 weeks. There is a risk of 
participants feeling distress due to the exposure to emotional content either discussed in the 
group or that arises in the art therapy intervention group.   The psychosocial team at each study 
site will be prepared to meet with any participant who requests so. Interventionists will be trained 
to identify and refer distressed participants to the psychosocial team.  
5.2 
Handling of Study Interventions  
Participants will be blinded to whether they are receiving the intervention or comparison group. 
The treatment protocol derives its theoretical framework from the Bodymind model of AT62 and 
from the application of Focusing to Art Therapy64,65 for the purpose of body awareness and 
developing a focusing (“being friendly, accepting, non-judgmental and welcoming to one’s inner 
felt sense”)66.  All sessions start with a ten-
minute rapport building and touching base 
and continue with 50 minutes of art making 
in a calm and supportive environment. Art 
materials are on the table and after the art 
therapist provides a brief explanation of the 
use of the materials; participants are 
encouraged to explore and experience as 
they wish. Group leader is present to guide 
and assist. The role of the art therapist is to 
encourage 
a 
non-judgmental 
and 
exploratory approach to artmaking in which 
the process is emphasized over product. 
The art therapist obtains these goals by 
creating an atmosphere that is calm and by 
remaining tuned in to the verbalizations and 
body language of participants. If needed she 
can provide individual attention that is 
geared toward neutralizing concerns regarding performance during the art making. This approach 
is defined as providing a “Third-hand” 67: assisting in problem solving and dilemmas related to the 
Figure 1: Flow chart of time-points 

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art making process. The art therapist encourages participants to refrain from conversation and 
instrumental music is played to encourage introspective experiences. The session ends with 30 
minutes of processing and discussion in which the art therapist requests each participant to share 
and briefly presents their work and group participants can respond and or provide support. The 
art therapist will remind group members to be respectful and non-judgmental toward other 
participants and themselves.  
Session 1: getting familiar and safe: An introduction to the group, the group leader will speak 
about motivation for exploration via art and remaining open to new experiences. The leader will 
introduce the art materials and art making from a non-judgmental stance and the importance of 
process of product. The concept of safe place will be introduced to the group and members will 
be asked to create a safe place via art.  The goals of this session: Rapport Building, Contract 
Building and getting familiar and comfortable with the art materials.  
Session 2: Art making will be exploratory in the framework of open studio in which a specific topic 
is not provided and participants are encouraged to explore the art materials. The goal of this 
session is to provide an experiential encounter with the art making process. There will be a 10-
minute Psychoeducation presentation on the nature of emotions at the beginning of the session.  
Session 3: Group members will introduce themselves to the group by making a drawing about an 
emotion. The goal of this session is to continue learning on the nature of emotions and increase 
awareness of emotion responding patterns. 
Session 4: The art therapist requests the participants to create an image of somethings that is 
distressful to them and sit with it for a while. Then, they are requested to create an additional 
drawing that changes one element of the distress drawing, a feature, a color, a shape, or just a 
change in composition. The images are discussed among group members and implications for 
real life situations are discussed.  The goal of this session is twofold- to identify the location of 
distress in the body, increase distress tolerance, cognitive flexibility and reframing.  
Session 5: This session is open studio in which participants are encouraged to engage freely with 
the art materials. The goal of this session is to help participants identify how they react and 
respond to their emotions and bring an awareness of emotional experiences and learn the skill of 
“Clearing the Space”-using artmaking to identify feelings and experiences without the need to 
identify with them.  
Session 6: Clients are requested to draw two sides of a current conflict in their life. It can be 
something small, like deciding where to go for lunch, or something large, like which treatment to 

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engage in. All conflicts are welcome, but it should have significance to its creator and be 
something that they are struggling with and would like to learn more about. After the drawing 
period, clients are requested to look at both options and examine their sensations, feelings and 
thoughts about each.  Their art, thoughts and feelings are shared with the group. The goal of this 
session is to increase cognitive flexibility and reframe. This means that through creating 2 pictures 
participants will be able to view a situation from 2 points of view and identify more than one option 
for coping with the conflict they presented.  
Session 7: Body image: In this module participants will create art using body outline templates as 
a framework for art making. The goal of this session is to increase introceptive awareness and 
assist in processing emotional content from implicit experience to explicit expression. Distress 
tolerance.  
Session 8: Summary: This session will be a summary of all that has been experienced and clients 
will be provided with a letter that summarizes their progress. Each client will receive a package of 
oil pastels and blank journal for the encouragement of their continued process at home. The goal 
of this session is to review achievements and encourage incorporating what was learned in day 
to day life after the intervention is over.  
The comparison group is designed to control for the impact of the aspect of the group experience 
that are not explicitly focused on emotional processing, ie, 
the time with art materials and focused attention aspects that 
occur during an Artmaking session.  These sessions will not 
have a rapport building component and will include 40 
minutes of coloring pre-fabricated shapes (Mandalas- see 
figure 3) in a calm environment and 20 minutes of self-care 
instruction. Coloring Mandala’s has been demonstrated to 
reduce anxiety68-70.  Participants are encouraged to minimize 
conversation; instrumental music is played to encourage 
introspective experiences.  Due to our concerns that 
participants will become bored after more than 40 minutes of coloring we will not be equally 
comparing the amount of time that participants are together in the group format.  
5.3 
Concomitant Interventions  
5.3.1 Allowed Interventions 
Any standard medical treatment for cancer is allowed (i.e., surgery, chemotherapy, radiotherapy, 
Figure 3: Mandala example

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neo-adjuvant chemotherapy, endocrine therapy). However, participants should not be on 
chemotherapeutic agents during the study period.   
5.3.2 Prohibited Interventions 
Participants should not be engaged in another form of Psychotherapy or support group at the time 
of the intervention. Anticholinergic medications and beta-blockers are prohibited as they render 
the HRV and cytokine measures invalid.  
5.4 
Fidelity Assessment  
Adherence to the study regimen will be defined as attending 80% of the group sessions, which 
will be monitored and recorded by the interventionist.  The moderation of the effect of attending 
less than 80% will be assessed and dealt with during data analysis. Furthermore, fidelity of the 
intervention itself will be ensured by scoring the sessions against the treatment manual and 
observational fidelity checks by the gold standard rater (PI Czamanski-Cohen initially and then 
trained PhD student 20% of sessions). Fidelity below an average of 4 will indicate the need for 
further training of the interventionist.  
 
 
Table 2 Fidelity assessment 
 
1 not at 
all 
2 a little 
bit 
3 neither 
yes or no 
4 quite a 
bit 
5 very 
much so 
Not 
applic-
able 
1. Was there a sense of calm in the 
room? 
1 
2 
3 
4 
5 
N/A 
2. Did you feel like you were able to 
support the participants? 
1 
2 
3 
4 
5 
N/A 
3. Were the participants deeply 
engaged in art making?  
1 
2 
3 
4 
5 
N/A 
4. Was the session divided in to 10-
minute intro, 60 minutes art making 
and 20 minutes discussion?  
1 
2 
3 
4 
5 
N/A 
5. Was the art making done with 
minimal conversations? 
1 
2 
3 
4 
5 
N/A 
6. Was the group discussion respectful 
and safe?  
1 
2 
3 
4 
5 
N/A 

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6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations
 
6.2 
Description of Evaluations  
6.2.1 Screening Evaluation 
During clinic hours, research staff at the oncology practices will introduce potentially eligible 
patients to the study using a verbal script. Interested patients (having received a letter, flyer or 
referral) will call our office and receive an initial phone screening to assess age, stage, and 
Hebrew or Arabic language use. If initial criteria are met, an in-person visit will be scheduled either 
in our University office or at one of the 3 hospital recruitment sites where private rooms are 
arranged, depending on convenience to prospective participants to complete evaluation of 
eligibility, including major clinical depression, detailed medical history and current medications.  
Consenting Procedure 
The research nurse will obtain verbal consent from the patient agreeing to participate in the 
screening session. During the screening session, there will be a single informed consent form 
that describes both the screening and study procedures. Once eligibility is established, Subject’s 
Consent Form and Health Information Privacy Protection Act (HIPAA) information will be reviewed 
and, if consenting, participants will sign. Each site will have a designated MD or nurse to review 
documents related to medical and symptom-based eligibility criteria. Informed consent will be 
documented on a University of Haifa Ethics committee-approved form. A copy of the signed form 
will be given to the subject.  Signed consent forms will be kept in Dr. Czamanski-Cohen’s office, 

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which is an administrative office separate from research data and available for audit even when 
the PI is not. Additional information contained in a case book will be relevant demographic and 
medical/psychiatric information about the subject obtained during the interview with the site 
representative. Because this case book will contain personal identifiers and PHI, it will be kept 
separate from any data gathered as part of the study, and will be kept in a locked office. After 
consent is obtained, potential subjects will be screened by study personnel to determine that the 
subject meets all inclusion and exclusion criteria for study participation. 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrollment date is considered immediately following the signing of the consent form after which 
the enrollment date is recorded in the case book. The participant will be scheduled for a baseline 
visit in which she will be requested to fill out the baseline questionnaires and provide half an hour 
of baseline HR and Respiration measurements and 10 ccs of blood. Following this session, the 
participant will be randomized to the intervention or comparison group.  
Baseline Assessments Visit 1 day 0- can be split in to 2 visits to reduce patient burden (see 
study schema- figure 1) 
T1A 
DEMOGRAPHICS AND TRADITIONALISM 
A. 
We will be collecting baseline demographic data (age, marital status, children (if yes, 
and how many), religion, religiosity, education, employment, residence (city, village, etc).  
B.  We will measure ethnocultural differences using the Portrait Values Questionnaire (PVQ-RR), 
which is a 57-item scale consisting of items designed to measure 19 cultural values43. The scale 
has been validated in 15 samples across 10 countries (n=6059) including Israel. The mean 
Cronbach α for the tradition values (which we will use as a covariate to enrich the ethno-cultural 
differences between Jews and Arabs, was 0.8343.   
 
 
 
 
 

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C. CHOLINERGIC ANTI-INFLAMMATORY PATHWAY  
A. HRV: 20 minutes of resting ECG data will be recorded. The participants will be given 
instructions not to drink coffee or smoke for several hours before the lab visit as well as to sit 
quietly without talking or moving during the ECG recording.  
B. Inflammation: We will collect 10 cc’s of blood in order to measure immune dysregulation (pro-
inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory 
cytokine (TGF-β).   
D. PATIENT REPORTED OUTCOMES (PRO): 
A. Depression: The Center for Epidemiologic Studies-Depression (CES-DR) scale71- 10 ITEM 
SCALE.   
B. Fatigue will be assessed using the Fatigue Symptom Inventory (FSI)72.  
C. Pain: The Breast Cancer Prevention Trial (BCPT) Symptom Scales73. The PROMIS Pain 
Impact Scale74 measures how much pain interfered with different aspects of life in the past 4 
weeks. 
T1B  
A. The Levels of Emotional Awareness Scale is a written performance index of variation in the 
differentiation and complexity of emotional words used to answer the question “how would you 
feel and how would the other person feel” when presented with 10 evocative scenarios75.  
B. Emotional Approach Coping scales (e.g., emotional processing, emotional expression76) 
and COPE avoidance-oriented coping subscales (e.g., denial, mental disengagement77), all 
completed with reference to women’s experience of breast cancer.  
C. The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and 
nurturing toward their feelings26.  
B. Fatigue will be assessed using the Fatigue Symptom Inventory (FSI) 72. 
Randomization 
Randomization will occur immediately following the baseline visit which will occur within 14 days 
of the screening visit and one week before the intervention begins. The University statistician will 
generate numbered envelopes to be opened consecutively as subjects enroll and the envelopes 
will designate individuals to the intervention through use of a random numbers table. 

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6.2.3 Blinding 
Participants will be blinded to their randomization as will the research nurses and research 
coordinators.  
 
6.2.4 T 2 – POST intervention 
EMOTION PROCESSING 
A. The Levels of Emotional Awareness Scale is a written performance index of variation in the 
differentiation and complexity of emotional words used to answer the question “how would you 
feel and how would the other person feel” when presented with 10 evocative scenarios 75,78.  
B. Emotional Approach Coping scales (e.g., emotional processing, emotional expression 
79,80) and COPE avoidance-oriented coping subscales79 (e.g., denial, mental disengagement), 
all completed with reference to women’s experience of breast cancer.  
C. The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and 
nurturing toward their feelings24.  
D. PATIENT REPORTED OUTCOMES (PRO): 
A. Depression: The Center for Epidemiologic Studies-Depression (CES-DR) scale71- 10 ITEM 
SCALE.   
B. Fatigue will be assessed using the Fatigue Symptom Inventory (FSI)72.  
C. Pain: The Breast Cancer Prevention Trial (BCPT) Symptom Scales73. The PROMIS Pain 
Impact Scale74 measures how much pain interfered with different aspects of life in the past 4 
weeks.  
CHOLINERGIC ANTI-INFLAMMATORY PATHWAY  
A. HRV: 20 minutes of resting ECG data will be recorded. The participants will be given 
instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly 
without talking or moving during the ECG recording. 
B. Inflammation: We will collect 10 ccs of blood in order to measure immune dysregulation (pro-
inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory 
cytokine (TGF-β).   
T3-8 WEEKS AFTER END OF INTERVENTION Completion/Final Evaluation 

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CHOLINERGIC ANTI-INFLAMMATORY PATHWAY  
A. HRV: 20 minutes of resting ECG data will be recorded. The participants will be given 
instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly 
without talking or moving during the ECG recording. 
B. Inflammation: We will collect 10 ccs of blood in order to measure immune dysregulation (pro-
inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory 
cytokine (TGF-β).   
D. PATIENT REPORTED OUTCOMES (PRO): 
A. Depression: The Center for Epidemiologic Studies-Depression (CES-DR) scale71- 10 ITEM 
SCALE.   
B. Fatigue will be assessed using the Fatigue Symptom Inventory (FSI)72.  
C. Pain: 4 pain specific items to assess pain from the Breast Cancer Prevention Trial (BCPT) 
Symptom Scales73. In addition, we will use the 6 items for pain from the PROMIS Pain Impact 
Scale74 measuring how much pain interfered with different aspects of life in the past 4 weeks. 
EMOTION PROCESSING 
A. The Levels of Emotional Awareness Scale is a written performance index of ability to 
express emotion in a differentiated and complex way.  
B. Emotional Approach Coping scales (i.e., emotional processing, emotional expression80 
and COPE avoidance-oriented coping subscales79 (e.g., denial, mental disengagement, all 
completed with reference to women’s experience of breast cancer.  
C. The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and 
nurturing toward their feelings24.  
7. SAFETY ASSESSMENTS  
7.1 Specification of Safety Parameters 
      N/A  
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
N/A 
7.3   Adverse Events and Serious Adverse Events  
An adverse event (AE) is generally defined as any unfavorable and unintended diagnosis, 

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symptom, sign (including an abnormal laboratory finding), syndrome or disease which either 
occurs during the study, having been absent at baseline, or if present at baseline, appears to 
worsen. Adverse events are to be recording regardless of their relationship to the study 
intervention.   
A serious adverse event (SAE) is generally defined as any untoward medical occurrence that 
results in death, is life threatening, requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly. 
Adverse events are not expected because of the intervention or comparison groups.  
7.4 Reporting Procedures 
PI’s Czamanski-Cohen and Weihs will create a Data and Safety Monitoring Board (DSMB), 
which will meet at approximately six-month intervals. DSMB members will represent expertise in 
psycho-oncology and in research monitoring. Members of the committee will agree to keep all 
information confidential. The board members will review summaries of study progress to ensure 
that consent documentation is properly obtained and stored. They will review progress in subject 
recruitment and anticipated race/ethnicity participant representation. They will determine whether 
study coordinators and investigators are collecting and organizing data properly.  
7.5 
Safety Monitoring  
PI Czamanski-Cohen will closely monitor and supervise the research team at their respective 
sites, as well as conduct coordinated oversight of psychological status of all participating women 
taking part in the research. She will consult with PI Weihs with any concern or consideration. PI 
Czamanski-Cohen will also meet regularly with the research teams at the clinical sites and the 
University every other week to ensure appropriate conduct.  
INTERVENTION DISCONTINUATION 
Should the PI or site PI discover based on research nurse, patient reports or assessments of 
outcomes in the initial cohort that the intervention is causing harm rather than benefit (statistically 
significant mean increases in depression) the intervention will be discontinued.  
 
