Pain Acceptance Training in Patients Experiencing Emotional Distress and Somatic Symptoms: Examination of Dialectical Thinking as a Mediating Factor
Phase: NA
Conditions: Chronic Pain, Somatic Pain, Comorbid Pain and Emotional Difficulties
Sponsor: University of Haifa

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Research Protocol 
 
Research Title:  
Pain Acceptance Training in Patients Experiencing Emotional Distress and Somatic Symptoms: 
Examination of Dialectical Thinking as a Mediating Factor 
 
Hebrew Title:  
חשיבה דיאלקטית כמתווכת את יעילות אימון קבלה לכאב ב מטופלים עם מצוקה נפשית ותסמינים
סומטיים  
 
 
Protocol number: 0062-24, v.1.5, Date: 12.05.2025 
 
PI: Dr. Shulamit Grinapol  
 
Sub-Investigators: Dr. Itai Horowitz, Dr. Haya Yaron-Wachtel, Dr. Amir Minerbi  
 
External Co-Investigators:  
Prof. Irit Weissman-Fogel, Faculty of Social Welfare and Health Sciences, University of Haifa. 
Prof. Hadas Okon-Singer, School of Psychological Sciences, University of Haifa. 
Einav Gozansky, PhD student, School of Psychological Sciences, University of Haifa. 
 
 
 
 
 
 
 
CONFIDENTIAL
 
The information in this document is considered privileged and confidential and may not be disclosed to others except to the 
extent necessary to obtain Institutional Review Board/Ethics Committee approval, informed consent and the approval of local 
regulatory authorities as required by local law.
 
  

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STUDY SYNOPSIS 
Somatic symptoms, including physical pain, are highly prevalent among mental health patients. 
Current treatments have limited effectiveness for these symptoms, primarily because of patients’ 
diminished introspective capacity and lack of emotional awareness. The current study proposes 
pain acceptance training as a new intervention. This intervention relies on the tenets of dialectical 
thinking, particularly on maintaining a dialectic perspective – at once acknowledging both the 
desire to end the pain and the ability to accept it as it is. We aim to examine the following: (1) the 
efficacy of pain acceptance training in the alleviation of somatic pain in patients with somatic 
symptoms; (2) the role of dialectical thinking as a mediator of pain acceptance training efficacy. 
 
LIST OF ABBREVIATIONS 
DBT = Dialectical Behavior Therapy. 
CPT = Cold Pressor Task. 
 
 

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STUDY AIMS  
Somatic symptoms, including physical pain, are highly prevalent among mental health 
patients. Current treatments have limited effectiveness for these symptoms, primarily because of 
patients diminished introspective capacity and lack of emotional awareness. The current study 
proposes pain acceptance training as a new intervention. This intervention relies on the tenets of 
dialectical thinking, and particularly on maintaining a dialectic perspective – at once 
acknowledging both the desire to end the pain and the ability to accept it as it is. Our aims are to 
examine the following: (1) the efficacy of pain acceptance training in alleviation of somatic pain 
in patients with somatic symptoms; (2) the role of dialectical thinking as a mediator of pain 
acceptance training efficacy. 
 
BACKGROUND 
Somatic symptom disorders are among the most common mental disorders, with an 
estimated prevalence of 5-7% in the general population1. Somatic disorders are characterized by 
persistent, unexplained physical symptoms, such as pain and gastrointestinal and cardiovascular 
symptoms, which cause significant impairments to regular functioning and high burden due to 
multiple medical consultations2,3. A substantial proportion of patients also experience comorbid 
depression and anxiety3,4,5. 
Growing evidence indicates that specific maladaptive psychological factors (e.g., 
catastrophizing, emotion regulation problems, and negative physical self-concept) play a 
substantial role in causing and sustaining somatic symptoms4,6. Therefore, psychological 
treatments such as cognitive behavioral therapy are the first line of treatment6. Still, individuals 
with somatic symptoms exhibit limited responsiveness to conventional psychotherapeutic 
approaches7. 
To remedy this, one possible approach is Dialectical Behavior Therapy (DBT), which aims 
to enhance dialectical thinking, a cognitive process that involves the ability to hold and reconcile 
opposing ideas or viewpoints and reflect on them curiously9,10. Few studies have shown that 
increases in dialectical thinking during psychological treatment have positive effects on attention, 
coping flexibility, and self-processing10 . 
A limited number of studies have examined the effects of DBT treatment among patients 
with somatic symptoms. One initial study exploring the effects of DBT in individuals suffering 
from somatic symptoms reported reduced somatization in patients diagnosed with borderline 
disorder, through an increase in emotional acceptance11.  

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Though promising, DBT is a long-term, in-person intervention that must be carried out by 
trained professionals and is, therefore, resource-intensive and inaccessible to many people. 
Therefore, we propose an alternative related intervention for individuals experiencing somatic 
symptoms, namely Pain-Acceptance Training. Similar to DBT, the Pain-Acceptance Training 
targets core mechanisms related to pain processing and modulation12,13. 
 
