Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Phase: NA
Conditions: Depression
Sponsor: New York State Psychiatric Institute

Signed copy on file at IRB 
 
             v. 02/26/19 
New York State Psychiatric Institute 
Institutional Review Board 
 
September 3, 2021 
 
To: 
 
Dr. Ronit Kishon 
From:  
Dr. Edward Nunes, Co-Chair 
 
 
Dr. Agnes Whitaker, Co-Chair 
 
 
 
 
Subject: 
Approval Notice*: Continuation 
 
Your protocol # 6806R entitled: PSYCHOLOGICAL MINDEDNESS AS A PREDICTOR OF COGNITIVE 
BEHAVIOR THERAPY OUTCOME (FORMERLY #5768) Protocol version date 09/03/2021 and consent 
forms have been approved by the New York State Psychiatric Institute - Columbia University 
Department of Psychiatry Institutional Review Board from September 9, 2021 to September 8, 
2022. (Reviewed at the Full Board meeting on August 23, 2021.) 
 
Consent requirements: 
      Not applicable:  
    45CFR46.116 (f)(3) waiver of consent  
     √  Signature by the person(s) obtaining consent is required to document the consent process 
      Documentation of an independent assessment of the participant’s capacity to consent is also 
required. 
Approved for recruitment of subjects who lack capacity to consent: √ No  Yes    
 
 
Field Monitoring Requirements: √ Routine  Special: ___________________  
 
 
  Only copies of consent documents that are currently approved by the IRB may be used to obtain 
consent for participation in this study. 
  A progress report and application for continuing review is required 2 months prior to the 
expiration date of IRB approval. 
  Changes to this research may not be initiated without the review and approval of the IRB except 
when necessary to eliminate immediate hazards to participants.  
  All serious and/or unanticipated problems or events involving risks to subjects or others must be 
reported immediately to the IRB.  Please refer to the PI-IRB website at http://irb.nyspi.org for 
Adverse Event Reporting Procedures and additional reporting requirements.    
 
*Approved under 45CFR46.204 
 
Cc: 
RFMH Business Office (NIMH 1R21 MH121915-01A1) 
 
Encl:  CF, recruitment materials, HIPAA 
 
 
EN/AHW/alw 

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Kishon, Ronit
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Protocol Title:
Psychological Mindedness as a Predictor of 
Cognitive Behavior Therapy Outcome 
(formerly #5768)
Protocol Number:
6806R
First Approval:
09/10/2013
Expiration Date:
09/08/2022
Version Date:
09/03/2021
Contact Principal Investigator:
Ronit Kishon, PHD
Email: kishonr@nyspi.columbia.edu
Telephone: 646 774 8030
Co-Investigator(s):
Jurgen Kayser, PHD
Maren Westphal, PHD
Research Chief:
B. Timothy Walsh, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Clinical Therapeutics
Within the department, what Center or group are you affiliated with, if any? 
Depression Evaluation Services
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.

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Page 2 of 21
None 
Application for Continuation of Research
Status
Current Status of Study: 
Subject enrollment is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
The first 3 months, we were challenged by COVID, and recruitment was sparse; however, after 6 months, 
we were actively recruiting patients as expected. Patients come to PI only for blood work and EEG tests at 
baseline and the end of the study.  Therefore, they come to PI only 3 times during the study and are not at 
risk besides the usual risk of being currently going outside due to COVID.  In addition, they receive 12 CBT 
sessions on Zoom, and they fill the self-report measure on RedCap. These procedures are running well and 
seem to be as effective as they were when done in person. We are looking forward to continuing another 
year of the R21.
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 

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No
Overall Progress
Approved sample size
150
Total number of participants enrolled to date
124
Number of participants who have completed the study to date 
116
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
18-70
Total number of participants enrolled from this population to date 
126
Gender, Racial and Ethnic Breakdown 
Adults
White 
(not 
Hispanic 
origin)
Black
(not 
Hispanic 
origin)
Hispanic
Asian or 
Pacific 
Islander
American 
Indian/Alaskan
Native
other
Total
Female
53
4
5
6
0
2
72
Male 
37
6
5
6
0
0
54
Total 
92
10
10
12
0
2
126
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
16
Number of participants currently enrolled
10
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No