8. STATISTICAL CONSIDERATIONS  
8.1 
General Design Issues  
A randomized trial with careful controls was chosen to control for the active mechanism of emotion 
processing that we expect to increase following the art therapy intervention. Our comparison 

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group is designed to entails aspects of art therapy, such as engaging with art materials and being 
in a group setting that we believe are not related to the mechanism at hand.  
8.2 
Sample Size and Randomization 
A power analysis was conducted via Monte Carlo simulation in Mplus showed that a sample size 
of 240 (120 per condition), provides: (1) >90% power to detect a moderate effect size (Cohen’s d 
= 0.50) of treatment on mechanisms, (2) >90% power to detect a moderate association (r = 0.30) 
between mechanisms and symptoms, and (3) >90% power to detect an indirect effect from 
treatment to symptoms via mechanisms. The sample size will also provide >80% power to detect 
a moderate effect size for the Condition by Ethno-Cultural group interaction. 
Consented participants will be randomized into the Art Therapy or Sham condition using block 
randomization stratified by site, ethnicity and traditionalism to ensure equal sample sizes between 
groups over time in each site and in each ethnicity. Permutations of group assignment will be 
generated in random blocks of 4, 6, and 8 so that staff cannot guess the condition of the final 
participant as the block size varies. Condition assignment will be stored in sealed, numbered 
envelopes to be opened consecutively as subjects enroll and the envelopes will designate 
individuals to the intervention through use of a random numbers table. PI Czamanski-Cohen will 
provide the PhD students with the randomized lists (60 each cohort), who will schedule sessions 
and make weekly calls to encourage attendance, therefore both will be un-blinded to study 
assignment. The Research Nurse will collect and enter data, collect bio specimens and manage 
the database, and thus will be un-blinded after randomization. The research assistant (RA) will 
remain blinded throughout the study, and will receive lists of participants to call, without knowing 
which group they are assigned to. Participants will be told they are participating in an “art making” 
study where they will be assigned to an art making group. Participants will not be told which is 
expected to be superior. 
8.3    Treatment Assignment Procedures  
Consented participants for each cohort will be randomized (PI- Czamanski-Cohen) The University 
statistician will generate numbered envelopes to be opened consecutively as subjects enroll and 
the envelopes will designate individuals to the intervention through use of a random numbers 
table. PI Czamanski-Cohen will provide the PhD students with the randomized lists (60 each 
cohort), who will schedule sessions and make weekly calls to encourage attendance and conduct 
the intervention and thus will be unblinded. The Research Nurse will collect and enter data, collect 
bio specimens and manage the database, but will remain blinded after randomization. The 
research assistant will remain blinded throughout the study, and will receive lists of participants 

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to call, without knowing which group they are assigned to. Participants will be told they are 
participating in an “art making” study where they will be assigned to either the intervention group 
or the sham intervention (Mandala) group. Participants will not be told which is expected to be 
superior. 
 
 
 
Table 4: Roles in the study 
Title 
Blinded to 
group 
assignment 
Roles 
Rambam 
Ziv 
Beilin-
son 
Research nurse 
(employee of each 
hospital). 
Yes 
Recruit and obtain verbal 
consent, collect blood. 
1 
1 
1 
Research coordinator 
(employee of each 
hospital). 
Yes 
Assist MD in recruiting 
patients, 
collect 
data 
(questionnaires and HRV), 
transfer blood to the lab for 
processing (separation to 
serum, divide in 4 aliquots 
and cryopreservation -80) 
1 
1 
1 
Art Therapist 
No 
Conduct 
intervention 
groups (8.5 weeks)- Art 
Therapy and SHAM in 
Hebrew or Arabic 
2 
2 
2 
PhD student  
No 
Conduct groups, supervise 
interventionists, assist in 
fidelity assurance, assist in 
data analysis. 
3 
Laboratory worker 
Yes 
Conduct 
inflammatory 
cytokines analysis. 
1 
Research coordinator 
Yes 
Coordinate between study 
site, transport frozen serum 
to lab, input data 
1 
 
 
 
 
 
9. DATA COLLECTION AND QUALITY ASSURANCE 
9.1 
Data Collection Forms  
PI Czamanski-Cohen will provide the research coordinators with the randomized lists (60 each 
cohort), who will schedule sessions and make weekly calls to encourage attendance, 
therefore both will be un-blinded to study assignment. The Research Nurse will collect and 
enter data, collect bio specimens and manage the database, and thus will be un-blinded after 
randomization. The research assistant will remain blinded throughout the study, and will 
receive lists of participants to call, without knowing which group they are assigned to. Signed 

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consent forms and all study questionnaires will be kept in an administrative office separate 
from research data and available for audit even when the PI is not. Additional information 
contained in this case book will be relevant demographic and medical/psychiatric information 
about the subject obtained during the interview with the site representative. Because this case 
book will contain personal identifiers and PHI, it will be kept separate from any data gathered 
as part of the study and will be kept in a locked office.  
9.2 
Data Management  
At the point of first contact by potential participant contacting us, a brief overview of the study 
will be provided by the study coordinator. At screening, the consent form will be reviewed, and 
potential subjects will have an opportunity to address any concerns they might have. During 
this conversation, the detailed nature, purpose, procedures, benefits, risks of, and alternatives 
to this study will be explained to each subject and written informed consent will be obtained 
by the site PI. Informed consent will be documented on a Hospital IRB-approved form. A copy 
of the signed form will be given to the subject. Signed consent forms will be kept in a locked 
office in the hospital, which is an administrative office separate from research data and 
available for audit even when the PI is not. Additional information contained in this case book 
will be relevant demographic and medical/psychiatric information about the subject obtained 
during the interview with the site representative. Because this case book will contain personal 
identifiers and PHI, it will be kept separate from any data gathered as part of the study and 
will be kept in a locked office. After consent is obtained, potential subjects will be screened by 
study personnel to determine that the subject meets all inclusion and exclusion criteria for 
study participation. The contact MD at each site will be contacted immediately in the event of 
a subject meeting criteria for major depression or any other acute untreated psychiatric 
condition or for suicidal ideation. All such subjects will be evaluated for the need for acute 
hospitalization for safety and will be given appropriate treatment referrals. 
9.3 
Quality Assurance  
9.3.1 Training 
Interventionists will be experienced MA level art therapists who will be trained by PI Czamanski-
Cohen and the PhD students. Weekly and bi-weekly training session will be conducted prior to 
commence of the proposed research, and PI Czamanski-Cohen will be available for additional 
support and guidance as needed.  

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To ensure the quality and consistency of the intervention the interventionists of both the 
intervention and comparison groups will be scored each session (see Table 2) and against the 
treatment manual reviewed by the blinded RA. Discrepancies will be flagged and then reviewed 
by PI Czamanski-Cohen, who will subsequently address this with the intervention team for 
correction. Adherence to the study regimen will be defined as attending 80% of the group 
sessions, which will be monitored and recorded by the interventionist.  
Each of the three hospitals that have approved their participation in this study have an 
independent Institutional Review Board (IRB), which approve the conduct of clinical trials. The 
boards strictly adhere to the Helsinki Treaty on Human Medical Experimentation. Hospitals 
consent to the Public Health Regulations (Medical Experiments in Human Subject) – 1980 of 
Israel Ministry of Health, including additions and amendments, and operate in accordance with 
the regulations for conducting Medical Trials on Humans – 1999 of the Pharmacological Unit of 
the Israel Ministry of Health provisions of the current Harmonized International Guidelines for 
Good Clinical Practice namely: ICH-GCP. 
9.3.2 Safety Monitoring Committee (SMC) 
PI’s Czamanski-Cohen and Weihs will create a Safety Monitoring Committee (SMC), which will 
meet at approximately six-month intervals via Skype or Zoom, as the committee is comprised of 
individuals in different locations. SMC members will represent expertise in psycho-oncology, in 
research monitoring and statistics. Members of the committee will agree to keep all information 
confidential. The committee members will review summaries of study progress to ensure that 
consent documentation is properly obtained and stored. They will review progress in subject 
recruitment and anticipated race/ethnicity participant representation. They will determine whether 
study coordinators and investigators are collecting and organizing data properly.  
 
Data and Safety Monitoring 
a.   The SMC will monitor the study. The SMC is comprised of the following individuals: 
Dr. Tzipi Hornik-Lurie who has a background in epidemiology, statistics and public health 
and mental health research, she will monitor data collection and documentation as well as 
examine the data checks.  
Prof. Hadas Goldblatt who specializes in nursing research, and Psycho oncology and will 
oversee examining the fidelity checks and proper implementation of the intervention, subject 
recruitment and anticipated race/ethnicity participant representation.  
Both PI’s will be on the SMC  

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Co-I Dr. Joshua Wiley, who oversees the statistical analyses will also be part of the SMC.  
PI Dr. Czamanski-Cohen will be responsible for submitting necessary reports to NINR.  
 
b.   Monitoring schedule for study safety: The PI will review all events and unanticipated 
problems on a weekly basis. The SMC will monitor study safety bi-annually. Confidentiality: 
Study staff will notify the PI immediately of any breaches in participant confidentiality. The PI 
will notify SMC, IRB and NINR of breaches in confidentiality within 24 hours or notification by 
study staff. 
  
Compliance of regulatory documents and study data accuracy and completeness will be 
maintained through an internal study team quality assurance process. Quality control will 
include semi-annual data verification and protocol compliance checks by the PI, Co-Is, and 
the Safety Monitoring Committee (SMC). Protocol adherence will be monitored by the PI and 
the SMC by auditing 5 cases semi-annually for compliance with IRB requirements, compliance 
with informed consent requirements, verification of source documents and compliance with 
the study protocol. 
 
c. Identification of AEs/unanticipated problems:  
Adverse event. For this study, since our subjects are breast cancer patients, they are likely 
to have many changes in their health status that are related to the time during treatment that 
they are participating in the study.   Thus, since this is not a medical intervention study we will 
record only AEs that are possibly or definitely related to study participation. The following 
standard AE definitions are used: 
Serious adverse event. An AE that results in any of the following: 
• Death 
• Life-threatening condition 
• Inpatient hospitalization or prolongation of existing hospitalization 
• Persistent or significant disability/incapacity 
Not related. An AE for which a cause outside the study procedures is most plausible and/or 
a clinically plausible temporal sequence is inconsistent with the onset of the event. 
Possibly related. An AE that follows a reasonable temporal sequence from the initiation of 
study procedures, but that could readily have been produced by a number of other factors. 
Related. An AE that is clearly linked to the study procedures. 

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Review of AEs: The PI will compile quarterly report to the SMC detailing the study progress 
and participant status, any related or possibly related adverse events (AEs), and any protocol 
deviations. Unrelated or possibly related AEs will be reported to NINR in the yearly RPPR 
unless the event or unanticipated problem will affect the study risk level or progress, In this 
case, the PI will notify NINR staff within one week of completing the report.  
Reporting of AEs: Serious Adverse Events will be reported immediately to the PI by study 
staff. The PI will report to SMC, IRB, NINR within 24 hours of notification by study staff. The 
PIs will follow OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving 
Risks to Subjects or Others and Adverse Events.   
d. Multisite reporting: PI Czamanski-Cohen will report “unanticipated problems” involving risks 
to participants to the IRB, as well as NINR unrelated to the bi-annual reports of the monitoring 
committee that will submitted by the PIs. PI Czamanski-Cohen will distribute the bi-annual and 
special (if unanticipated problems arise) reports to all site PIs for submission to their local 
IRBs. The SMC will also ensure compliance with the monitoring plan and reporting 
requirements across study sites. PI Czamanski-Cohen will meet on a regular basis (every 3 
months, at minimum) with all study staff to ensure compliance with the monitoring plan and 
reporting requirements across study sites. Furthermore, she will make sure the SMC is 
monitoring study progress as delineated above and submit reports as stated 
e.  The PI’s will conduct an ongoing assessment of external factors or relevant information (e.g., 
developments in the literature, results of related studies) that may have an impact on the 
safety of participants or on the ethics for the research study. 
f.  The interim analysis will take place at the end of the first year of the study (after 6 months of 
data collection) and at the end of the second year (after 18 months of data collection). Since 
this is a mechanistic study, we are not concerned about not finding statistically significant 
differences between the groups, however, our pilot study findings do indicate that we should. 
In the case of unexpected findings, we will further explore the fidelity assessments to ensure 
the interventions are being conducted as designed (above and beyond the ongoing fidelity 
checks in place. PI Czamanski-Cohen will closely monitor and supervise the research team 
at their respective sites, as well as conduct coordinated oversight of psychological status of 
all participating women taking part in the research. She will consult with PI Weihs with any 
concern or consideration. PI Czamanski-Cohen will also meet regularly with the research 
teams at the clinical sites and the University every other week to ensure appropriate conduct.  