CURRENT INTERVENTION 
Pain-acceptance training is based on dialectical thinking, particularly in maintaining a 
dialectic perspective, on the suffering caused by the pain - simultaneously wishing it to end and 
accepting it. Acceptance-based pain interventions attempt to teach patients to experience their 
emotions, pains, and bodily sensations more fully and without avoidance, and to notice fully the 
presence of thoughts without following, resisting, believing, or disbelieving them12,13. Accepting 
thoughts and feelings impedes the control these exert over behavioral tendencies and limits their 
impact on pursuing personal goals14. Thus, even though acceptance-based strategies do not aim at 
pain reduction, various studies have shown that these strategies can alter the pain experience and 
therefore may be considered regulation strategies12,13. This training method is also easily 
implemented, and can be imparted to participants both online and in person. Research shows that 
short trainings in pain acceptance regulation strategies increase pain tolerance, enhance recovery 
from pain, lower pain anxiety, distress ratings, and negative emotions related to pain, and facilitate 
better overall functioning despite the pain12,13,15,16. 
 
Prior Clinical Experience 
In our recent randomized controlled single-session trial of pain-acceptance training that 
was conducted at the University of Haifa, healthy individuals showed reduced sensitivity to 
suprathreshold pain and reported an increase in pain threshold. This increase correlated with an 
increase in the vagal tone reactivity to pain, suggesting that the training modulates pain via the 
antinociceptive effect of the vagus nerve. Crucially and even more importantly, the reduction in 
pain sensitivity and increase in pain threshold were maintained for a month following the training, 
thus showing long long-lasting impact on pain perception. Furthermore, this training resulted in a 
decrease in pain catastrophizing levels one month later, suggesting that participants had better 
emotional capacities for dealing with pain17.  
 
 
 

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RESEARCH OBJECTIVES & SIGNIFICANCE 
As demonstrated, pain acceptance training showed promising results in altering the pain 
perception of healthy participants. The current study aims at translating these outcomes to a clinical 
setting; to examine a novel form of acceptance-training for pain relief in psychiatric patients 
suffering from somatic symptoms. We hypothesize that pain intensity, functional disability, and 
negative affect will decrease as a result of acceptance training, and that these changes will be 
mediated by an increase in patients’ dialectical thinking abilities.  
 
STUDY ENDPOINTS / OUTCOMES 
To the best of our knowledge, this is the first study to examine pain acceptance training in 
psychiatric patients with somatic symptoms. To determine the efficacy of the training, we will 
utilize different pain outcome measures, and assess emotional and cognitive correlates of the 
change. As such, we believe this study will provide preliminary data that will serve as a basis for 
further randomized control trials examining the clinical implications of acceptance based training 
compared to other standard pain-treatment methods, and exploring the mechanisms underlying 
pain acceptance training for somatic symptoms relief. 
Our primary training outcome measures will be pain-related, and will be conducted in three 
phases: Baseline, End of Intervention Assessments, and Follow-up Assessments. We expect that 
following two-week of acceptance training, patients will feel lower pain intensity and will show 
better abilities to cope with their pain. These improvements are expected to be maintained over 
time, and we will observe this in the follow up assessments.  
These measures include pain intensity assessment, assessment of the degree of widespread 
body pain, pain catastrophizing levels and pain self-efficacy believes, as well as actual pain coping 
measurement of cold pain threshold, and cold pain tolerance.  
The secondary training measures will include emotional state measures, dialectical 
thinking measures, and attention bias for pain. Demographic and medical records variables will 
serve as covariates for evaluating individual factors affecting training efficacy.  
 
 
 
 
 
 
 

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METHOD 
Overall Design & Objectives 
A prospective randomized two-arm controlled study assessing the effectiveness of-pain-
acceptance training in patients experiencing emotional distress and somatic symptoms. The study 
will consist of one hundred patients suffering from significant pain symptoms (based on their 
medical records and verified based on self-report assessments) recruited from the Psychiatric 
Outpatient Clinic, the Psychiatric Day Care department, and the Pain Relief Clinic. 
  
Study Population 
Participants in the current study will consist of 100 individuals experiencing significant 
pain symptoms and emotional distress (based on their medical records and verified based on self-
report assessments). Recruitment will take place at the Psychiatric Outpatient Clinic, the 
Psychiatric Day Care department, and the Pain Relief Clinic at Rambam Health Care Campus.  
 
Eligibility Criteria:  
A. Inclusion Criteria:  
a. Men and Women 
b. Aged 18-65 
c. Able to provide a signed informed consent 
d. Experiencing significant pain symptoms that interfere with daily-life functioning  
e. Experiencing significant emotional distress symptoms 
 
B. Exclusion Criteria: Patients under the age of 18 and/or diagnosed with one or more of 
the following diagnoses will be excluded from participation in the study: 
a. Patients rating their average pain in the last week and in the last month as less than 3 
in a 0-10 numerical rating scale (i.e. NPS) 
b. Patients rating their emotional distress levels as less than 25 in a 10-50 numerical 
rating scale (i.e. Kessler Psychological Distress Scale [K10]) 
c. Patients diagnosed with psychotic disorders and/or suffering from psychotic 
symptoms. 
d. Patients diagnosed with Autism Spectrum disorder. 
e. Patients diagnosed with Intellectual disability. 