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Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Psychiatric Assessment
   Neuropsychological Evaluation
   Psychotherapy Trial
   Audio or Videotaping
   Internet-based Data Collection or Transmission
Population
Indicate which of the following populations will be included in this research
   Pregnant Woman
   Adults
   Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
Yes
Select one of the following
The grant/contract is currently funded
Source of Funding
Federal
Institute/Agency
NIMH
Grant Name
R21
Grant Number
1R21MH121915 - 01A1
Select one of the following
Single Site
Business Office

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RFMH
Does the grant/contract involve a subcontract? 
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
      Psychological Mindedness (PM) is viewed as the ability and motivation to achieve a psychological 
understanding of the self. A person is considered to be psychologically minded if she or he can access their 
feelings, is willing to try and understand oneself and others, and has an interest in the meaning and 
motivation of his or her own and others’ behavior.  Historically, interest in PM grew out of attempts to 
identify patients best suited for psychoanalytically oriented psychotherapy. There has been limited attention 
regarding its potential impact on other therapeutic approaches. In recent years different theorists (Conte, 
Ratto, and Karusa, 1996; Grant, 2001) have noted that PM may have particular relevance for cognitive 
behavioral therapy (CBT) because PM includes self-monitoring and self-evaluation of one’s cognitions, 
emotions, and behaviors which are central to the successful practice of CBT. This study aims to see if PM is 
a component in the mechanism of change that is activated in CBT treatment for depression. As such, it may 
be related to change of symptoms during CBT, and at post-treatment. Mindfulness is another construct of 
self-awareness that is related to PM and yet distinct. We are studying to see its role in CBT for depression, 
and its relationship with PM. We will be administrating a few self-report measures of PM that have been 
used in other studies. We will also begin validating a structured interview of PM that we created in our 
lab. We also measure other concepts found to be related to PM and mindfulness, rumination, alexithymia, 
and self-compassion. 
Our studies and those of other researchers have found evidence that pretreatment resting EEG, event-related 
brain potentials (ERPs), and performance on neurocognitive tests show promise of being predictors of 
subsequent clinical response to antidepressants or CBT.  However, the extent to which these tests predict 
response to specific treatments for depression or the mechanisms underlying successful response to CBT is 
not known. We propose to test depressed patients before they begin a treatment study as well as after 
treatment (pre-post design) to confirm the value of resting EEG, ERPs, dichotic listening, and 
neuropsychological tests for predicting treatment response in MDD. Patients will be randomized between 12 
sessions of CBT and a control condition of non-specific supportive therapy for 12 weeks so to match the 
experimental condition of CBT with respect to receiving support by a professional, creating an alliance with 
the therapist, length of sessions, and duration of treatment.
 