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9.3.3 Monitoring 
PI Czamanski-Cohen will closely monitor and supervise the research team at their respective 
sites, as well as conduct coordinated oversight of psychological status of all participating women 
taking part in the research. She will consult with PI Weihs with any concern or consideration. PI 
Czamanski-Cohen will also meet regularly with the research teams at the clinical sites and the 
University every other week to ensure appropriate conduct.  
All local legal requirements regarding protection of personal data must be adhered to. 
To ensure the quality and consistency of the intervention administration both the intervention and 
comparison groups in both Hebrew and Arabic will be scored against the treatment manual, using 
a check list which will be assessed daily by the research assistant who is blind to group allocation. 
Adherence to the study regimen will be defined as attending 80% of the group sessions, which 
will be monitored and recorded by the interventionist. Participant confidentiality will be well 
protected, as any data, specimens, forms, reports, and other records that leave the site will be 
identified only by a participant identification number (PID). All records will be kept in a locked file 
cabinet. All computer entry and networking programs will be done using Patient ID numbers only. 
Information will not be released without written permission of the participant, except as necessary 
for monitoring by IRB. 
The Board will issue a report every six months to the PI and annually to the IRB. 
 
 
 
 
 
 
 
9.3.4 Protocol Derivations 
 
Should the PI identify discrepancies between the treatment manual and the fidelity scores PI 
Czamanski-Cohen will immediately engage with the interventionist to discuss and provide 
guidance for getting back on track of the treatment protocol.   
 
10. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
10.1 
Institutional Review Board (IRB) Review  
This protocol and the informed consent document and any subsequent modifications 
will be reviewed and approved by the IRB or ethics committee responsible for oversight 

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of the study. The consent form should be separate from the protocol document.  
10.2 
Informed Consent Forms 
A signed consent form will be obtained from each participant. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A copy will be given to each participant or legal guardian and 
this fact will be documented in the participant’s record.  
10.3 
Participant Confidentiality  
Any data, specimens, forms, reports, video recordings, and other records that leave 
the site will be identified only by a participant identification number (Participant ID, PID) 
to maintain confidentiality. All records will be kept in a locked file cabinet. All computer 
entry and networking programs will be done using PIDs only. Information will not be 
released without written permission of the participant, except as necessary for 
monitoring by IRB, the FDA, the NIH, and the OHRP. 
10.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIH, the OHRP, the FDA, 
or other government agencies as part of their duties to ensure that research 
participants are protected.  
 
 

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14 OCT 2018 
REFERENCES  
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17. 
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18. 
Stanton AL, Danoff-Burg S, Huggins ME. The first year after breast cancer diagnosis: hope 
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Hoyt MA, Austenfeld J, Stanton AL. Processing coping methods in expressive essays 
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21. 
Rost AD, Wilson K, Buchanan E, Hildebrandt MJ, Mutch D. Improving Psychological 
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Low CA, Stanton AL, Danoff-Burg S. Expressive disclosure and benefit finding among 
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23. 
Stanton AL, Danoff-Burg S, Cameron CL, et al. Emotionally expressive coping predicts 
psychological and physical adjustment to breast cancer. J Consult Clin Psychol. 
2000;68(5):875-882. 
24. 
Politi MC, Enright TM, Weihs KL. The effects of age and emotional acceptance on distress 
among breast cancer patients. Support Care Cancer. 2007;15(1):73-79. 
25. 
Gross JJ, John OP. Individual differences in two emotion regulation processes: 
implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003;85(2):348. 
26. 
Politi MC, Enright TM, Weihs KL. The effects of age and emotional acceptance on distress 
among breast cancer patients. Support Care Cancer. 2007;15(1):73-79. 
27. 
Reed RG, Weihs KL, Sbarra DA, Breen EC, Irwin MR, Butler EA. Emotional acceptance, 
inflammation, and sickness symptoms across the first two years following breast cancer 
diagnosis. Brain Behav Immun. 2016. 
28. 
Azaiza F, Cohen M. Health beliefs and rates of breast cancer screening among Arab 
women. J Womens Health. 2006;15(5):520-530. 
29. 
Goldblatt H, Cohen M, Azaiza F. Expression of emotions related to the experience of 
cancer in younger and older Arab breast cancer survivors. Ethnicity & health. 2016:1-14. 
30. 
Azaiza F, Cohen M. Between traditional and modern perceptions of breast and cervical 
cancer screenings: a qualitative study of Arab women in Israel. Psycho‐Oncology. 
2008;17(1):34-41. 
31. 
Miller AM, Ashing KT, Modeste NN, Herring RP, Sealy D-AT. Contextual factors 
influencing health-related quality of life in African American and Latina breast cancer 
survivors. J Cancer Surviv. 2015;9(3):441-449. 
32. 
Goldblatt H, Cohen M, Azaiza F, Manassa R. Being within or being between? The cultural 
context of Arab women's experience of coping with breast cancer in Israel. Psycho‐
Oncology. 2013;22(4):869-875. 
33. 
Culver JL, Arena PL, Wimberly SR, Antoni MH, Carver CS. Coping among African-
American, Hispanic, and non-Hispanic White women recently treated for early stage 
breast cancer. Psychol Health. 2004;19(2):157-166. 
34. 
Dwairy M. Culture analysis and metaphor psychotherapy with Arab‐Muslim clients. J Clin 
Psychol. 2009;65(2):199-209. 
35. 
Dwairy M. A biopsychosocial model of metaphor therapy with holistic cultures. Clin 
Psychol Rev. 1997;17(7):719-732. 
36. 
Schwartz SH. Beyond individualism/collectivism: New cultural dimensions of values. Sage 
Publications, Inc; 1994. 
37. 
Schwartz SH, Cieciuch J, Vecchione M, et al. Refining the theory of basic individual 
values. J Pers Soc Psychol. 2012;103(4):663. 
38. 
Sortheix FM, Schwartz SH. Values that Underlie and Undermine Well‐Being: Variability 
Across Countries. Eur J Personality. 2017;31(2):187-201. 
39. 
Uttley L, Scope A, Stevenson M, et al. Systematic review and economic modelling of the 
clinical effectiveness and cost-effectiveness of art therapy among people with non-
psychotic mental health disorders. 2015. 
40. 
Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on 
psychological outcomes for adult cancer patients: a systematic review of randomised 
controlled trials. Psychooncology. 2014. 
41. 
Monti DA, Peterson C, Kunkel EJ, et al. A randomized, controlled trial of mindfulness-
based art therapy (MBAT) for women with cancer. Psychooncology. 2006;15(5):363-373. 
42. 
Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: 
innovative use of art therapy. J Pain Symptom Manage. 2006;31(2):162-169. 

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43. 
Oster I, Svensk AC, Magnusson E, et al. Art therapy improves coping resources: a 
randomized, controlled study among women with breast cancer. Palliat Support Care. 
2006;4(1):57-64. 
44. 
Svensk AC, Oster I, Thyme KE, et al. Art therapy improves experienced quality of life 
among women undergoing treatment for breast cancer: a randomized controlled study. 
Eur J Cancer Care (Engl). 2009;18(1):69-77. 
45. 
Collie K, Bottorff JL, Long BC. A narrative view of art therapy and art making by women 
with breast cancer. J Health Psychol. 2006;11(5):761-775. 
46. 
Huston JM, Tracey KJ. The pulse of inflammation: heart rate variability, the cholinergic 
anti‐inflammatory pathway and implications for therapy. J Intern Med. 2011;269(1):45-53. 
47. 
Thayer JF, Sternberg E. Beyond heart rate variability: vagal regulation of allostatic 
systems. Ann N Y Acad Sci. 2006;1088:361-372. 
48. 
Porges SW. The polyvagal perspective. Biol Psychol. 2007;74(2):116-143. 
49. 
Allen JJ, Chambers AS, Towers DN. The many metrics of cardiac chronotropy: a 
pragmatic primer and a brief comparison of metrics. Biol Psychol. 2007;74(2):243-262. 
50. 
Thayer JF, Lane RD. A model of neurovisceral integration in emotion regulation and 
dysregulation. J Affective Disord. 2000;61(3):201-216. 
51. 
Miller AH, Ancoli-Israel S, Bower JE, Capuron L, Irwin MR. Neuroendocrine-immune 
mechanisms of behavioral comorbidities in patients with cancer. J Clin Onco. 
2008;26(6):971-982. 
52. 
Kruse JL, Strouse TB. Sick and tired: mood, fatigue, and inflammation in cancer. Curr 
Psychiat Rep. 2015;17(3):1-11. 
53. 
Crosswell AD, Lockwood KG, Ganz PA, Bower JE. Low heart rate variability and cancer-
related fatigue in breast cancer survivors. Psychoneuroendocrino. 2014;45:58-66. 
54. 
Bower JE, Ganz PA, Irwin MR, Kwan L, Breen EC, Cole SW. Inflammation and behavioral 
symptoms after breast cancer treatment: do fatigue, depression, and sleep disturbance 
share a common underlying mechanism? J Clin Onco. 2011;29(26):3517-3522. 
55. 
Geisler FC, Vennewald N, Kubiak T, Weber H. The impact of heart rate variability on 
subjective well-being is mediated by emotion regulation. Pers Indiv Differ. 2010;49(7):723-
728. 
56. 
Geisler FC, Kubiak T, Siewert K, Weber H. Cardiac vagal tone is associated with social 
engagement and self-regulation. Biol Psychol. 2013;93(2):279-286. 
57. 
Williams DP, Cash C, Rankin C, Bernardi A, Koenig J, Thayer JF. Resting heart rate 
variability predicts self-reported difficulties in emotion regulation: a focus on different 
facets of emotion regulation. Front  Psychol. 2015;6. 
58. 
Rottenberg J. Cardiac vagal control in depression: a critical analysis. Biol Psychol. 
2007;74(2):200-211. 
59. 
Rottenberg J, Chambers AS, Allen JJ, Manber R. Cardiac vagal control in the severity and 
course of depression: the importance of symptomatic heterogeneity. J Affect Disor. 
2007;103(1):173-179. 
60. 
Giese-Davis J, Wilhelm FH, Tamagawa R, et al. Higher vagal activity as related to survival 
in patients with advanced breast cancer: An analysis of autonomic dysregulation. 
Psychosom Med. 2015. 
61. 
Palesh O, Zeitzer JM, Conrad A, et al. Vagal regulation, cortisol, and sleep disruption in 
women with metastatic breast cancer. JCSM. 2008;4(5):441. 
62. 
Czamanski-Cohen J, Weihs K. The Bodymind Model: A platform for the conduct of the 
mechanistic study of art therapy. Art Psychother. 2016;51:63–71. 
63. 
O’Connor M-F, Bower JE, Cho HJ, et al. To assess, to control, to exclude: effects of 
biobehavioral factors on circulating inflammatory markers. Brain Behav Immun. 
2009;23(7):887-897. 

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64. 
Gendlin ET. Experiencing and the creation of meaning. Free press of Glencoe New York; 
1962. 
65. 
Fritsche J. Mind-Body awareness in art therapy with chronic pain syndrome. In: Rappaport 
L, ed. Mindfulness and the Arts Therapies. London: Jessica Kingsley Publishers; 2014:81-
94. 
66. 
Rappaport L. Focusing-oriented art therapy: Accessing the body's wisdom and creative 
intelligence. Jessica Kingsley Publishers; 2008. 
67. 
Kramer E. Art as therapy: Collected papers. Jessica Kingsley Publishers; 2001. 
68. 
van der Vennet R, Serice S. Can Coloring Mandalas Reduce Anxiety? A Replication 
Study. Art Therapy. 2012;29(2):87-92. 
69. 
Curry NA, Kasser T. Can Coloring Mandalas Reduce Anxiety? Art Therapy. 
2005;22(2):81-85. 
70. 
Fincher SF. Creating Mandalas: For Insight, Healing and Self-Expression. Boston: 
Shambhala; 1991. 
71. 
Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the 
General Population. Appl Psych Meas. 1977;1(3):385-401. 
72. 
Hann DM, Denniston MM, Baker F. Measurement of fatigue in cancer patients: further 
validation of the Fatigue Symptom Inventory. Qual Life Res. 2000;9(7):847-854. 
73. 
Stanton AL, Bernaards CA, Ganz PA. The BCPT symptom scales: a measure of physical 
symptoms for women diagnosed with or at risk for breast cancer. J Natl Cancer I. 
2005;97(6):448-456. 
74. 
Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement 
Information System (PROMIS): progress of an NIH Roadmap cooperative group during its 
first two years. Med Care. 2007;45(5 Suppl 1):S3. 
75. 
Lane RD, Quinlan DM, Schwartz GE, Walker PA, Zeitlin SB. The Levels of Emotional 
Awareness Scale: A cognitive-developmental measure of emotion. J Pers Ass. 1990;55(1-
2):124-134. 
76. 
Stanton AL, Kirk SB, Cameron CL, Danoff-Burg S. Coping through emotional approach: 
scale construction and validation. Journal of personality and social psychology. 
2000;78(6):1150. 
77. 
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based 
approach. J Pers Soc Psychol. 1989;56(2):267-283. 
78. 
Lane R. LEAS scoring manual and glossary. Unpublished manual for the Levels of 
Emotional Awareness Test Available from Richard D Lane, General Clinical Research 
Center, University of Arizona, PO Box. 1991;245002:85724-85002. 
79. 
Stanton AL, Kirk SB, Cameron CL, Danoff-Burg S. Coping through emotional approach: 
scale construction and validation. J Pers Soc Psychol. 2000;78(6):1150-1169. 
80. 
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based 
approach. J Pers Soc Psychol. 1989;56(2):267. 
 
 
 
 
 
 

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11. SUPPLEMENTS/APPENDICES 
I. Procedures Schedule Oct. 2018- Sept. 2021. 
Table 3: Study Timeline 
Months 
1-6 
7-12 
13-18 
19-24 
25-30 
31-36 
Prep/Training 
X 
 
 
 
 
 
Team mtgs 
X4 
X4 
X2 
X1 
X2 
X6 
Intervention 
 
Cohort1 
Cohort 2 
Cohort 3 
Cohort 4 
 
Data chk** 
 
X 
 
X 
 
 
Analysis 
 
 
 
X (prelim)  
X 
Writing/discussion 
 
 
X 
 
 
X 
Presentation 
at 
Conferences 
 
 
 
 
 
X 
Travel 
Dr. 
Weihs to 
Israel- 
Nov. 
2018 
 
 
 
 
Drs. 
Czamanski-
Cohen, 
Wiley 
and 
Prof. Cohen 
to 
Tucson, 
AZ- spring/ 
summer 
2021 
Dr. Wiley 
to Israel 
Jan 2019 
Final cohort begins mo. 25, allows final data mo. 31. **Data check/quality. Balance across arms 
on factors used in minimization technique will be monitored and adjusted. 
 