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f. Patients diagnosed with eating disorders. 
g. Patients with Immediate suicidal risk. 
h. Patients who initiated a new drug and/or psychotherapy treatment within the last 
month. 
i. Pregnant women.  
j. Patients currently serving in the IDF.  
 
C. Early Discontinuation: 
a. Participant’s Withdrawal. Participants have the right to withdraw from the experiment at 
any time, for any reason, without facing any negative consequences. If a participant decides 
to discontinue their participation before the completion of the study, they are asked to 
inform the research team as soon as possible. The research team may conduct a follow-up 
assessment to gather information about the reasons for withdrawal and address any 
potential concerns or adverse events related to the intervention. When a participant 
withdraws from the experiment, they are compensated based on the parts they completed. 
b. Data collected before withdrawal. The confidentiality of the participant's personal 
information will be maintained, even in the case of early discontinuation. Data collected 
up to the point of withdrawal will be retained and included in the analysis, ensuring that 
the information collected until that time contributes meaningfully to the study outcomes. 
The reasons for participant withdrawal will be documented in the final study report to 
ensure transparency and to provide a comprehensive understanding of the trial's outcomes. 
 
D. Disqualification: 
Partial Participation and Non-Response. Participants who will not finish the first 
assessment meeting and/or will not understand the acceptance training strategy at the first 
session will be disqualified from the experiment. In instances when a participant fails to 
respond to the online home questions on more than two occasions, the experimenter will 
reach out to the participant to understand any challenges they may be facing and provide 
necessary support. However, if a participant will not respond to the survey on more than 
four occasions, and they do not make an effort to follow the requirements correctly, they 
may be excluded from further participation. Furthermore, participants who do not complete 
the assessment video-call in the middle of the experiment, will be disqualified from the 
experiment. Disqualification criteria will be applied thoughtfully, and any instances of 

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partial participation or non-response will be transparently documented in the final study 
report. Participants will be notified about the conditions for exclusion at the beginning of 
the experiment to ensure clear understanding, and they will be strongly encouraged to 
engage seriously with the requirements of the experiment. 
 
Study Procedure  
Potential candidates suffering from significant pain symptoms will be located by the 
clinical staff at the Psychiatric Outpatient Clinic, the Psychiatric Day Care department, and the 
Pain Relief Clinic and will be referred to the research staff for a comprehensive explanation of the 
study goals and procedure. Those who will agree, and sign the informed consent form, will be 
regarded as participants.  
Participants will then undergo a screening procedure that will include two stages: 
(1) Assessment of psychological distress levels (via the Kessler Psychological Distress 
Scale [K10]; Kessler et al., 2003). A cut-off score of ≥ 25 will be utilized, indicative 
of moderate-to-severe distress levels. Participants scoring < 25 will be considered 
“disqualified” and will not proceed to the second stage.    
(2) Assessment of clinical diagnosis using The Diagnostic Interview for Anxiety, Mood, 
and OCD and Related Neuropsychiatric Disorders (DIAMOND). This screening 
procedure will be delivered by an online meeting.  
Those who will meet the study’s criteria will undergo a battery of baseline assessments 
that will occur at either Rambam Hospital or the Cognition Emotion Interaction Lab at the 
University of Haifa – according to the participant’s choice. The baseline assessments will include: 
(i) Completion of a battery of questionnaires measuring pain severity, bodily dispersion of pain, 
somatization, pain catastrophizing, psychological symptoms, and dialectical thinking; (ii) 
Performing a short computerized cognitive task, measuring attention bias toward pain; (iii) Cold 
pressure task, to measure their cold pain threshold and cold pain tolerance. The CPT test is an 
internationally accepted test for pain assessment. The physical stimulation is in the range between 
pain threshold and personal endurance, so that the participant controls the duration of the 
stimulation and can stop it at any moment according to his will and there is no risk of harm. 
Following the assessment, participants will be randomly assigned to one of the study 
groups: pain-acceptance intervention group (n=50) or treatment-as-usual group (n=50). The 
procedure of the pain-acceptance group is detailed bellow, in the ‘Intervention Procedure’ section.  
At the end of the treatment phase (i.e., 2 weeks), participants in both groups will undergo a second 
session of assessments, in the same location as the first assessment meeting (i.e. either in Rambam 