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Background, Significance and Rationale
Background, Significance and Rationale
Depression is one of the most common psychiatric conditions in the United States. It is a chronic and 
disabling disorder associated with substantial impairment, decreased quality of life, and psychiatric 
comorbidity. The two standard treatments for depression are pharmacotherapy and cognitive behavior 
therapy (CBT). Both treatment modalities are similar in that they are only moderately effective, with a large 
proportion of patients remaining symptomatic after the initial intervention. Possibly the primary reason for 
the substantial individual differences in treatment responsiveness is heterogeneity within current psychiatric 
disease categories, which are present at all levels (i.e.genetic, neurobiological, and psychological levels) 
(Hollon et al., 2006). In the present study, we measure the changes in self-awareness and specific 
biomarkers through 12 weeks of CBT for depression and a control condition of 12 weeks of 
psychoeducation for depression. Psychological mindedness (PM), an aspect of self-awareness, has long 
been considered to be an essential psychological mediator for therapy outcome. Through the history of 
clinical psychology, PM was mostly used intuitively by clinicians to evaluate the psychotherapy process, 
and more specifically, in predicting a patient’s ability and motivation in psychotherapy (Farber & Golden, 
1977). However, most definitions and measures of PM have approached the task from a psychodynamic 
perspective, thus limiting the use of this construct by clinicians and researchers from evidence-based 
psychological perspectives, such as CBT (Grant 2001). Two measures presently being used in studies, the 
Psychological Mindedness Scale (PMS) (Conte, Ratto, & Karasu 1996), and the more recent measure, 
Balanced Index of Psychological Mindedness (BIPM) (Nyklíček & Denollet, 2009), have shown some 
predictive value in different studies of treatment in mentally ill patients. They have not though been 
thoroughly investigated as predictors in evidence-based psychotherapies such as CBT for depression. A 
third measure, the Self-Reflection Index Scale (SRIS; Grant, Franklin, & Langfirm) is an evolved form of 
the Private Self- Consciousness Scale (PrSCS; Fenigstein, Scheier, & Buss, 1975) which is another method 
to assess PM, and also recommended in RDoC as a measure of self- knowledge. SRIS is compromised of 
two separate factors labeled Self-Reflection (SRIS-SR) and Insight (SRIS-IN) which are parts of self- 
awareness but differently correlate with depression: in studies, the SRIS-SR correlated positively with 
anxiety and stress, but not with depression and alexithymia. The SRISIN was negatively correlated with 
depression, anxiety, stress, and alexithymia, and positively correlated with cognitive flexibility and self-

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regulation (Grant at el. 2002). In addition to PM we examine other concepts that relate to self-awareness so 
to capture the whole spectrum of one's ability and will to observe oneself. Mindfulness has been found to 
relate to the construct of PM in a nonclinical sample (Beitel, Ferrer, & Cecero, 2005), yet no study has 
examined its relationship with PM in a clinical sample despite a growing body of research supporting the 
role of mindfulness in facilitating clinical improvement in CBT. We measure facets of mindfulness that are 
particularly relevant to PM and examine their interactions and relative contribution to predicting CBT 
outcomes in depressed patients. We added a rumination measure because it is a core process in the 
development and maintenance of depression. Consistent with research indicating a distinction between 
rumination as a maladaptive form of self-attentiveness, and reflection as an adaptive intellectual form of 
self-attentiveness thought to underlie PM (Trapnell & Campbell, 1999), we examine the added value of the 
level of rumination in predicting CBT outcome and its longitudinal relationship with PM through the CBT. 
Another important construct that has been lately related to different forms of self-awareness and self-
observation is self-compassion (Neff, 2003). This is a third construct that may be important for 
understanding the proposed relationship between increases in PM and symptomatic improvement in 
depression throughout treatment. There is increasing evidence that self-compassion is a robust predictor of 
lower psychopathology (for reviews, see Barnard & Curry, 2011; MacBeth & Gumley, 2012). A recent 
controlled treatment study suggests that self-compassion is a particularly salutary form of emotion 
regulation in individuals with high levels of depressed mood (Diedrich, Grant, Hofmann, Hiller, &Berking, 
2014). To our knowledge, no published research has yet examined the relation between PM and self- 
compassion. Individuals high in PM may be more likely to develop greater self-compassion throughout 
CBT treatment as PM taps qualities that may be essential to developing self-compassion. We examine 
potential interaction effects for self-compassion and PM in the prediction of depression levels pre and post 
CBT treatment, for example, PM-related symptomatic improvement in depression may be more pronounced 
for individuals scoring high in self-compassion. Studies have found evidence that pre-treatment resting 
EEG, event-related brain potentials (ERPs), and performance on neurocognitive tests show promise of being 
predictors of subsequent clinical response to antidepressants or CBT (Bruder, Kayser, & Tenke, 2012). 
However, the extent to which these tests predict response to specific treatments for depression or the 
mechanisms underlying successful response to CBT are not known. We propose to test depressed patients, 
under Dr. Kayser's protocol (#6559) before they begin a treatment study, both in the CBT condition and 
control condition, as well as after treatment (pre-post design) to confirm the value of resting EEG, ERPs, 
dichotic listening, and neuropsychological tests for predicting treatment response in MDD. Patients are 
retested after the successful completion of CBT, which will take 12 weeks and at the end of 
psychoeducation treatment (12 weeks). The development of biomarkers for predicting treatment response 
would be important for personalizing treatment in depression (i.e., determining who will and who will not 
respond to CBT).
Specific Aims and Hypotheses
Specific Aims and Hypotheses
Study aims: (1) to examine whether pre-treatment PM scores predict the reduction of depressive symptoms 
at the end of treatments, (2) to determine whether an increase in PM during therapy is associated with a 