 
 
 
 
 
 
 

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 II. Informed Consent Form Template 
 
Informed Consent form 
Name of Principal Investigators: Dr. Johanna Czamanski-Cohen and Dr. Karen Weihs 
You will be given a copy of the full Informed Consent Form 
 
Purpose of the research 
Breast cancer is the most common cancer that women suffer from. Many breast cancer survivors 
suffer from symptoms of depression, anxiety, pain and fatigue that negatively affect their quality 
of life. Art Therapy provides an alternative to verbal Psychotherapy and has been shown to help 
alleviate Psychological and Physical symptoms. The purpose of our research is to understand 
more about the ways in which art therapy helps BC survivors.  
 
Type of Research Intervention 
This research will involve your participation in one of two intervention groups that entail art making. 
Each group will take place for 8 weeks for either 1 ½ hours or 30 minutes. In addition, you will be 
requested to answer questionnaires for about an hour, once before the start of the intervention, 
once during the week after the intervention is over and once 8 weeks later. We will also request 
that you provide us with 10 ccs of blood at 3 time points, once before, once in the middle and 
once after the intervention. The blood will be drawn by a qualified nurse. Furthermore, you will be 
requested to sit for 20 minutes, 3 times while you are connected to a biopatch that collects data 
about your heart rate and breathing. The biopatch is a small round device that will be adhered to 
your skin for 20 minutes, at each collection point via 2 gel electrodes slightly below your sternum.  
Participant selection 
We are inviting all breast cancer survivors at this hospital who have completed chemotherapy to 
participate in this study.  
 
Voluntary Participation 
Your participation in this research is entirely voluntary. It is your choice whether to participate or 
not. Whether you choose to participate or not, all the services you receive at this clinic will continue 
and nothing will change. If you choose not to participate in this research project, you will be offered 

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14 OCT 2018 
the treatment that is routinely offered in this hospital for Breast Cancer, and we will tell you more 
about it later. You may change your mind later and stop participating even if you agreed earlier. 
The biological samples obtained during this research procedure will be used only for this research, 
and will be destroyed after 5 years, when the research is completed.  
B. Description of the Process 
Duration  
The research takes place over 16 weeks in total. During that time, it will be necessary for you to 
come to hospital 11 times, for 1-2hours each day. In total, you will be asked to come up to 11 
times to the clinic in 2.5 months. At the end of 3 months, the research will be finished. 
Time table of data collection and interventions 
Week 0 
Week 1-3 
Weeks 4-16 
Week 16 
Week 24 
Enrollment 
in 
Study 
Filling 
out 
questionnaires 
Intervention group 
at the hospital 1 
time a week for 1-
1.5-hours 
Filling 
out 
questionnaires 
Filling 
out 
questionnaires 
Signing 
informed 
consent 
10 cc of blood 
10 cc of blood 
10 cc of blood 
Randomization 
to intervention 
group 
20 minutes of EKG 
monitoring via the 
bio patch 
20 minutes of EKG 
monitoring via the 
bio patch 
20 minutes of 
EKG 
monitoring via 
the bio patch 
Risks 
We do not expect any risks from participating in this study, however, you may feel a temporary 
increase in emotional distress. Should you feel significant distress, we have professionals 
available to provide you with additional support. You will be asked to provide 20 cc of blood at 3 
time points and there may be some local discomfort associated with the needle prick. You will be 
asked to connect a biopatch to your chest using 2 electrodes, at 3 time points for 20 minutes 
each. You may have some minor and temporary skin irritation at the site of adherence. If you feel 
any emotional or physical distress related to the intervention or physiological data collection, 
please contact the research nurse for assistance.  
Benefits  
We believe that you may benefit from participating in this study by experiencing an alleviation of 
existing symptoms or prevention of depressive, anxiety, pain or fatigue that often accompany 
Breast cancer patients.  
 

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14 OCT 2018 
 
 
Reimbursements 
We will give you $67 USD to pay for your travel to the hospital for all the sessions and we will give 
you $200 USD for your time, should you complete all the sessions. You will not be given any other 
money or gifts to take part in this research.  
Confidentiality 
With this research, something out of the ordinary is being done in your community. It is possible 
that if others in the community are aware that you are participating, they may ask you questions. 
We will not be sharing the identity of those participating in the research.   
 
The information that we collect from this research project will be kept confidential. Information 
about you that will be collected during the research will be put away and no-one, but the 
researchers will be able to see it. Any information about you will have a number on it instead of 
your name. Only the researchers will know what your number is, and we will lock that information 
up with a lock and key. It will not be shared with or given to anyone except the PI’s of the study, 
the research nurse and the interventionists. The artwork created in the groups may be used in 
publications and presentations, however, these works will not be personally identified, and any 
personal information (ie, your name) will be edited out of the image before publication.  
 
Right to Refuse or Withdraw 
 You do not have to take part in this research if you do not wish to do so. You may also stop 
participating in the research at any time you choose. It is your choice and all your rights will still 
be respected. 
 
Alternatives to Participating 
If you do not wish to take part in the research, you will be provided with the established standard 
treatment available at the hospital. 
 
Who to Contact 
If you have any questions you may ask them now or later, even after the study has started. If you 
wish to ask questions later, you may contact any of the following: Johanna Czamanski-Cohen 
joczamanski@gmail.com, the research nurse _________________________. 
 

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14 OCT 2018 
This proposal has been reviewed and approved by the hospital Helsinki committee which is a 
committee whose task it is to make sure that research participants are protected from harm.  If 
you wish to find about more about the IRB, contact __________________________________. 
 
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask 
questions about it and any questions that I have asked have been answered to my satisfaction.  I 
consent voluntarily to participate as a participant in this research. 
 
 
 
Print Name of Participant__________________  
 
 
 
 
Signature of Participant ___________________ 
Date ___________________________ 
 
Day/month/year 
 
  
 
 
 
 
 
 
 
Print Name of Researcher taking the consent________________________ 
 
 
 
 
Signature of Researcher taking the consent__________________________ 
Date ___________________________ 
 
 
 
                 Day/month/year 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14 OCT 2018 
T0
-
DEMOGRAPHICS HEBREW
 
דמוגרפי 
 
אנא עני על השאלות הבאות .בשאלות שיש לצדן תשובה ,
 אנא
הקיפ
י את התשובה המיטיבה לתאר את מצבך .
 בשאלות שאין לצדן
אפשרות תשובה ,אנא השל
ימ
י בעצמך: 
 
 
גיל 
 
18
-
25
 
26
-
35
 
36
-
45
 
46
-
70
 
 מעל70
 
ארץ לידה 
 
  ישראל אחר_________
 
 
 
 
 מצב
משפחתי 
 
  רווק
ה 
 
  נשו
אה 
 
  גרוש
ה 
  אלמ
נה 
  אחר   :
 
 האם יש לך
ילדים?
 
 
  לא 
 
  כן 
 
 כמה ילדים יש
לך?
 
 
 
השכלה 
 
  תיכונית 
 
  לימודי תעודה 
 
  
 אקדמאית–
 
תואר ראשון 
  
 אקדמאית- 
 תארים
מתקדמים 
 
  אחר_______
 
 האם את
עובדת?
 
 
  לא 
 
כן 
 
 מקצוע/ 
 עיסוק
מרכזי: 
 
 
 
דת 
 
 
 
 
 
  יהודי
ה 
 
  מוסלמי
ת 
 
  נוצרי
ה 
 
  אחר__________
 
 
 
 כיצד היית
מגדיר
ה 
 את
 מידת
 הדתיות
שלך?
 
 
  חילוני
ת 
 
  ה דתי 
 
  מסורתי
ת 
 
  אחר_________
 
 
 
 האם את
 עוסקת
באמנות?
 
 
לא 
  כן ,באופן חובבני 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  כן ,
 באופן
מקצועי 
 
 

Study Product Guidelines and Considerations 
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Version 4.0 
 
 
14 OCT 2018 
 
T0
 
DEMOGRAPHICS ARABIC
 
 
 :فيما يلي عدة أسئلة, يرجى احاطة رقم اإلجابة ألصحيح وإكمال المعلومات الناقصة 
كم عمرك؟ 
18
-
25
 
26
-
35
 
36
-
45
 
46
-
70
 من فوق 
70
 
 
1.
 
 ارض:الوالدة 
 
اسرائيل 
 االتحاد
السوفييت
ي سابقا 
 
اثيوبيا اخر  
 
 
 
2.
 
:الوضع العائلي 
 
 متجوزة
  
ارمل/ة   
 مطلق/ة 
 
 مفصول/ة  
 
عازب/ة   
 
 
اخر
  
1.
 ه
ل لديك اوالد؟ 
 
ال نعم 
 
 
 
 
:هل تسكن في مدينة 
 قرية 
 
 مستوطنة 
 
________________اخر
  ___
 
 
 
1.
 
 ما هي
 درجتك
التعليمية
?
 
 
ثانوية اكاديمية- 
 طالب/ة
 او لقب
 اول  
اكاديمية- 
 لقب
 ثاني  
 اكاديمية– 
 لقب ثالث 
   
 
 
 اخر  
 
هل تعمل/ين؟ 
  نعم ال 
 
 
 
 
الوضع االقتصادي 
 اقل من
 الوسط  
 
 متوسط 
 
 اعلى من
 الوسط  
 
 
 
الديانة 
 يهودي/ة
 
 مسلم/ة  مسيحي/ة   درزي/ة 
 
اخر 
 
كيف تعرف نفسك؟ علماني/ة متدين/ة   ارثودوكسي/ة
  
 
تقليدي/ة   
 
اخر 
 
هل انخرطت في الفن؟ 
 
ال نعم ,
بطري ة
هواة 
 
 
  نعم ,مهنيا 
 
 
 
 
 
 
 
 
 
 
 
 

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14 OCT 2018 
 
T0
 
RR F Hebrew
-
PVQ
 
המשפטים הבאים מתארים בקצרה אנשים שונים .
 קראי בבקשה כל תיאור וחשבי עד כמה האדם הזה
דומה ,או לא דומה לך .
  סמניX
 
 בריבוע
משמאל המתאר עד כמה האדם המתואר דומה לך. 
 
 עד כמה אדם זה דומה לך?
 
 
 
 
 בכלל
 לא
 דומה
לי 
 לא דומה
לי 
 קצת
 דומה
לי 
 די
 דומה
לי 
 דומה
לי 
 מאד
 דומה
לי 
1.
 חשוב לה לעצב את השקפותיה באופן עצמאי .
 

 
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2.
 חשוב לה שהמדינה שלה תהיה בטוחה ויציבה. 
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3.
 
 חשוב לה
לבלות בנעימים .
 
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4.
 חשוב לה להימנע מלהרגיז אנשים אחרים. 
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5.
 
 חשוב לה שהחלשים והפגיעים בחברה יהיו
מוגנים. 

 
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6.
 
 חשוב לה שאנשים יעשו מה שהיא אומרת
שעליהם לעשות. 
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7.
 
 חשוב לה
לא 
 לראות את עצמה ראויה ליותר
מאחרים. 
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8.
 חשוב לה לשמור על הטבע .
 
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9.
 חשוב לה שאף אחד אף פעם לא יבייש אותה. 
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10
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 חשוב לה לחפש כל הזמן דברים שונים לעשות. 
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11
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 חשוב לה לדאוג לאנשים הקרובים אליה. 
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12
.
 
 חשוב לה שיהיה לה הכוח שכסף יכול להביא
איתו. 
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13
.
 
 חשוב לה מאוד להימנע ממחלות ולשמור על
בריאותה. 
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14
.
 
 חשוב לה להיות סובלני כלפי כל סוגי האנשים
והקבוצות. 
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15
.
 חשוב לה לעולם לא להפר חוקים או תקנות. 
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16
.
 
 חשוב לה לקבל בעצמה את החלטות שלה לגביי
חייו. 
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17
.
 חשוב לה שיהיו לה שאיפות בחיים. 
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18
.
 חשוב לה לשמר ערכים ודרכי חשיבה מסורתיים. 
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19
.
 
 חשוב לה שאנשים שהיא מכירה יתנו בה
אמון מלא.
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20
.
 חשוב לה להיות עשיר. 
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21
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 חשוב לה להשתתף בפעולות להגנה על הטבע. 
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22
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 חשוב לה לא לעצבן אף אחד אף פעם. 
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23
.
 חשוב לה לפתח דעות משלה. 
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Study Product Guidelines and Considerations 
45 of 79 
Version 4.0 
 
 
14 OCT 2018 
 עד כמה אדם זה דומה לך?
 
 
 
 
 בכלל
 לא
 דומה
לי 
 לא דומה
לי 
 קצת
 דומה
לי 
 די
 דומה
לי 
 דומה
לי 
 מאד
 דומה
לי 
24
.
 חשוב לה להגן על התדמית שלה בעיני אחרים .
 
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25
.
 מאד חשוב לה לעזור לאנשים היקרים לה .
 
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26
.
 חשוב לה להיות בטוחה ומוגנת באופן אישי. 
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27
.
 חשוב לה להיות חברה אמינה שניתן לבטוח בו .
 
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28
.
 חשוב לה לקחת 
 סיכונים שהופכים את החיים
למרגשים .
 
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29
.
 
 חשוב לה שיהיה לה הכוח לגרום לאנשים לעשות
מה שהיא רוצה. 
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30
.
 
 חשוב לה לתכנן את הפעילויות שלה באופן
עצמאי. 
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31
.
 
 חשוב לה לנהוג לפי החוקים גם כשאף אחד לא
מסתכל. 
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32
.
 
 חשוב לה להצליח מאוד
בחיים. 
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33
.
 
 חשוב לה לדבוק במנהגים משפחתיים או
במנהגים דתיים. 
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34
.
 
 חשוב לה להקשיב לאנשים השונים ממנה ולהבין
אותם. 
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35
.
 
 חשוב לה שמדינתה תהיה חזקה ומסוגלת להגן
על אזרחיה .
 
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36
.
 חשוב לה ליהנות מתענוגות החיים. 
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37
.
 