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Hospital or in the Cognition Emotion Interaction lab at the University of Haifa). This session will 
include: (i) Completion of a battery of questionnaires measuring pain severity, bodily dispersion 
of pain, somatization, pain catastrophizing, psychological symptoms, and dialectical thinking; (ii) 
Performing a short computerized cognitive task, measuring attention bias toward pain; (iii) Cold 
pressure task, to measure their cold pain threshold and cold pain tolerance. At the end of this 
assessment session, participants from the ‘treatment as usual’ group will then be offered to receive 
the pain-acceptance treatment. 
After 2 weeks from the end of intervention assessment session, participants will undergo a "follow-
up" phase. As part of this phase, participants will be asked to complete a battery of questionnaires 
measuring pain severity, bodily dispersion of pain, somatization, pain catastrophizing, 
psychological symptoms, and dialectical thinking. These questionnaires will be delivered online, 
and participants will receive a secure link via email to access and complete them remotely.  
All the assessments, including the cognitive and the cold pressure tasks, will be conducted 
by a trained research assistant, Ph.D. or M.A. level student, from the Cognition Emotion 
Interaction (CEI) Lab, Psychology Department, and the Sensory Neuroscience and Pain 
Laboratory, Physical Therapy Department, at the University of Haifa. Furthermore, clinical data, 
such as diagnosis, time from first diagnosis, medications, targeted interventions for pain 
management, and participation in psychological treatment, will be retrieved from the medical 
records. All data will be collected and stored in a coded manner. No personal information will be 
used. For further details, please refer to the “Ethical Issues” section.  
For participating in the study, participants will be remunerated with monetary 
compensation as follows: 100 NIS for participation in the first assessment session; 100 NIS for the 
daily online questionnaire (except for drop-out participants due to low adherence to the daily 
assessments); 20NIS for the online 15-minute video call in the middle of the training week; and 
130 NIS for completing the end of intervention assessment session; 50 NIS for completing the 
follow-up phase. Taken together, for completing all parts of the experiment, participants will be 
remunerated with monetary compensation of 400 NIS, which will be funded by Prof. Irit 
Weissman-Fogel from Haifa University.  
 
Intervention Procedure 
Participants in the pain-acceptance group will undergo a two-week training in the pain-
acceptance strategy. At the end of the first session, participants will receive a 40-minute 
explanation about the pain-acceptance emotion regulation strategy and will practice it with the 
experimenter.  

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The practice will start with a short conversation and inquiry about the participant’s pain 
while continuously validating his experience and creating a shared understanding of their struggles 
and difficulties due to the pain. Next, the experimenter will explain the relations between distress, 
pain and suffering, emphasizing that in many cases trying to control our pain, emotions and 
thoughts leads us to undesirable results through emotional avoidance, anger and escape. This 
explanation will be accompanied with commonly used metaphors to enhance participants' 
understanding. Afterwards, participants will be familiarized with the strategy of "emotional 
acceptance of pain". The strategy will be comprehensively explained and participants will practice 
it with the experimenter twice: Firstly, by practicing with the mental exercise of “STOP” (i.e. 
acronyms representing Stop, Take a step back, Observe, Procced Mindfully); Secondly 
participants will be asked to immersing their dominant hand again into a bucket containing cold 
water, and will practice, together with the guidance of experimenter, the pain acceptance strategy 
while feeling moderate pain. After each practice, participants will discuss their experience with 
the experimenter.  
Finally, in the last part of the intervention, they will be introduced to the two weeks at-
home training. Participants will be asked to think of the pain acceptance training and use it for a 
few minutes every time they feel pain. Every time they use the pain strategy, they are asked to 
report it by clicking on the "Now" button found in the link that will be accessible to them through 
their mobile phones. 
During the two-week at-home training period (including Fridays and Saturdays, unless they 
observe Shabbat and request an exemption), a brief online survey will be send to the participants 
daily in the evening via text massage. The survey will include questions about pain severity, 
functional disability in the past day, the frequency of using pain acceptance training in the past 
day, and its perceived ease. If difficulties arise in the use of the therapeutic strategy, the 
experimenter will contact the patient via a phone call, and will explain how the training should be 
carried out with the learned acceptance strategy once more. Additionally, at the end of the first 
week of the training, the experimenter will conduct a short 15-minute video call with the patient, 
to discuss the progress and the difficulties that arise in using the acceptance training.  
At the end of the at-home training, participants will be asked to arrive at Rambam Hospital 
for the second session of the assessments (i.e., the Follow-Up assessment), which will include 
completing the same questionnaire battery, perform the short computerized cognitive task, and 
undergo the cold pressure task as in the first session.  

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Two weeks after the end of intervention assessment session, participants will be asked to complete 
the same battery of questionnaires as administered in the previous assessment session. This follow-
up assessment will be conducted online. 
 
Treatment as usual group 
Participants in the ‘treatment as usual’ group will be also complete the daily online 
evaluations during two weeks. During this period (including Fridays and Saturdays, unless 
participants observe Shabbat and request an exemption), starting on the day after the initial 
assessment, a brief online survey will be sent to the participants daily in the evening via text 
massage. The survey will include questions about pain severity and functional disability in the 
previous day.  
Additionally, at the end of the first week of the experiment, the experimenter will conduct 
a brief 15-minute video call with the participant. During this call, they will discuss the previous 
week and the participant's progress with the daily assessments. At the end of the at-home two-
week pain evaluation, participants will be asked to arrive at Rambam Hospital for the end of 
intervention session of the assessments (i.e., the Follow-Up assessment). At the end of this 
assessment session, participants from this group will then be offered to receive the pain-acceptance 
treatment. 
Two weeks after the end of intervention assessment session, participants will receive a link 
to complete online the same battery of questionnaires as administered in the previous session.  
 