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decrease in symptom levels during 12 weeks in both treatments (3) to examine the relationship between PM 
and conceptually related and distinct concepts: self-reflection, insight, rumination, mindfulness, and self-
compassion, and if and how they are related to a reduction of symptoms in CBT and in the control 
condition, (4) to obtain neurocognitive and electrophysiologic (EEG and ERP) measures so as to further 
evaluate hypotheses that depressive disorders involve abnormalities of frontal and temporoparietal function 
(Dr. Jürgen Kayser's protocol (#6559); (5) to evaluate the prediction that treatment with CBT will result in 
acute and chronic changes in neurocognitive, EEG and ERP measures; (6) measures of left hemisphere 
processing will be predictive of clinical response to cognitive behavioral therapy; (7) to evaluate any 
interactions between psychological measures and brain variables in predicting change in symptoms during 
treatments.
Description of Subject Population
Sample #1
Specify subject population
Adults who suffer from depression
Number of completers required to accomplish study aims
130
Projected number of subjects who will be enrolled to obtain required number of completers
150
Age range of subject population
18 to 70
Gender, Racial and Ethnic Breakdown
Gender breakdown:  60% Female/40% Male
  
Ethnicity breakdown: The composition of the sample is likely to be 10% non-Hispanic African American, 
30% Hispanic/Latino, 5% other minority, and 55% non-Hispanic white.
 
Description of subject population
This pilot study will enroll 150 subjects between the ages of 18 and 70 with primary DSM-V-TR diagnosis 
of major depression.

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Recruitment Procedures
Describe settings where recruitment will occur
Recruitment will occur via referral from other mental health care professionals and physicians, and via self-
referral prompted by advertising. 
How and by whom will subjects be approached and/or recruited? 
A DES research assistant will conduct a 20-minute telephone screening interview, performed under the 
DES'#6669R to determine likely diagnostic suitability.  It includes subject's name, address, demographic 
information, source of referral, presenting problem, psychiatric history, past treatment, social history, family 
history, medical history, mental status, provisional diagnosis, and disposition.  Potentially eligible 
participants will be invited to the DES Clinic at NYSPI for a psychiatric intake evaluation and structured 
clinical interview, which will be performed under the DES’s Consent # 6669R. Informed consent will be 
obtained prior to any procedure after a subject has been found qualified both medically and diagnostically to 
participate. A full explanation of all research procedures, risks, benefits, and rights of the subject will be 
given before proceeding. Recruitment to this protocol will be restricted to  those who enroll in protocol 
#6559. Participansts in this study will need need to have EEG measures (#6559)  before 12 sessions of 
CBT and control group,  and at the end of of the 12 weeks.
How will the study be advertised/publicized? 
Online advertisements will be placed on websites that may include RecruitMe (recruit.cumc.columbia.edu, 
a  CU research site aimed at aiding recruitment of study participants), Craigslist, in sections including 
volunteers, gigs, and jobs, Google AdWords, Facebook, Research Match, academic listserv, radio, and 
others. We will advertise this study to Columbia-affiliated clinicians on the Columbia University 
PsychoPharmacology (CUPP) list-serve. We will approve through the IRB any future advertisement 
material.  
 