 חשוב לה שלכל אדם בעולם יהיו הזדמנויות שוות
בחיים. 
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38
.
 חשוב לה להיות ענוה .
 
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39
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 חשוב לה לפענח ולהבין דברים בעצמה. 
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40
.
 
 חשוב לה לכבד את המנהגים המסורתיים של
התרבות שלה. 
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41
.
  
 חשוב לה להיות זאת שאומרת לאחרים מה
לעשות. 
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42
.
 חשוב לה לציית לכל החוקים. 
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43
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 חשוב לה שיהיו לה כל מיני חוויות חדשות. 
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44
.
 
 חשוב לה שיהיו לה דברים יקרים המעידים על
עושרה. 
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45
.
 חשוב לה להגן על הטבע מהרס ומזיהום. 
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46
.
 חשוב לה לנצל כל הזדמנות ליהנות .
 
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47
.
 
 חשוב לה
לדאוג לכל צורך של יקיריה .
 
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48
.
 חשוב לה שאנשים יכירו בהישגים שלה. 
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49
.
 חשוב לה לעולם לא להיות מושפלת .
 
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Study Product Guidelines and Considerations 
46 of 79 
Version 4.0 
 
 
14 OCT 2018 
 עד כמה אדם זה דומה לך?
 
 
 
 
 בכלל
 לא
 דומה
לי 
 לא דומה
לי 
 קצת
 דומה
לי 
 די
 דומה
לי 
 דומה
לי 
 מאד
 דומה
לי 
50
.
 חשוב לה שמדינתה תגן על עצמה מפני כל איום. 
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51
.
 חשוב לה אף פעם לא להכעיס אנשים אחרים. 
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52
.
 
 חשוב לה שכולם
יקבלו יחס צודק ,
 גם אנשים
שאינה מכירה .
 
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53
.
 חשוב לה להימנע מכל דבר מסוכן. 
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54
.
 חשוב לה להסתפק במה שיש לה ולא לבקש יותר. 
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55
.
 
 חשוב לה שכל חבריה ובני משפחתה יוכלו לסמוך
עליה לחלוטין .
 
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56
.
 
 חשוב לה להיות חופשיה להחליט בעצמה מה היא
עושה. 
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57
.
 
 חשוב לה לקבל  אנשים אחרים גם כשאינה
מסכימה איתם. 
 
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Study Product Guidelines and Considerations 
47 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
T0
 
ARABIC
RR F 
-
PVQ
 
 גרסא1
 
 استبيان القِيَم الوصفية- 
(  النسخة العربيةPVQ-RR
()، إناث10
/
2013
)
 
فيما يلي نقدّم وصفاً مختصراً ألشخاص مختلفين. الرجاء قراءة كل وصف والتفكير 
 في مدى التشابه او االختالف بينك وبين
الشخص الموصوف.ثم نرجو وضع اشارةX 
 
 .في المربع الذي يشير إلى مدى التشابه بينك وبين الشخص الموصوف 
الى أي مدى تشبهك هذه الشخصية؟ 
 
 
 
 
 
 
 
 
 
 
 
 ال تشبهني
        أبدا 
   ال تشبهني
تشبهني 
 
         قليال
 تشبهني الى
         حد ما
تشبهني 
تشبهني
 كثيرا 
1
.
 من المهم لهاتكوين آرائها بشكل مستقل.
 
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2.
 
.ًمن المهم لها أن يكون وطنها آمناً ومستقرّا 
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3
.
 
.من المهم لها قضاء أوقات ممتعة 
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4
.
 
.من المهم لها أن تتجنّب مضايقة اآلخرين 
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5
.
 
 من.المهم لها أن تتم حمايةالضعفاء والمساكين والمهمشين في المجتمع
 
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6
.
 
.من المهم لهاأن يفعل األخرون ما تأمرهم بفعله 
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7
.
 
.من المهم لها أن ال تعتقد أبداً أنهاتستحق أكثر من اآلخرين 
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8
.
 
.من المهم لهاالمساهمة في حمايةالطبيعة 
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9
.
 
.من المهم لهاأالّ تتعرض أبداً لتشويه السُمعة من قبل أي شخص 
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10
. 
.من المهم لها البحث دائماً عنأشياءمختلفةللقيامبها 
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11
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.من المهم لها االهتمامباألشخاص المقرّبين إليها 
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12
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.من المهم لها امتالك القوة التي يمكن للمال أن يوفّرها 
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13
. 
.من المهم جدّاَ لهاأن تتجنّب األمراض وأن تحافظ على صحّتها 
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14
. 
.من المهم لها تقبّلكافّة نوعيات الناس والمجموعات السكانية 
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15
. 
.من المهم لها أن ال تُخالفأبداً القوانين والنُظُم 
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16
. 
 من المهم لها أن تتخذ قراراتها بنفسها بخصوص.حياتها 
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17
. 
.من المهم لهاأن تكون طَمُوحة في حياتها 
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18
. 
 من المهم لها الحفاظ على طرق التفكير والقيم المجتمعية
.التقليدية/المُحافِظة 
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19
. 
.من المهم لها أن يثق بها األشخاص الذين تعرفهم بصورة كاملة 
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Study Product Guidelines and Considerations 
48 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
 
 
 
 
 
 
 ال تشبهني
        أبدا 
   ال تشبهني
تشبهني 
 
         قليال
 تشبهني الى
         حد ما
تشبهني 
تشبهني
 كثيرا 
20
. 
 من المهم لها أن تكون.ًغنيّة 
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21
. 
.من المهم لها المشاركة بالفعاليات التي تهدف لحماية الطبيعة 
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22
. 
.من المهم لها االّ تُزعجأحدا 
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23
. 
.من المهم لها تطوير آرائها الشخصية 
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24
. 
.من المهم لها الدفاععن سمعتهاأمام الناس 
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25
. 
 من المهم جدّاً لها.أن تساعد االشخاص األعزاء بالنسبة لها 
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26
. 
.من المهم لهاأن تعيش بأمن وأمان 
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27
. 
.من المهم لها أن تكون صديقةً وفيةً ويمكن االعتمادعليها 
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28
.
 
.من المهم لها القيام بالمخاطراتالتي تجعل الحياة مشوّ قة 

 
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29
. 
 من المهم لها امتالك.القوة التي تمكّنها من إمالء إرادتها على اآلخرين 

 
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30
.
 
.من المهم لها التخطيط لنشاطاتها باستقاللية 

 
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31
. 
.من المهم لها االنصياع للقوانين حتى إن لم يكن أحد يراقبها 

 
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32
. 
.ًمن المهم لهاانتكونناجحةً جدا 
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33
.
 
 من المهم لها أن تتبع.عادات عائلتها أو تقاليد دينها 

 
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34
.
 
.من المهم لها االستماع إلى االشخاص المختلفين عنها وفهمهم 

 
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35
.
 
.من المهم لهاأن تكون الدولة قوية وقادرة على الدفاع عن مواطنيها 

 
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36
. 
.من المهم لها التمتّع بملذات الحياة 

 
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37
. 
 من المهم لها أن.تتوفر فرص متساويةلكل شخص في العالم 

 
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38
. 
.ًمن المهم لها أن تكون متواضعةً وزاهدة 

 
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39
. 
.من المهم لها أن تُدركاالشياء بنفسها 

 
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40
.
 
.من المهم لها احترام العادات والتقاليد الخاصة بمجتمعها 

 
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41
.
 
 من المهم لها أن تكون هي الشخص.الذييُخبر اآلخرين بما عليه فعله 

 
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42
. 
.من المهم لهاأن تطيع كافة القوانين 

 
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43
. 
.من المهم لهاأن تعيش تجارب جديدة بكافة اشكالها 

 

 

 

 

 

44
. 
.من المهم لهاأن تمتلك أشياء ثمينة تُظهر مدى ثرائها 

 

 

 

 

 


Study Product Guidelines and Considerations 
49 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
 
 
 
 
 
 
 ال تشبهني
        أبدا 
   ال تشبهني
تشبهني 
 
         قليال
 تشبهني الى
         حد ما
تشبهني 
تشبهني
 كثيرا 
45
. 
 من المهم لهاأن تتم حماية البيئة.الطبيعية من التدمير أو التلوث 

 

 

 

 

 

46
. 
.من المهم لهاأن تستغل كل فرصة لتُمضي وقتاً في االستمتاع 

 

 

 

 

 

47
. 
.من المهم لهاأن تعتني بكافة احتياجات األشخاص األعزاء على قلبها 

 

 

 

 

 

48
. 
.من المهم لهاأن يُالحظاآلخرون إنجازاتها 

 

 

 

 

 

49
. من المهم لهاأن 
.ًال تتعرض لإلهانة أبدا 

 

 

 

 

 

50
.
 
.من المهم لهاأن تحمي دولتهانفسها من كافة التهديدات 

 

 

 

 

 

51
. 
.ًمن المهم لها أن ال تُغضِ باآلخرين أبدا 

 

 

 

 

 

52
. من المهم لهاأن يحظى كل إنسان– حتى الذين ال تعرفهم– 
 بمعاملة
.عادلة 

 

 

 

 

 

53
. 
 من المهم لهاأن.تتجنّبأي شيء قد يعرضها للخطر 

 

 

 

 

 

54
. 
.من المهم لهاأن تكون قنوعةبما تملك وأن ال تطلب المزيد 

 

 

 

 

 

55
. 
 من المهم لهاأن يَقدِر جميع اصدقائها وأفراد أسرتهاعلى االعتماد عليها
.بشكل تام 

 

 

 

 

 

56
. 
.من المهم لها أن تكون حُرّةً في اختيار ما ترغب في فعله 

 

 

 

 

 

57
. 
.من المهم لها أن تتقبّل اآلخرين حتى وإن خالفتهم في الرأي 

 

 

 

 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Product Guidelines and Considerations 
50 of 79 
Version 4.0 
 
 
14 OCT 2018 
T2
, 
0, T1
T
 
 שאלון דיכאון10
-
R
-
CESD
 
HEB
 
למטה רשומים מספר דרכים שאולי הרגשת או התנהגת .אנא ספרי לנו באיזו תדירות הרגשת כך בשבוע האחרון. 
 
 
 
0
 =
 לעיתים
 רחוקות או
 בכלל לא(
 פחות
מיום אחד) 
 
1
 =
 חלק מהזמן
(
1
-
2 ימים) 
 
2
 =
 לעיתים או
 בצורה בינונית
(
3
-
4 ימים) 
 
3
 =
 חלק ניכר או
רוב הזמן (
5
-
7 
ימים) 
 
1.
 הפריעו לי דברים שבדרך כלל לא מפריעים לי 
0
 
1
 
2
 
3
 
2
 .היה לי קשה להתרכז במה שאני עושה 
0
 
1
 
2
 
3
 
3
 .הרגשתי מדוכאת 
0
 
1
 
2
 
3
 
4
 .הרגשתי שכל מה שאני עושה הוא מאמץ 
0
 
1
 
2
 
3
 
5
 .הרגשתי תקווה לגבי העתיד 
0
 
1
 
2
 
3
 
6
 .הרגשתי פחד 
0
 
1
 
2
 
3
 
7
 .השינה שלי היתה טרופה 
0
 
1
 
2
 
3
 
8
 .הרגשתי שמחה 
0
 
1
 
2
 
3
 
9
 .הרגשתי בודדה 
0
 
1
 
2
 
3
 
10
 .
 הרגשתי שאני לא מצליחה"להתניע"
 
0
 
1
 
2
 
3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Product Guidelines and Considerations 
51 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
10
-
R
-
CESD
 
T1, T2
T0, 
 
ARB
 
التعليمات:
 
.ضع دائرة على رقم محدد لكل عبارة تصف معدل شعورك أو سلوكك بهذه الطريقة خالل األسبوع الماضى 
 
 
 
:خالل األسبوع الماضى 
 ًنادراً أو أبدا 
 
 (أقل من يوم
)واحد 
 
 بعض الوقت أو
 ًقليال 
 
 (يوم إلى
)يومين 
 
 أحياناً أو قدر
 معتدل من
الوقت 
(
3
-
4 
)أيام 
 
 معظم أو كل  
الوقت 
 
 
(
5
-
7 
)أيام 
1
- 
 كنت أشعر بالضيق من أمور عادةً ال
تضايقنى 
0
 
1
 
2
 
3
 
2
-
 شعرت بصعوبة فى التركيز على ما أفعله 
0
 
1
 
2
 
3
 
3
-
 شعرت باالكتئاب 
0
 
1
 
2
 
3
 
4
-
 
 ًشعرت أن كل ما فعلته مجهدا 
0
 
1
 
2
 
3
 
5
-
 شعرت باألمل فى المستقبل 
0
 
1
 
2
 
3
 
6
-
 شعرت بالخوف 
0
 
1
 
2
 
3
 
7
-
 كان نومى مؤرق 
0
 
1
 
2
 
3
 
8
-
 
 ًكنت سعيدا 
0
 
1
 
2
 
3
 
9
-
 شعرت بالوحدة 
0
 
1
 
2
 
3
 
10
- ال استط "ع أن "أواصل 
0
 
1
 
2
 
3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Product Guidelines and Considerations 
52 of 79 
Version 4.0 
 
 
14 OCT 2018 
T0, T1, T2
 
FSI HEB
 
 בכל אחד מהמשפטים הבאים, הקיפי בעיגול את הספרה המתארת באופן  המדויק ביותר את
 .הרגשתך 
 
1.
 
 .מידת העיפות שלך ביום בו הרגשת הכי עייפה במהלך השבוע החולף 
 
 
 
0
       
1
       
2
      
3
       
4
       
5
       
6
      
7
        
8
      
9
       
10
 
לא עייפה                                                                          הכי עייפה 
                                                                          כלל         שאפשר 
 
 
2.
 
 .מידת העיפות שלך ביום בו הרגשת הכי  פחות עייפה במהלך השבוע 
 
 
0
      
1
       
2
       
3
       
4
      
5
       
6
      
7
       
8
       
9
       
10
 
לא עייפה                                                                    הכי עייפה 
כלל                                                                             שאפשר 
 
 
 
 
3.
 
 .מידת העיפות בממוצע לאורך השבוע האחרון 
 
                                                                                                                
     
 
 
0
       
1
       
2
       
3
      
4
       
5
       
6
      
7
       
8
       
9
       
10
 
לא עייפה                                                                                        הכי עייפה 
                                                           כלל                                  שאפשר 
4.
 