Detailed overall procedure 
The overall procedure will include the following stages: 
A. Screening 
Participants will undergo an initial assessment of the study’s criteria, including pain levels, 
pregnancy, initiation of a pharmacological and/or psychotherapy treatment, and psychological 
distress levels. Participants scoring ≥ 25 on the K10 psychological distress scale will be considered 
as likely to have moderate-severe distress levels, and will proceed to the subsequent screening 
stage. Next, participants will undergo clinical diagnosis using the Diagnostic Interview for 
Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) (i.e. a new semi-
structured interview that targets the diagnostic criteria for a range of DSM-5 disorders, with 
additional clinical information) that will be performed by a clinician or a trained mental health 
professional from the research team. Those who will meet the study criteria (detailed in the 

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‘Inclusion’ & ‘Exclusion’ sections), will be regarded as ‘Participant’ and will be asked to complete 
the baseline evaluation. 
   
 
B. Baseline Assessments 
All participants who meet the study criteria will complete a battery of questionnaires 
measuring pain severity, bodily dispersion of pain, somatization, pain catastrophizing, 
psychological symptoms, and dialectical thinking. Then, they will be asked to perform a short 
computerized cognitive task, measuring attention bias toward pain. Afterward, participants will 
complete the cold pressure task, to measure their cold pain threshold and cold pain tolerance. 
 
C. Weekly Assessments 
Participants allocated to the pain-acceptance group will be asked to complete a few 
questions assessing pain severity and functional disability, as well as their training experience and 
verify compliance with the training. The online questions will be sent to participants' phones daily 
(including Fridays and Saturdays, unless participants observe Shabbat and request an exemption) 
at the evening during the training weeks by a text message (see Appendix 11). In case participants 
report challenges in implementing the intervention routinely, the research staff will contact the 
patient via a phone call, and will explain once again how the training should be carried out with 
the learned acceptance strategy. Furthermore, in the middle of the training period, the participant 
will meet with the experimenter for a 15-minutes video-call meeting, in which the experimenter 
will explain the acceptance training again, verify compliance with the training and answer further 
questions aroused during the training period.  
 
D. End of Intervention Assessments 
At the end of the two-week at-home training, all participants (i.e. both from the treatment 
as usual and the active groups) will be asked to arrive at Rambam Hospital for the  end of 
intervention assessment. The assessment will include performing the short computerized cognitive 
task measuring attention bias toward pain, followed by a second battery of questionnaires 
measuring pain severity, bodily dispersion of pain, somatization, pain catastrophizing, 
psychological symptoms, dialectical thinking, and a brief questionnaire regarding their 
experiences in the experiment. Last, participants will complete the cold pressure task, to measure 
their cold pain threshold and cold pain tolerance. 
 
E. Follow-Up Assessments 

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Two weeks after the end of interventionassessment session, participants from both of the groups 
will undergo an online follow up assessment. The assessment will include battery of 
questionnaires measuring pain severity, bodily dispersion of pain, somatization, pain 
catastrophizing, psychological symptoms, dialectical thinking, and a brief questionnaire 
regarding their experiences in the experiment (the same questionnaires as in the End Of 
Intervention Assessment). The questionnaires will be delivered online, and participants will 
receive a secure link via email to access and complete them remotely. 
 
 
Experiment Timeline 
 
 
 
Measures: 
1. Demographic 
The demographic questionnaire was constructed for the present study and covers inquiries 
about the date of birth, gender, religion, level of religiosity, marital status, number of children, 
economic status, years of education, medications, current treatments, and chronic disease diagnoses. 
 
2. Clinical Evaluations 
a) Kessler Psychological Distress Scale [K10] is a 10-item questionnaire intended to yield a 
global measure of distress based on questions about anxiety and depressive symptoms that 
a person has experienced in the most recent 4-week period. Scores range from 10 to 50 as 
follows: 1) scores under 20 are likely to be well; 2) scores 20-24 are likely to have a mild 
disorder; 3) scores 25-29 are likely to have moderate disorder; and 4) score 30 and over are 
likely to have a severe disorder. 

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b) The Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric 
Disorders (DIAMOND). The DIAMOND (Tolin et al., 2016) is a new semi-structured 
interview that targets the diagnostic criteria for a range of DSM-5 disorders, with additional 
clinical information gathered for anxiety, mood, and obsessive-compulsive and related 
disorders. The administration time of the DIAMOND is approximately 1 hour, making it 
feasible for use in research, clinical, and training settings. DIAMOND diagnoses show very 
good to excellent interrater reliability, and good to excellent test–retest reliability using 
cutoff criteria from the DSM-5 field trials (Clarke et al., 2013; Kraemer et al., 2012). Test–
retest reliability of DIAMOND diagnoses ranges from good to excellent, and convergent 
validity was established (Tolin et al., 2018).  
 