 
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT01868711,
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes

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Describe concurrent research involvement
Patients recruited for current protocol will also participate in protocol # 6559R.
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Depressed adults
Create or insert table to describe the inclusion criteria and methods to ascertain them
Males or females between ages 18-70 (inclusive)     Screening interview
 
Primary diagnosis of Major Depression                    SCID and clinical review
 
Beck Depression Inventory                                        BDI  ≥13 BDI
 
Hamilton Rating Scale for Depression                       HRSD ≥ 14
 
Participation in protocol #6559 
 
No psychotropic medication or over-the-counter 
antidepressant for at least one month prior to recruitment
and three months for fluoxetine.                               Clinical interview
 
Ability to give inform consent                                   Interview, the capacity to consent
 
Fluent in English Intake interview                             Self-Report
Create or insert table to describe the exclusion criteria and methods to ascertain them
Disorder or organic mental disease                             Clinical interview
 
DSM-V substance abuse or dependence within 6 months (except nicotine or
caffeine).                                                                     Toxicology, screen, intake
 
Currently taking psychotropic medication.                  Clinical interview
 
Currently receiving another type of psychotherapy      Clinical interview
or any other therapeutic intervention.
 
 
Participants who have used any of the  psychedelic drugs 
(Ketamine, Psilocybin, LSD, MDMA) 
for the current episode of depression.                           Clinical interview
 

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Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB # 
6669R
Describe Study Consent Procedures
Consent procedures are the following:
 
When subjects are eligible for the study, they will be scheduled to meet Dr. Kishon via Webex (HIPAA-
compliant teleconference) before signing a study consent form. A copy of the consent form will be provided 
to the participant before consent is obtained via encrypted email. Subjects will be accessible to an electronic 
consent form via REDCap and join a HIPAA-compliant teleconference with Dr. Kishon to discuss consent. 
Afterward, they will digitally sign the consent form with the e-signature function in REDCap. 
Indicate which of the following are employed as a part of screening or main study consent procedures
   Consent Form
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Kayser, Jurgen, PHD
Kishon Ph.D., Ronit
Type in the name(s) not found in the above list

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Study Procedures
Describe the procedures required for this study
Baseline visits
Subjects will be briefed on the newly implemented COVID-19 safety protocol to reassure them precautions 
are being taken.  This protocol is based on NYSPI COVID19 Amendment guidelines for research on April 
20 and NYSPI Remote communication guidelines for clinical care and research 3.30.20). In the current 
study, all procedures will be done remotely.
Subjects who sign the DES screening consent will be contacted within two weeks after the screening call; 
they received the diagnoses of major depressive disorder. The DES psychiatrist will approve their medical 
tests. An evaluator will rate the HRSD-17, CGI-Severity, and Beck Depression Inventory. If still eligible, 
subjects will be presented with the study consent form via REDCap and have their questions answered by 
Dr. Kishon via Webex. Once they signed the study consent form via REDCap, subjects will complete a 
battery of self-report measures in REDCap. Patients will also take part in EEG and cognitive tests 
administered under Jurgen Kayser's protocol #6559R. The patients will be randomized to the experimental 
condition of 12 sessions of CBT for depression and 12 sessions of control condition of nonspecific 
supportive treatment. CBT and supportive therapy are provided by Ph.D. student psychologists who are 
screened and interviewed by Dr. Kishon and approved and credentialed by Dr. Laura Mufson. All sessions 
will be administered via Webex. Dr. Kishon will supervise all therapists every week via Webex. 
Psychotherapy sessions will be audiotaped unless the subject does not consent; audiotaping of sessions 
is optional. The audio recording will not include the subject’s full name and will be reviewed by Dr. 
Kishon, who will evaluate the treatments provided by therapists in this study. The audio recordings will be 
kept for no more than ten years, after which they will be destroyed.
If the patient withdraws his or her consent, audio recordings can be destroyed during or after the procedure. 
The patient reserves the right to withdraw this consent at any time before or during the audiotaping. Ph.D. 
students in psychology supervised by Dr. Kishon will provide nonspecific treatment. Sessions in the control 
group will be audio recorded
 
CBT Treatment Protocol
CBT protocol represents incorporation and integration from several sources. These include (a) prior 
experience of the therapist with the treatment of depression and (b) published cognitive therapy (CBT) 
manual published by Emery (2000). The present protocol encourages therapist's flexibility in approach, yet 
during the treatment, specific tools and methods of coping with depression are given to each subject. The 
subject will learn to use the following basic cognitive-behavioral techniques for the treatment of depression: 
constructing an ‘Action Schedule’, setting goals, doing ‘behavioral experiments,’ and creating a Distorted 
Thought Record (DTR). The patient is expected to experiment with the tools between sessions.
 