 .מידת העיפות שלך כרגע 
 
                                                                                                                     
 
 
0
      
1
       
2
      
3
       
4
       
5
      
6
       
7
       
8
      
9
        
10
 
לא עייפה                                                                           הכי עייפה שאפשר 
כלל 
 
 

Study Product Guidelines and Considerations 
53 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
 
 
 
5.
 
  .המידה בה  העיפות הפריעה לפעילות הכללית שלך בשבוע האחרון 
 
                                                       
                                                              
 
 
0
        
1
       
2
      
3
      
4
       
5
       
6
      
7
       
8
      
9
        
10
 
.לא הפריע כלל                                                                          הפרעה חזקה ביותר 
 
6.
 
   .המידה בה  העיפות הפריעה  ליכולתך להתקלח ולהתלבש בשבוע האחרון 
 
                                                                                                                     
 
 
0
      
1
       
2
      
3
       
4
       
5
      
6
       
7
     
   
8
        
9
        
10
 
.לא הפריע כלל                                                                         הפרעה חזקה ביותר 
 
7.
 
 עד כמה, במהלך השבוע האחרון העיפות הפריעה לפעילות העבודה הרגילה שלך (כולל
   .)עבודות מחוץ לבית וגם עבודות בית 
 
     
                                                                                                                
 
 
0
       
1
      
2
       
3
        
4
      
5
       
6
      
7
       
8
       
9
        
10
 
                                                לא הפריע כלל                          
.הפרעה חזקה ביותר 
 
 
8.
 
  .עד כמה, במהלך השבוע האחרון העיפות הפריעה ליכולת שלך להיות מרוכזת 
 
                                                                                                                     
 
 
0
      
1
  
    
2
        
3
      
4
       
5
       
6
       
7
      
8
       
9
      
10
 
.לא הפריע כלל                                                                     הפרעה חזקה ביותר 
 
9.
 
   .דרגי עד כמה, במהלך השבוע האחרון העיפות השפיעה על יחסיך עם אנשים אחרים 
 
                                                                                                                     
 
 
0
       
1
       
2
      
3
       
4
       
5
      
6
      
7
        
8
      
9
        
10
 

Study Product Guidelines and Considerations 
54 of 79 
Version 4.0 
 
 
14 OCT 2018 
                                           לא הפריע כלל                               
.הפרעה חזקה ביותר 
 
 
 
10
. 
   .עד כמה, במהלך השבוע האחרון העיפות הפריעה להנאה מחייך 
 
                                                                                                                     
 
 
0
      
1
     
   
2
       
3
      
4
       
5
       
6
      
7
        
8
      
9
        
10
 
.לא הפריע כלל                                                                          הפרעה חזקה ביותר 
 
 
11
. 
  .עד כמה, במהלך השבוע האחרון העיפות הפריעה לרמת הפעילות הכללית שלך 
 
                                                                                                                     
 
 
0
        
1
       
2
       
3
      
4
      
5
        
6
      
7
        
8
      
9
      
10
 
                                            לא הפריע כלל                            
.הפרעה חזקה ביותר 
 
 
12
. כמה ימים, במהלך השבוע האחרון חשת עייפו
ת 
   .בחלק כלשהו של היום 
 
                                                                                                                     
 
 
0
      
1
       
2
       
3
       
4
      
5
       
6
        
7
 
ימים                                                                 ימים 
 
                                                                 
 
13
. 
 צייני
איזה חלק מהיום 
 .בממוצע, חשת עייפות במהלך השבוע האחרון 
 
                                                                                                                     
 
 
0
        
1
       
2
       
3
       
4
      
5
       
6
      
7
        
8
      
9
        
10
 
                                                  כלל                         
.כל היום כולו 
                      לא 
 
 
 
 
 

Study Product Guidelines and Considerations 
55 of 79 
Version 4.0 
 
 
14 OCT 2018 
T0, T1, T2
 
FSI ARB
 
 
 
 ,بكل جملة من الجمل االتية
أ.حيطي بدائرة حول الرقم الذي يصف شعورك بدقة 
 
1
.
 
.)مستوى التعب الذي شعرتِ به في اليوم االكثر مُتعب خالل االسبوع الماضي(االخير 
 
                                   
 
          
 
         
0
       
1
       
2
      
3
       
4
       
5
       
6
      
7
        
8
      
9
       
10
  
 
     غير تعبة بالمرة                                                              
  متعبة جدا 
 
 
2
.
 مستوى تعبك في اليوم اال
قل تعبا  خالل االسبوع االخير 
 
 
 
          
0
      
1
       
2
       
3
       
4
      
5
       
6
      
7
       
8
       
9
       
10
 
 
                                                     غير تعبة بالمرة                 
     
  تعبة جدا 
 
3
.
 
 معدل مستوى التعب
خالل االسبوع االخير 
 
                                                                                                                     
 
 
         
0
       
1
       
2
       
3
      
4
       
5
       
6
      
7
       
8
       
9
       
10
 
 
     
                                          غير تعبة بالمرة                           
   
  تعبة جدا 
 
 
4
.
 مستوى تعبك االن 
 
                                                                                                                     
 
 
         
 
0
      
1
       
2
      
3
       
4
       
5
      
6
       
7
       
8
      
9
        
10
 
 
                                               غير تعبة بالمرة                          
  
  تعبة جدا 
 
 
5
.
 درجة تأثير التعب بشكل سلبي على نشاطك اليومي في االسبوع االخير 
 
 
                                                                                                                     
 
 
         
0
        
1
       
2
      
3
      
4
       
5
       
6
      
7
       
8
      
9
        
10
 
 
     لم يؤثر بالمرة                                                                       
  تأثير قوي جدا 
 

Study Product Guidelines and Considerations 
56 of 79 
Version 4.0 
 
 
14 OCT 2018 
6
.
 درجة تأثير التعب بشكل سلبي على قدرتك باالستحمام او اللبس باأل
سبوع االخير 
 
                                                                            
                                         
 
 
          
0
      
1
       
2
      
3
       
4
       
5
      
6
       
7
        
8
        
9
        
10
 
 
     
  لم يؤثر بالمرة                                                            تأثير قوي جدا 
 
 
 
7
.
 
 حتى اي (ألي) درجة أثر التعب بشكل سلبي على نشاط عملك المُعتاد خالل االسبوع االخير(يشمل
.)  العمل خارج البيت وداخل البيت ايضا   
 
 
                                                                                                                     
 
 
         
0
       
1
 
     
2
       
3
        
4
      
5
       
6
      
7
       
8
       
9
        
10
 
 
                                       لم يؤثر بالمرة                       
                
  تأثير قوي جدا 
 
 
 
8
.
 
 حتى اي (ألي) درجة أثر التعب بشكل سلبي على قدرتك في التركيز خالل االسبوع
االخير 
 
                                                                                                                     
 
 
          
0
      
1
      
2
        
3
      
4
       
5
       
6
       
7
      
8
       
9
      
10
 
 
 
            لم يؤثر بالمرة                                         
                       
  
  تأثير قوي جدا 
 
 
 
9
.
 حددي ,حتى اي درجة أثر التعب على عالقاتك مع االخرين خالل االسبوع االخير 
 
                                                                                        
                             
 
 
         
0
       
1
       
2
      
3
       
4
       
5
      
6
      
7
        
8
      
9
        
10
 
 
                                         لم يؤثر بالمرة                     
              
  تأثير قوي جدا 
 
 
 
10
. حتى اي درجة, أثر التعب بش
كل سلبي على متعتك بالحياة في االسبوع االخير   
 
 
                                                                                                                     
 
 
         
0
      
1
        
2
       
3
      
4
       
5
       
6
      
7
        
8
      
9
        
10
 
 

Study Product Guidelines and Considerations 
57 of 79 
Version 4.0 
 
 
14 OCT 2018 
                                                 لم يؤثر بالمرة                       
      
  تأثير قوي جدا 
 
 
 
 
11
. 
 حتى اي درجة, أثر التعب بشكل سلبي على مستوى نشاطك
العام في االسبوع االخير 
 
                                                                                                                     
 
 
        
0
        
1
       
2
       
3
      
4
      
5
        
6
      
7
        
8
      
9
      
10
 
 
لم يؤثر با                                                 لمرة                     
      
  تأثير قوي جدا 
 
 
 
12
. كم يوم من ايام االسبوع االخير شعرتِ مٌتعبة بجزء معين من اليوم 
 
                                                                                      
                               
 
 
        
0
      
1
       
2
       
3
       
4
      
5
       
6
        
7
        
 
         
                                         ايام         
     ايام 
 
                                                                 
 
13
. 
 حددي اية
جزء من اليوم بالمعدل
, شعرتِ تعبة خالل االسبوع االخير 
 
                                                                                                                     
 
 
        
0
        
1
       
2
       
3
       
4
      
5
       
6
      
7
        
8
      
9
        
10
 
 
         
                                                           بالمرة ال               اليوم كله 
                                                              
 
 
 
 
 
 
 
 
 
 
 
 
 
             
 

Study Product Guidelines and Considerations 
58 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
T0, T1, T2
 
HEB
 -
T
BCP
 
 
 
אנחנו מעוניינים לדעת עד כמה סבלת ב-
4 השבועות האחרונים מהבעיות המתוארות בטבלה .אנא סמנ י מספר
אחד בכל שורה .אם אין לך את הבעיה בכלל ,אז ציינ י"בכלל לא ."
 
במשך ארבעת השבועות האחרונים עד כמה הפריעו לך:
 
 
 באופן
קיצוני די הרבה 
 באופן
בינוני מעט בכלל לא 
 
4
 
3
 
2
 
1
 
0
 
1
  .גלי חום 
4
 
3
 
2
 
1
 
0
 
2
  .בחילה 
4
 
3
 
2
 
1
 
0
 
3
 .הקאות 
4
 
3
 
2
 
1
 
0
 
4
 .בריחת שתן בזמן צחוק או בכי 
4
 
3
 
2
 
1
 
0
 
5
 .
 בריחת שתן בזמן אחר 
4
 
3
 
2
 
1
 
0
 
6
 .יובש נרתיקי 
4
 
3
 
2
 
1
 
0
 
7
 .כאב בזמן יחסי מין 
4
 
3
 
2
 
1
 
0
 
8
 .כאבים כלליים בגוף 
4
 
3
 
2
 
1
 
0
 
9
 .כאבים בפרקים 
4
 
3
 
2
 
1
 
0
 
10
 .
 נוקשות בשרירים 
4
 
3
 
2
 
1
 
0
 
11
 .עלייה במשקל 
4
 
3
 
2
 
1
 
0
 
12
 .
 חוסר שביעות רצון ממראה גופי 
4
 
3
 
2
 
1
 
0
 
13
 .שכחנות 
4
 
3
 
2
 
1
 
0
 
14
 .הזעות לילה 
4
 
3
 
2
 
1
 
0
 
15
 .קושי להתרכז 
4
 
3
 
2
 
1
 
0
 
16
 .דעתי מוסחת בקלות 
4
 
3
 
2
 
1
 
0
 
17
 .
 נפיחות בזרוע(לימפדמה) 
4
 
3
 
2
 
1
 
0
 
18
 .
 מוגבלות בתווך התנועה של היד בצד של
הניתוח 
4
 
3
 
2
 
1
 
0
 
19
 .הפרשה מהנרתיק 
4
 
3
 
2
 
1
 
0
 
20
 .דימום מהנרתיק 
4
 
3
 
2
 
1
 
0
 
21
 .
 גירוד או גירוי באיברי המין(גניטלי) 
4
 
3
 
2
 
1
 
0
 
22
 .חוסר אנרגיה 
4
 
3
 
2
 
1
 
0
 
23
 .עייפות 
4
 
3
 
2
 
1
 
0
 
24
 .חוסר עניין ביחסי מין 
4
 
3
 
2
 
1
 
0
 
25
 .הנאה מועטה מיחסי מין 
 

Study Product Guidelines and Considerations 
59 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
T0, T1, T2
 
ARB
 
BCPT
 
 نريد أن نعرف مدى المعاناة التي تعرضت لها خالل
األسابيع األربعة الماضية 
 من المشكالت الموضحة في الجدول. يرجى
،وضع عالمة على رقم واحد في كل سطر. إذا لم تكن لديك المشكلة على اإلطالق فيمكنك اإلشارة إلى "ال على اإلطالق".
 
خالل األسابيع األربعة الماضية، ما مدى ازعاج كل من: 
 
بأقصى حد 
 
كثير جدا 
 
باعتدال 
 
 
قليل 
 
 
 ال على
االطالق 
 
 
4
 
3
 
2
 
1
 
0
 
1
  .موجات الحرارة 
4
 
3
 
2
 
1
 
0
 
2
  .غثيا 
4
 
3
 
2
 
1
 
0
 
3
 .قيء 
4
 
3
 
2
 
1
 
0
 
4
 .سلس البول أثناء الضحك أو البكاء 
4
 
3
 
2
 
1
 
0
 
5
 .سلس البول في وقت آخر 
4
 
3
 
2
 
1
 
0
 
6
 .جفاف المهبل 
4
 
3
 
2
 
1
 
0
 
7
 .ألم أثناء الجماع 
4
 
3
 
2
 
1
 
0
 
8
 .ألم عام في الجسم 
4
 
3
 
2
 
1
 
0
 
9
 .ألم في المفاصل 
4
 
3
 
2
 
1
 
0
 
10
 .تصلب العضالت 
4
 
3
 
2
 
1
 
0
 
11
 .زيادة بالوزن 
4
 
3
 
2
 
1
 
0
 
12
 .عدم الرضا عن مظهر جسدي 
4
 
3
 
2
 
1
 
0
 
13
 .نسيان 
4
 
3
 
2
 
1
 
0
 
14
 .التعرق الليلي 
4
 
3
 
2
 
1
 
0
 
15
 .صعوبة في التركيز 
4
 
3
 
2
 
1
 
0
 
16
 .ذهني يتشوش بسهولة 
4
 
3
 
2
 
1
 
0
 
17
 .
 تورم في الذراع(سرطان الغدد الليمفاوية)
 
4
 
3
 
2
 
1
 
0
 
18
 .صعوبة في حركة اليد من جهة الجراحة- 
 .العملية 
4
 
3
 
2
 
1
 
0
 
19
 .إفرازات مهبلية 
4
 
3
 
2
 
1
 
0
 
20
 .نزيف مهبلي 
4
 
3
 
2
 
1
 
0
 
21
 .الحكة التناسلية أو تهيج 
4
 
3
 
2
 
1
 
0
 
22
 .نقص القوى- الطاقة 
4
 
3
 
2
 
1
 
0
 
23
 .تعب-ارهاق 
4
 
3
 
2
 
1
 
0
 
24
 .عدم االهتمام بالعالقات الجنسية 
4
 
3
 
2
 
1
 
0
 
25
 .متعة قليلة من العالقة الجنسية 
 
 
 