3. Self-Reported Questionnaires 
a) Michigan Body Map. A self-report measure assesses body areas where chronic pain is 
experienced and specifically quantifies the degree of widespread body pain when assessing 
for centralized pain features20. See Appendix 1. 
b) Pain catastrophizing scale (PCS). The PCS contains 13 items that measure catastrophic 
thoughts about pain in both clinical and non-clinical samples. Participants reflect on past 
painful experiences and indicate on a 5-point scale ranging from zero (“not at all”) to four 
(“always”) the degree to which they experience each of the 13 thoughts or feelings during 
the experience of a pain (i.e. “When I'm in pain it's terrible and I think it's never going to 
get any better”). Research has shown that the PCS is valid and reliable21. See Appendix 2. 
c) Brief pain inventory - short form (BPI-SF). The BPI-SF is a well-validated, widely used, 
and frequently recommended instrument that measures pain severity and pain-related 
interference for patients with chronic pain conditions. BPI-SF evaluates pain severity at its 
worst, least, and average during the previous week, as well as current pain level, with 0 
representing no pain and 10 the worst pain imaginable. Seven items measuring interference 
with daily functioning (general activity, walking, work, mood, relations with others, sleep, 
and enjoyment of life) are also assessed on an 11-point scale, where 0 represents no 
interference and 10 complete interference. The scores can be averaged to the two 
components of the BPI-SF score, the Pain Severity Index and the Pain Interference Index. 
Both BPI scales show responsivity in detecting and reflecting improvement in pain over 
time. See Appendix 3. 
d) Pain self-efficacy questionnaire (PSEQ). The PSEQ assesses the strength of a person’s 
confidence in their ability to function, despite their pain. Patients are asked to rate how 

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confident they are so that they can do each of the 10 activities or functions at present, 
despite their pain, by selecting a number on a seven-point scale, where zero equals ‘not at 
all confident’ and six equals ‘completely confident’. Scores on the PSEQ may range from 
0 to 60, with higher scores indicating stronger self-efficacy beliefs. Good reliability and 
validity of the PSEQ has been reported. The test–retest reliability and internal consistency 
of the PSEQ in two different studies with chronic pain patients were reported as 0.79 and 
0.92, respectively. See Appendix 4. 
e) The Generalized Anxiety Disorder 7-Item Scale (GAD-7). A self-report questionnaire 
with 7 items describing anxiety symptoms. In this questionnaire, the participant is asked to 
describe how well each statement describes his situation in the past two weeks, on a 4-
point Likert scale (0 - not at all, 3 - almost every day). The questionnaire is acceptable for 
use for research and clinical purposes to detect anxiety symptoms in general, and general 
anxiety symptoms in particular, both in the general population and in clinical populations. 
The questionnaire has good psychometric properties including high internal reliability 
(Cronbach's alpha index = 0.89), and high validity indices. See Appendix 5.  
f) Patient Health Questionnaire-9 (PHQ-9). A self-report questionnaire for adults, the 
purpose of which is to examine the presence and severity of clinical depression23. The 
questionnaire includes 9 items that are a list of major depressive symptoms, according to 
the DSM. For each item, the examinee is asked to estimate how often he was bothered by 
the statement described in the item during the last two weeks, on a 4-point Likert scale of 
3 (0 - not at all, 3 - almost every day). In addition, the examinee was asked how much the 
problems he reported made it difficult for him to do his job, take care of things at home or 
get along with others. This last item is important and significant to assess the degree of 
distress caused to a person by his symptoms, and the score in it is closely related to the 
degree of the person's quality of life. This questionnaire is frequently used, and has good 
psychometric data (reliability, internal consistency, Cronbach's alpha ranges from 0.86 to 
0.89), and the construct and convergent validity indices are reported to be high. See 
Appendix 6. 
g) Acceptance and Action Questionnaire (AAQ-II). The measure most commonly used to 
assess psychological inflexibility, particularly in the context of Acceptance and 
commitment therapy research, is the Acceptance and Action Questionnaire – II (AAQ-II)25. 
The AAQ-II has been used across nonclinical and clinical samples. The AAQ-II 
demonstrated factor structure stability, internal consistency, test-retest reliability and 
discriminant validity. The AAQ-II appears to measure a unidimensional factor across 

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varied samples, consistent with theory that suggests psychological inflexibility functions 
as a coherent construct. In addition, as predicted, the AAQ-II was associated with higher 
levels of depression, anxiety, stress, and overall psychological distress. See Appendix 7. 
h) The Dichotomous Thinking Inventory (DTI). The Dichotomous Thinking Inventory 
(DTI) is a self-report measure used to assess a black-and-white cognitive thinking style or 
worldview26. The questionnaire assesses an individual’s dichotomous thinking style in a 
general setting by measuring the degree of positive view of dichotomy, such as 
dichotomous thinking being better than other thinking styles and dichotomy being 
consequent, deserved, and worthy. The DTI has 15 items scored on a 6-point scale ranging 
from 1 = disagree strongly to 6 = agree strongly. The DTI has 3 components: preference 
for dichotomy, dichotomous beliefs, and profit-and-loss thinking. See Appendix 8. 
i) The Dialectical Self Scale (DSS). The Dialectical Self-Esteem Scale (DSS) is a validated 
and reliable measure that assesses dialectical self-esteem as related to self-perception27. 
The DSS is a 32-item instrument using a 7-point Likert scale ranging from strongly 
disagree to strongly agree to measure the perception of dialecticism. Sixteen items describe 
scenarios that are inconsistent with naive dialecticism which are reverse-scored to 
determine a dialectical self-esteem rating, with high scores representing greater degrees of 
dialecticism (i.e. individuals who are "more dialectically oriented"). See Appendix 9. 
j) Patient’s global impression of change (PGIC) scale. Patients rate their improvement on 
a seven-point scale, where 0 equals “very much worse” and 6 equals “very much 
improved”. This scale will be asked only in the last session, at the end of the intervention 
period. Patients themselves make a subjective judgment about the meaning of the change 
to them following treatment, this scale is often taken as the external criterion or “gold 
standard” of clinically important change. However, this method, by itself, does not indicate 
what has improved. See Appendix 10. 
 
4. Tasks / Tests  
a) Perception Load (PL). Patients will perform a computerized version of the emotional 
modification of the perceptual load paradigm17,18,19. In this task, participants are required to 
indicate whether a target letter (X or N) appears on the screen, by responding to the corresponding 
letter on the keyboard. The task contains two perceptual load conditions, low and high, which are 
determined by the number of distracting letters appearing alongside the target letter. In the low 
load condition, one distracting letter appears on the screen alongside the target letter, whereas in 
the high load condition, four distracting letters appear on the screen together with the target letter 

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(see figure 2). The distracting letters are chosen randomly from the letters K, H, V, Z, or W. The 
target and distracting letters will appear randomly in six possible locations that create an imaginary 
circle at the center of the screen. The distracting pictures can be either neutral or pain-related one. 
 
Figure 2. Examples of typical trials of the perceptual load task. A) Low load condition of the task. In the low load 
condition, one letter appears on the screen, and the participant needs to indicate whether it is one of two letters (either 
X or N). In this example, the distracting picture is neutral. B) High load condition of the task. In the high load 
condition, five letters appear on the screen, and the participant needs to indicate whether one target letter (either X or 
N) appears on the screen. In this example, the distracting picture is pain-related.  
 
b) Cold Pressor Task (CPT). Pain will be induced with the cold pressor task (CPT). The cold 
pressor task consists tub containing cold water. Water’s temperature will be kept at 10-12°C, to 
create a moderate pain sensation. This is a usual temperature range when studying pain, and based 
on our vast experience with this task it appropriate for the present experiment. The tub will be 
filled with water, and two ice bottles will be inserted in the sides of the tank to cool the water to 
the desired temperature. Water temperature will be assessed by a thermometer before the 
beginning of the session, as well as just before hand immersion to verify the stability of the 
temperature.  
It is important to note that the CPT test is an internationally accepted test for pain 
assessment, and is a measure commonly used in Prof. Weissman-Fogel experiments. This task in 
delivered by trained experimenters and the physical stimulation is in the range between pain 
threshold and personal endurance, so that the participant controls the duration of the stimulation 
and can stop it at any moment according to his will, thus there is no risk of harm.  

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Participants will be seated in a chair adjacent to the container and asked to immerse their 
non-dominant hand into the tab for as long as they feel able to do so. Maximum duration of 
immersion will be five minutes. Based on our previous experience with the task, the mean 
immersion duration is expected to be ~20-30 seconds. The two primary outcome measures will be 
taken during the cold pressor task. The first will be pain threshold, which indicates the number of 
seconds from immersion in the tub that the participant first reported feeling pain. Threshold is a 
behavioral index of hypervigilance towards the pain experienced in the cold pressure. As such, 
conceptually it is the most likely to be affected by acceptance training. The second outcome 
measure will be pain tolerance, which indicates the number of seconds from immersion in the tank 
that the participant can tolerate the pain. As in the acceptance training participants learn and 
practice to accept without judging or reacting to their pain sensations and to recognize that its 
presence is only temporary and will soon pass, we hypothesize that the patients in the active 
training will be able to tolerate the cold pain for longer durations of time.  
 
5. Clinical data 
The following clinical data will be retrieved from the medical records: Listed diagnosis, time 
from first diagnosis, medications, targeted interventions for pain management, and participation 
in psychological treatment. 
 
Safety Measures  
Participants will be encouraged to report any unexpected events or concerns to the research 
team as soon as possible. The team will conduct a thorough assessment, providing appropriate 
support, and, if necessary, adjusting the intervention or involving additional healthcare 
professionals. The safety and well-being of participants remain our utmost priority, and every 
effort will be made to respond to unexpected events in a timely, ethical, and responsible manner.  
 