 
 
 
 
 
 

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PROMIS HEB ARB 
 
T0, T1, T2
 
 
LEAS
 
T0, T1, T2
 
HEB
 
הנחיות למשתתפ/ת 
 כעת נתאר בפנייך מספר מצבים. אנא תאר/י כיצד להערכתך היית מרגיש/ה בכל אחד
 מהמצבים. את/ה יכול/ה לענות בתשובה קצרה או ארוכה, לפי מה שנחוץ לך על מנת לבטא
 .כיצד היית מרגיש/ה"הדרישה היחידה היא שתשתמש/י בתשובתך במילה "מרגיש/ה . בכל
 .אחד מהמצבים מוזכר אדם נוסף.תאר/י בבקשה גם מה את/ה חושב/ת שהאדם האחר ירגיש 
 
1. שכן/ה מבקש/ת ממך לתקן פריט ריהוט. ב
זמן השכן/ה מתבונן/ת, את מתחיל ה לדפוק
מסמר אבל מפספסת ופוגע .ת באצבעך 
כיצד א
ת מרגיש ?ה 
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כיצד השכן מרגיש ?
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2.
 את הול
כ ,ת במדבר עם מדריך/ה. אזלו לכם המים לפני שעות. לפי המפה של המדריך/ה
 .מקור המים הקרוב הוא בעוד שני ק"מ 
 ?כיצד את מרגישה
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?כיצד המדריך/ה מרגיש/ה 
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3.
 מישהו\מישהי אהוב\ה עו .שה לך עיסוי גב לאחר שחזרת מיום עבודה קשה 
 ?כיצד את מרגישה
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?כיצד האחר מרגיש 
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4. 
 .את משתתפת בתחרות ריצה יחד עם חבר/ה לאחר שהתאמנתם/ן יחד תקופה ארוכה
כאשר את קרוב ה לקו הסיום, את מעקמת את הקרסול, נופלת על האדמה, ואת לא
 .מסוגלת להמשיך 
 
?איך את מרגישה 
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?איך החבר/ה שלך מרגיש/ה 
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5. 
 .את מטיילת בארץ זרה. מכר/ה מעיר/ה הערה משפילה בנוגע לארץ המוצא שלך 
 ?כיצד את/ה מרגיש/ה
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?כיצד המכר/ה שלך מרגיש/ה 
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6.
 
 בעת שאת נוסעת על גשר חבלים, את רואה אדם עומד מעבר למעקה, מביט מטה
אל 
 .המים          
 ?כיצד את מרגישה
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?כיצד האדם האחר מרגיש 
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7.
 
 אהובך/תך שב/ה הביתה לאחר מספר שבועות. כשהוא/היא פותח/ת את הדלת... כיצד
את 
 ?מרגישה
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?כיצד אהובך/תך מרגיש/ה 
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8. 
 המנהל/ת אומר/ת לך שהעבודה שלך לא מספיק טובה ושעלייך להשתפר. כיצד את
?מרגישה 
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?כיצד המנהל/ת מרגיש/ה 
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9.
 את עומדת בתור בבנק. האדם לפניך ניגש לדלפק ומתחיל בעסקה מורכבת 
 שצפויה
להמשך זמן רב
. כיצד את מרגיש
ה ?
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?כיצד האדם לפניך מרגיש 
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. 
 .את ובן/בת הזוג שלך נוסעים הביתה מערב בילוי עם חברים כשאתם פונים לרחוב
?מגוריכם את רואה רכבי כיבוי אש ליד ביתכם. כיצד את מרגישה 
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?כיצד בן/בת הזוג מרגיש/ה 
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11
.  ע בדת קשה על פרויקט במשך מספר חודשים. מספר ימים לאחר הגשתו, המנהל/ת
 .עובר/ת ואומר/ת לך שעשית עבודה מצוינת 
 ?כיצד את מרגישה
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?כיצד המנהל/ת שלך מרגיש/ה 
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12
.  
 .את מקבלת שיחת טלפון לא צפויה מרופא/ה המודיע/ה לך שאמך נפטרה 
כיצד את מרגישה? 
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?כיצד הרופא/ה מרגיש/ה 
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13
.  
 את אומרת לחבר/ה שחש/ה בודד/ה שהוא/היא יכול/ה להתקשר אליך בכל זמן
שהוא/היא 
.חש/ה צורך לדבר. הוא/היא מתקשר/ת אליך בארבע לפנות בוקר 
 ?כיצד את מרגישה
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?כיצד החבר/ה שלך מרגיש/ה 
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14
. 
 .רופא/ת השיניים אומר/ת לך שיש לך מספר חורים וקובע לך תור נוסף 
 
 ?כיצד את מרגישה
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?כיצד רופא/ת השיניים מרגיש/ה 
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15
. 
 .אדם שהיה ביקורתי כלפיך בעבר נותן לך מחמאה 
 ?כיצד את מרגישה
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?כיצד האדם האחר מרגיש 
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16
. 
 הרופא אמר כי עליך להימנע מאוכל שמן. חבר/ה חדש/ה בעבודה מתקשר/ת להגיד
 .שהוא/היא יוצא/ת לאכול פיצה ומזמין/ה אותך להצטרף 
 ?כיצד את מרגישה
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?כיצד החבר/ה מרגיש/ה 
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17
. 
 את וחבר/ה מחליטים להשקיע יחד כסף על מנת להתחיל עסק חדש. מספר ימים לאחר
 .מכן, את מתקשרת לחבר/ה ומגלה שהוא/היא שינה/תה את דעתו/ה 
 ?כיצד את מרגישה
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?כיצד החבר/ה מרגיש/ה 
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18
. 
 את מוכרת פריט אהוב עליך על מנת לקנות מתנה יקרת ערך לבן/בת הזוג שלך. כשאת
 מעניקה לו/לה את המתנה הוא/היא שואל/ת האם מכרת את הפריט
יקר ה
ערך .
 
 
 ?כיצד את מרגישה
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?כיצד בן/בת הזוג מרגיש/ה 
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19
. 
 את מתאהבת במישהו/י גם מושכ/ת וגם חכמ/ה.  לא אכפת לך שמצבו/ה הפיננסי לא
 טוב, הכנסתך מספקת. כשאתם מתחילים לדבר על חתונה, את/ה מגלה שהוא/היא
בעצם מגיע/ה ממשפחה מאוד עשירה. הוא/היא לא רצה/תה שהדבר יתגלה מתו ך חשש
 .שיתעניינו בו/ה רק בגלל הכסף 
 ?כיצד את מרגישה
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כ?יצד הוא/היא מרגיש/ה 
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20
. 
 את וחברך/תך הטוב/ה ביותר עוסקים באותו תחום עבודה. יש פרס שנתי שניתן עבור
 הביצועים הטובים ביותר. שניכם/שתיכן עבדתם/ן קשה עבור הפרס. ערב אחד מכריזים
על הזו .כה: ...החבר/ה שלך 
כיצד את מרגיש
ה ?
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?כיצד החבר/ה שלך מרגיש/ה 
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LEAS ARB
 
 
:ألتعليمات 
 .من فضلك اوصف/ي ماذا سيكون شعورك في هذه الحاالت. الشرط الوحيد هو أن تستعمل/ي كلمة "أشعر" في اجاباتك 
 .بإمكانك أن تختصر/ي او تطيل/ي باإلجابة طالما كان ذلك ضروريا للتعبير عن كيفية شعورك 
 في كل حالة, هناك شخص
آخر 
 .مذكور. يرجى أن توضح/ي ماذا تعتقد/ين انه سوف يشعر ايضا 
 
1.
 يطلب\تطلب منك أحد الجيران\ت أن تصلح/ي له قطعة من األثاث. وعندما كان\
 ت هو\هي ينظر\تنظر إلي ك
بدأت/ي بدق المسمار ولكنك اضعته وضربت/ي اصبعك. كيف سيكون شعورك؟ وكيف سيشعر\
 ستشعر
الجار\
 الجارة؟ 
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2.  بعد عودتك من ي وم شاق في العمل شخص مقرب محب يأتي ليدلك لك ظهرك. كيف سيكون شعورك؟ وكيف
سيشعر هذا الشخص؟ 
 
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3 . وأنت تقود\ي السيارة ع لى جسر معلق, هناك شخص يقف بالجانب االخر من الدرابزين وينظر الى الماء في
 األسفل, كيف سيكون شعورك؟ وكيف سيكون شعور الشخص؟ 
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4
 . رئيسك/رئيستك في العمل يخبرك بأن عملك كان غير مقبول ويحتاج الى تحسين. كيف سيكون شعورك؟ وكيف
سيكون شعوره\
 ا؟ 
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5.  وأنت تقف لتنتظر\
 ي دورك في البنك. الشخص الذي أمامك يتقدم الى الشباك ويبدأ بمعاملة معقدة جدا. كيف
سيكون شعورك؟ ك يف سيكون شعور الشخص الذي أمامك؟ 

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6. كنت قد عملت بجد على مشروع لعدة اشهر. بعد عدة أيام من تقديمه, رئيسك\رئيستك في ا
لعمل يقف\
 تقف
ليخبرك\لتخبرك بأن عملك كان ممتازا. كيف سيكون شعورك؟ كيف سيكون شعور رئيسك\
 رئيستك؟  
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7. يخبرك\تخبرك طبي
ب\ة األسنان بأن لديك عدة تجاويف ويعين\
 تعين لك موعد لزيارة قادمة. كيف سيكون شعورك؟
كيف سيكون شعور طبيب\
 ة األسنان؟ 
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8. أخبرك\أخبرتك طبيبك\
 طبيبتك بتجنب األطعمة الدهنية. زميلك/زميلتك الجديد/ة في العمل يدعوك/تدعوك لتناول
 البيتزا. كيف سيكون شعورك؟ كيف سيكون شعور زميلك/زميلتك؟ 
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9
 . أنت وصديق/ة تتفقان الستثمار المال معا للبدأ بمشروع تجاري جديد. بعد عدة أيام تتصل به/ا لتعلم بأنه/ا غير/ت
رأيه/ا. كيف سيكون شعورك؟ كيف سيشعر صديقك؟ 
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10. وقعت\ي بالحب مع  احداهن\
 احدهم بشخصية جذابة وذكية. على الرغم من ان هذا الشخص حالته/ا المادية ليست
جيدة, هذا ليس مهم بالنسبة لك—فدخلك كاف. عندما تبدءوا بالحديث عن الزواج تعلم 
 .بأنه/ا من عائلة غنية للغاية
وهو\
 هي لم يخبرك/تخبرك بسبب مخاوفه/ا بأن الناس سوف يهتمون به/ا ألجل ماله/ا. كيف سيكون شعورك؟ كيف
سيشعر\ستشعر هو\
 هي؟ 

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11
 . انت تمشي في الصحراء مع مرشد. نفذت معكم المياه من قبل ساعة. حسب خارطة المرشد اقرب بئر يبعد عنكم
3 
 كيلومتر. كيف سيكون شعورك؟ كيف سيكون شعور المرشد؟ 
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12. انت تركض\ين في سباق مع صديق/ة تدربت معه/ا لبعض الوقت. وانت تقترب\
 ين من خط النهاية, يلتوي
كاحلك, وتسقط على األ
رض, وال تقدر على االستمرار. كيف سيكون شعورك؟ كيف سيكون شعور صديقك/صديقتك؟ 
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13. انت مسافر\ة في بلد اجنبي. شخص من احد معارفك يقول\
 تقول تصريحات مهينة لبلدك األصلي. كيف سيكون
 شعورك؟ كيف سيشعر الشخص؟ 
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_____________________________________________________________________
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14
 . حبيبك/حبيبتك ذهب/ت لعدة أسابيع واخيرا اتى/اتت الى المنزل. وهو/وهي يفتح/تفتح الباب...كيف سيكون
شعورك؟ كيف سيكون شعوره/ا؟ 
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
___________________________________________________
 
 
15
. 
 انت وزوجك/زوجتك رجعتم في السيارة الى المنزل بعد سهرة مع األصدقاء, وعند اقترابكم من حيكم ترون
 سيارات
اطفاء مصطفه بالقرب من منزلكم. كيف سيكون شعورك؟ كيف سيكون شعور زوجك/زوجتك؟ 

Study Product Guidelines and Considerations 
72 of 79 
Version 4.0 
 
 
14 OCT 2018 
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16. تتلقى\تتلقي مكالمة هاتفية غير متوقعة بعيدة المدى من طبيب\ة يخبرك\
 تخبرك بأن امك قد توفت. كيف ستشعر؟
كيف سيشعر الطبيب\
 ة؟ 
_____________________________________________________________________
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17. تخبر صديقك/صديقتك الذي/الت ي يشعر/تشعر بالوحدة انه/ا بإمكانه/ا االتصال بك بأي وقت هو/هي يحتاج/تحتاج
 الى التحدث. في احدى الليالي يتصل/تتصل بك الساعة الرابعة قبل الفجر. كيف ستشعر؟ كيف سيشعر/ستشعر
صديقك/صديقتك؟ 
_____________________________________________________________________
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_____________________________________________________________________
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_____________________________________________________________________
___________________________________________________
 
 
18. احدهم\احدهن كان/ت ينتقدك/تنتقدك في الماضي, يقدم/تقدم لك اطراء. كيف ستشعر؟ كيف سيشعر الشخص؟ 
_____________________________________________________________________
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___________________________________________________
 
 
19. تبيع\
 ين شيء غالي عليك من ممتلكاتك لكي تشتري هدية ثمينة لزوجتك/زوجك. عندما تعطيها/تعطيه اياها
تسألك/يسألك ان كن ت قد بعت غرض لك. كيف ستشعر؟ كيف ستشعر/سيشعر
زوجتك/زوجك؟______________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
______________________________________________
 
20. انت وصديقك/صديقتك المفضل/ة في نفس خط العمل. هناك جائزة 
 سنوية تقدم ألفضل اداء للسنة. كالكما عملتما
 جاهدا للفوز بالجائزة. في احد الليالي اعلنوا عن الفائز: صديقك/صديقتك. كيف ستشعر؟ كيف سيشعر/ستشعر
صديقك/صديقتك؟ 
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Study Product Guidelines and Considerations 
73 of 79 
Version 4.0 
 
 
14 OCT 2018 
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Study Product Guidelines and Considerations 
74 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
COPE EAC HEB T0, T1, T2
 
אנא קראי כל משפט ,והעריכי באיזו מידה הנך משתמש/
 ת בכל דרך התמודדות
עם חווית סרטן השד  בארבעת השבועות האחרונים :
 
 
 
 אני לא
 עושה
זאת 
 אני
 עושה
 זאת
מעט 
 אני
 עושה
 שזאת
 במידה
בינונית
 אני
 עושה
 זאת
 לעיתים
קרובות 
 מסרבת
לענות 
1.
 אני לומדת משהו מההתנסות עם המצב 
1
 
2
 
3
 
4
 
8
 
2.
 
 אני לוקחת
זמן להבין איך אני באמת מרגישה 
1
 
2
 
3
 
4
 
8
 
3.
 אני מרכז
ת את כוחותיי כדי לעשות משהו 
1
 
2
 
3
 
4
 
8
 
4.
 אני מודה בפני עצמי שאיני יכול/ה לטפל במצב ומפסיק/ה לנסות 
1
 
2
 
3
 
4
 
8
 
5.
 אני משלי
מ
ה עם העובדה שזה קרה ושזה לא ניתן לשינוי 
1
 
2
 
3
 
4
 
8
 
6.
 אני מנסה להתייע
ץ 
 עם מישהו לגבי מה כדאי לעשות 
1
 
2
 
3
 
4
 
8
 
7.
 אני קובעת תכנית פעולה 
1
 
2
 
3
 
4
 
8
 
8.
 אני מעמיקה ברגשותיי כדי להבין אותן בצורה יסודית 
1
 
2
 
3
 
4
 
8
 
9.
 אני פועלת כדי לשפר את המצב 
1
 
2
 
3
 
4
 
8
 
10
. אני מתנהגת כאילו זה כלל לא קרה 
1
 
2
 
3
 
4
 
8
 
11
. אני מנסה לקבל עזרה ויעוץ מאחרים 
1
 
2
 
3
 
4
 
8
 
12
. 
 אני אומרת לעצמי ש "
 זה לא באמת"
 
1
 
2
 
3
 
4
 
8
 
13
. אני לוקחת זמן כדי לבטא את רגשותיי 
1
 
2
 
3
 
4
 
8
 
14
. אני מעמידה פנים כאילו זה לא קרה 
1
 
2
 
3
 
4
 
8
 
15
. אני לומדת לחיות עם זה 
1
 
2
 
3
 
4
 
8
 
16
. אני חושבת הרבה על הצעדים שעלי לנקוט 
1
 
2
 
3
 
4
 
8
 
17
. אני מרשה לעצמי להביע את רגשותיי 
1
 
2
 
3
 
4
 
8
 
18
. 
  אני מנסה לראות את הדברים באור חיובי יותר 
1
 
2
 
3
 
4
 
8
 
19
. אני מקבלת נחמה והבנה ממישהו 
1
 
2
 
3
 
4
 
8
 
20
. א
ני מחפש/ת משהו טוב בדברים שקרו 
1
 
2
 
3
 
4
 
8
 
21
. אני מרגישה  חופשיה להביע את רגשותיי 
1
 
2
 
3
 
4
 
8
 
22
. אני מקבלת תמיכה רגשית מאחרים 
1
 
2
 
3
 
4
 
8
 
23
. אני מסרב/ת להאמין שזה קרה 
1
 
2
 
3
 
4
 
8
 
24
. אני מתרגלת לרעיון שזה קרה 
1
 
2
 
3
 
4
 
8
 
25
. אני מרגישה שהרגשות שלי תקפים וחשובים 
1
 
2
 
3
 
4
 
8
 
26
. אני חולמת בהקיץ על דברים אחרים 
1
 
2
 
3
 
4
 
8
 
27
. אני מוותרת על הניסיון להתמודד עם זה 
1
 
2
 
3
 
4
 
8
 
28
. אני פונה לפעילויות חלופיות כדי להסיח את דעתי מהמצב 
1
 
2
 
3
 
4
 
8
 
29
. אני מדבר/
 ת על
רגשותיי בחופשיות 
1
 
2
 
3
 
4
 
8
 
30
. אני מוותרת על הניסיון להתמודד 
1
 
2
 
3
 
4
 
8
 
31
. אני ישנה יותר מבדרך כלל כדי לחשוב על זה פחות 
1
 
2
 
3
 
4
 
8
 
32
. אני מכירה ברגשותיי 
1
 
2
 
3
 
4
 
8
 
33
. אני מנסה לצמוח כאדם כתוצאה מהחוויה 
1
 
2
 
3
 
4
 
8
 
34
. אני מפחיתה את כמות המאמצים שאני משקיעה בהתמודדות 
1
 
2
 
3
 
4
 
8
 
35
. אני פונה לעבודה או פעילויות אחרות כדי להסיח את דעתי 
1
 
2
 
3
 
4
 
8
 
36
. אני מקבלת את זה שזה מה שקרה וזה לא ניתן לשינוי 
1
 
2
 
3
 
4
 
8
 

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75 of 79 
Version 4.0 
 
 
14 OCT 2018 
 

Study Product Guidelines and Considerations 
76 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
T0, T1, T2
  
COPE ARB
 
 خالل.األسابيع األربعة الماضية: لطفاً، اقرئي كل جملة وحاولي تقييم درجة استعمالك لكل طريقة تأقلم مع تجربة سرطان الثدي 
 
 
 ال أفعل
هذا 
 أفعل هذا
 بشكل
قليل 
 أفعل
 هذا
 بشكل
معتدل 
 أفعل هذا
 بشكل
كبير 
 أرفض
اإلجابة 
1.
 
.أنا اتعلم من تجربتي مع الوضع 
1
 
2
 
3
 
4
 
8
 
2.
 
 اَخذ بعض الوقت.لكي افهم ماذا اشعر بالفعل 
1
 
2
 
3
 
4
 
8
 
3.
 
.ارّكز كل طاقاتي لكي انفذ امر معين 
1
 
2
 
3
 
4
 
8
 
4.
 
 أنا اعترف لنفسي بأنني ال أستطيع ان اتعامل مع الموقف وأتوقف عن
.المحاولة 
1
 
2
 
3
 
4
 
8
 
5.
 
.أنا اقبل حقيقة أن األمر حدث وال يمكن تغييره 
1
 
2
 
3
 
4
 
8
 
6.
 
 أحاول استشارة شخص ما حول ما يجب.علي فعله 
1
 
2
 
3
 
4
 
8
 
7.
 
.أنا اضع خطة عمل 
1
 
2
 
3
 
4
 
8
 
8.
 
.ًأنا اتعمق بمشاعري لكي افهمها جيدا 
1
 
2
 
3
 
4
 
8
 
9.
 
.انا اعمل لكي أُحسن الوضع 
1
 
2
 
3
 
4
 
8
 
10
. 
.ًأنا اتصرف كأن االمر لم يحدث ابدا 
1
 
2
 
3
 
4
 
8
 
11
. 
.أحاول ان اتلقى مساعدة وإستشارة من االَخرين 
1
 
2
 
3
 
4
 
8
 
12
. 
 أقول لنفسي أن " هذا."غير صحيح 
1
 
2
 
3
 
4
 
8
 
13
. اَخذ 
.بعض الوقت لكي اعبر عن مشاعري 
1
 
2
 
3
 
4
 
8
 
14
. 
.اتظاهر كأن األمر لم يحصل 
1
 
2
 
3
 
4
 
8
 
15
. 
.اتعلم ان اتعايش مع األمر 
1
 
2
 
3
 
4
 
8
 
16
. 
.افكر كثيرا حول الخطوات التي يتوجب علي اتخاذها 
1
 
2
 
3
 
4
 
8
 
17
. 
.اسمح لنفسي ان اعبر عن مشاعري 
1
 
2
 
3
 
4
 
8
 
18
. 
 أحاول ان أرى
األمور 
.بصورة إيجابية أكثر 
1
 
2
 
3
 
4
 
8
 
19
. احصل على الراحة- التفهم واالحتواء من شخص ما. 
1
 
2
 
3
 
4
 
8
 
20
. ابحث عن امر جيد باألمور التي 
.حصلت 
1
 
2
 
3
 
4
 
8
 
21
. اشعر بحرية التعبير عن 
.مشاعري 
1
 
2
 
3
 
4
 
8
 
22
. احصل علي دعم عاطفي من االخرين. 
1
 
2
 
3
 
4
 
8
 
23
. ارفض التصديق بان هذا حصل. 
1
 
2
 
3
 
4
 
8
 
24
. اعتدت على فكرة ان االمر قد حصل. 
1
 
2
 
3
 
4
 
8
 
25
. انا اشعر بان مشاعري صحيحة-مالئمة ومهمة. 
1
 
2
 
3
 
4
 
8
 
26
. احلم بان استيقظ على امور اخرى. 
1
 
2
 
3
 
4
 
8
 
27
. اتخلى عن محاولة التعامل- 
.االعتياد مع هذا االمر 
1
 
2
 
3
 
4
 
8
 
28
. اتوجه لفعاليات وانشطة 
 بديلة لصرف نفسي–الهي نفسي عن الوضع. 
1
 
2
 
3
 
4
 
8
 
29
. انا اتحدث عن مشاعري بحرية. 
1
 
2
 
3
 
4
 
8
 
30
. 
.اتخلى عن محاولة التأقلم 
1
 
2
 
3
 
4
 
8
 
31
. انام لوقت اطول من المعتاد لكي افكر باالمر اقل. 
1
 
2
 
3
 
4
 
8
 
32
. أنا أعي-اعرف مشاعري .
 
1
 
2
 
3
 
4
 
8
 
33
. احاول ان أنضج وانمو من هذه التجربة. 
1
 
2
 
3
 
4
 
8
 
34
. أقوم بتقليل المجهود الذي 
 ابذله.واستثمره في التأقلم 
1
 
2
 
3
 
4
 
8
 
35
. اتوجه للعمل او فعالية اخرى لكي اشغل واصرف تفكيري بأمور 
اخرى. 
1
 
2
 
3
 
4
 
8
 
36
. 
 اتقبل االمر.بأن هذا ما حدث وال يمكن تغييره 
1
 
2
 
3
 
4
 
8
 

Study Product Guidelines and Considerations 
77 of 79 
Version 4.0 
 
 
14 OCT 2018 
שאלון קבלה רגשיתT0 T1 T2 
אנא ציינ י (על ידי הקפה בעיגול )
 עד כמה כל הצהרה מתארת את יחסך לרגשותייך
בצורה מיטבית .
0
 =
 בכלל
לא כמוני ;
100
 =בדיוק כמוני .
 
 
1.
  אני מנס
ה להבין בדיוק מה קורה עם הרגשות שלי ,מכיוון  שאני רוצה לעזור לעצמי 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
2.
 נוח לי עם רגשותיי כפי שהם ,
 למרות שאני יודעת שאינם"מושלמים"
 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
3.
 אני נותנת לעצמי להרגיש שמחה ושבע
ת רצון עם רגשותיי ,בדיוק כפי שהם 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
4.
 אני עובדת ומתאמנת על פיתוח רגשות בעלי ערך 
 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
5.
 אני מוק
יר
ה את רגשותיי בצורה רכה ואוהבת 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
6.
 אני מתייחס
ת לרגשותיי בקלות 
 ובאופן טבעי 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
7.
 
 אני מאוד
נהני
ת מהרגשות שלי 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
8.
 אני מעריכ
ה את רגשותיי ,בצורה עדינה וחמה ,
 בדיוק כפי שהם 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
9.
 אני משחררת בנוחות את רגשותיי מכיוון שהם משקפים את העצמי הפנימי והעמוק 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
10
. אני מטפלת ושמ
ה לב לרגשותיי בנוחות 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
11
.  אני משקיע
ה הרבה כוחות בלהבין את רגשותיי ולבחור איך להתמודד איתן 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
12
. אני מבינה ומחבב
ת את רגשותיי בדיוק כפי שהן 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
13
.  אני מרשה לעצמי להיות מחובר ת לרגשותיי מכיוון שזה טוב עבורי 
 
0    10   20   30   40   50   60   70   80    90    100
 

Study Product Guidelines and Considerations 
78 of 79 
Version 4.0 
 
 
14 OCT 2018 
 
 
 
 TO,T1,T2 שאלון קבלה רגשית ערבית 
 ،ًلطفا ِأحيط 
 بدائرة الى أي
مدى تصف 
 كل
عبارة عالقتك بمشاعرك 
  بأفضل شكل  .
0
 = ال يمثلني على االطالق؛100
 = يمثلني
.تماما 
1.
  أحاول أن أفهم بالضبط ماذا يح
دث مع 
،مشاعري بحيث أريد أن أساعد نفسي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
2.
 انا مرتاحة مع مشاعري كما هي، على الرغم 
"من انني اعي بانها غير "مثالية 
0    10   20   30   40   50   60   70   80    90    100
 
 
3.
 اعطي نفسي ان اشعر بالسعادة والرض
ا مع 
،مشاعري بالضبط كما هي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
4.
 انا اعمل واتمرن على تطوير مشاعر ذات قيمة. 
 
0    10   20   30   40   50   60   70   80    90    100
 
 
5.
 عتز ا بم
شاعري بشكل لطيف ومحب. 
0    10   20   30   40   50   60   70   80    90    100
 
 
6.
 اتعامل مع مشاعري ببساطة وبشكل طبيعي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
7.
 انا استمتع 
 ًكثيرا من مشاعري. 
0    10   20   30   40   50   60   70   80    90    100
 
 
8.
 انا اقدّر 
،مشاعري بشكل لطيف ودافئ، تماما كما هي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
9.
 انا أطلق مشاعري بكل راحة من منطلق بانها تعكس حقيقتي ونفسيتي بشكل عميق. 
0    10   20   30   40   50   60   70   80    90    100
 
 
10
. انا اعتني وانتبه لمشاعري ب
شكل مريح. 
0    10   20   30   40   50   60   70   80    90    100
 
 
11
.  ابذل طاقات كبيرة لكي افهم مشاعري واختار كيف اتعامل معها. 
0    10   20   30   40   50   60   70   80    90    100
 
 
12
. انا افهم واحب مشاعري واجدها مناسبة تماما كما هي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
13
. اسمح لنفسي بالتواصل مع مشاعري ه ألن جيد بالنسبة لي. 
0    10   20   30   40   50   60   70   80    90    100
 
 
 
 
 

Study Product Guidelines and Considerations 
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Version 4.0 
 
 
14 OCT 2018