Analyses 
A. Calculating Sample Size:  
The sample size for the current research was calculated based on our previous study 
examining the efficacy of acceptance training for altering pain in healthy individuals. In this study, 
we examined the immediate and long-term effects of a single session of acceptance training on 
pain perception. In a sample of 40 healthy females who completed the training, we found some 

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immediate pain reduction gains, and that these effects were maintained for one month after, and 
even increased with time. Hence, we elected to employ similar sample size for the current 
experiment, comprising 50 participants in both the acceptance intervention and treatment as usual 
groups, as it appears appropriate for discerning the anticipated pain reduction effects. 
Nevertheless, we chose to extend the training duration in the current experiment to amplify the 
assimilation and utilization of the acceptance coping strategy.  
 
B. Change in Outcome measures:  
Planned analysis: 
Primary and secondary outcome analysis. To evaluate training efficacy, we will 
examine whether the training affected the primary outcome measures of pain sensitivity. 
Therefore, we will compare the pre-post difference on each measure between the active training 
group and treatment as usual by using repeated measures ANOVA analysis. Then, to evaluate the 
behavioral, affective and cognitive effects of the acceptance training, we will use the same analysis 
method to examine whether the training affected the secondary training outcomes (i.e., emotional 
state measures, attention bias toward pain-related information, and dialectical thinking). 
Mediation analysis. Next, we will examine whether the changes in pain and mood 
following the acceptance are mediated by an increase in patients’ dialectical thinking abilities. For 
this aim, we will conduct a multilevel mediation analysis in R. 
Regression analysis. To examine which individual differences contribute to the 
acceptance training efficacy, we will conduct stepwise regression analyses between the primary 
pain outcomes and the demographic and trait self-report variables. In addition, for 
comprehensiveness, we will explore the correlation matrix between all the measures taken in this 
study. Furthermore, additional exploratory analyses will be conducted between the individual 
variables and the secondary training outcomes. 
Trajectories of change in pain following the acceptance training. In a further analysis, 
we will analyze the patterns of change following the use of the acceptance coping strategy. For 
this aim, we will analyze the daily data gathered from participants during the training phase, to 
examine whether changes in acceptance abilities predict subsequent changes in pain intensity, pain 
disability, and mood. These analyses will be conducted by using linear mixed model analyses.  
All data analyses for this study will use IBM SPSS Statistics, version 25 (IBM Corp., 
Armonk, NY, United States) and R Statistical Software (v4.1.2; R Core Team 2021). 
 
 

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PESONNEL TRAINING  
 
The research team will undergo comprehensive training to ensure precise and consistent 
administration of the DIAMOND interview, tasks, and questionnaires at the initiation of the 
experiment. Additionally, the team will engage in practice sessions to proficiently convey 
explanations related to the pain-acceptance training, with a focus on clarifying and refining 
instructions during training. Furthermore, the research team will be equipped with training to 
adeptly address patients' needs and handle any challenges that may arise throughout the study. 
 
ETHICAL ISSUES 
Participants will be allowed to withdraw or discontinue their participation in the study at 
any time. Early discontinuation will not affect the participant's existing medical care or relationship 
with their healthcare provider. 
To guarantee the anonymity and confidentiality of all participants across both study groups, 
each of them will be coded in the following way: 
1. The pain-acceptance intervention group will be identified by the code “P”, followed by 
sequential numbers representing the number of participants (i.e., P1-P50) 
2. The ‘treatment as usual’ group will be identified by the code “C”, followed by sequential 
numbers representing the number of participants (i.e., C1-C50) 
All participant data will be exclusively recorded and stored in the database using this 
coding system. First names, IDs, and other personal identifiers that will be obtained in this study 
will be kept confidential and separate from the identifying details of the patients. Only the PI and 
Sub-PIs will have access to this information.  
All questionnaire data will be collected through Qualtrics, a secure platform with a 
username and password. The questionnaire will be sent to the patient's phone number and will 
have a unique link that identifies him with his subject number. 
Participation payment will follow the rules of the Rambam Hospital for paying research 
participation.  
The cold stimuli employed for assessing patients' pain threshold and tolerance in the 
current experiment (i.e., the CPT task) are controlled and widely utilized in laboratories globally, 
including Prof. Irit Weissman-Fogel's laboratory. These stimuli fall within the range of pain 
threshold to moderate intensity, ensuring they pose no risk of harm. Participants retain the 
autonomy to cease the cold stimulation at any point during the experiment. 
If abnormal findings indicative of any psychiatric state or suicidal risk emerge during the 
Diagnostic Interview for Anxiety, Mood, OCD and Related Neuropsychiatric Disorders 

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(DIAMOND), participants will be immediately referred to the PI, a qualified psychiatrist, for 
further examination. 
Finally, during the two weeks of the training, patients will be able to contact the PI in case 
of exacerbation of pain. Moreover, during the training period, patients are asked to complete 5-
times weekly questions. Thus, in case participants report difficulties or exacerbation of pain, they 
will be contacted by the research team.   
 

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