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A nonspecific treatment control condition
Therapists will provide 12 sessions of support focused on the three facilitative conditions (warmth, genuine, 
and empathy). They will provide support and will assess the patients for levels of depression and suicidality 
in each session. Approved DES evaluators will administer to all patients in both groups the Hamilton Rating 
Scale for  Depression (HRSD-17) via Webex, and the CGI Severity and Improvement Scales at baseline via 
REDCap. The HRSD-17 will be administered every three weeks and at post-treatment via Webex. The CGI 
will be filled every week and at posttreatment. If there is no improvement in depressive symptoms at week 
6, the study PI will conduct an informal interview in which she will discuss with the participant alternative 
treatments. The discussion will be documented in the participant’s chart.
 
Post-Treatment Assessment Visit
Post-treatment assessment visits will occur within 12 days of the subject’s last therapy session. All baseline 
rating scales will be administered (HRSD-17, CGI) via Webex and REDCap, as well as all self-report 
measures (BDI-II, Work and Social Adjustment, TAS-20, PM, BIPM, SRIS, Treatment Credibility and The 
Expectancy of Improvement Scale, Reasons for Living, Ruminative Response Scale (RRS), The Mindful 
Attention Awareness Attention Scale(MAAS), Five-Facet Mindfulness Questionnaire (FFMQ), and Self-
Compassion Scale (SCS) via REDCap. The SCIP -M will be done via Webex. Patients will also take part in 
EEG and cognitive tests administered under Jurgen Kayser's protocol #6559R. If a patient terminates before 
completing the entire 12-session protocol, in each of the groups, this visit will be conducted as close as 
possible to the last session. Study participants who do not remit (end treatment HDRS-17 > 7, BDI-II>13) at 
the end of the trial will be offered a referral for psychotherapy or medications per subject's preference, or if 
in the control group will be offered CBT based on the availability of therapists. 
I attest to follow the COVID-19 Safety Guidelines for Columbia Psychiatry and
NYSPI Re-Entry outlined in the NYSPI Director’s June 1st memo, which includes but
are not limited to:
• Infection Control/PPE – Guidelines
• Research participants will only come on-site if absolutely necessary for the study
procedures.
• No volunteers/externs on-site during Stage 1.
• Clinical research teams will screen their participants for COVID symptoms (night
before and day of the onsite visit, documenting this in the chart), and escort them in and
out of the building.
• COVID/COVID-like symptoms in participants will be reported to the IRB via
PRISM as an SAE.
 
 
 
 
You can upload charts or diagrams if any

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Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Criteria for Early Discontinuation
The subject will be withdrawn and prematurely terminated from the study under any of the following 
circumstances:
1. The subject requests to withdraw from the study.
2. The subject exhibits a clear-cut worsening of anxiety or mood symptoms, e.g., subject whose CGI 
Improvement score rating increases to 6 (much worse) or 7 (very much worse).
3. The subject reports suicidal ideation of sufficient concern to require hospitalization. Visit the emergency 
room without admission will be judged on a case-by-case basis erring on the side of ending study 
participation.
4. The appearance of a new or undercurrent illness that prevents the patient from complying with the 
protocol.
5. The subject has missed four sessions or is not responding to repeated attempts to contact him or her. 
Careful medical and psychiatric screening would be conducted to identify patients with risk for potential 
adverse events if they were to participate in the study treatments. As examples, patients for whom suicide is 
considered a significant risk will be excluded from all study participation, and subjects with uncontrolled 
mental impairment.
Any patient who evidences significant clinical deterioration, such as unusually high levels of distress or 
suicidality at significant risk during the treatments will be removed from the study and treated with 
alternative and appropriate clinical care at the DES until referred to another treatment. Signs of deterioration 
will be monitored weekly by the protocol therapist and PI of the study. At each visit during the 12 weeks of 
the treatments, the clinician will monitor, via clinical interview and various assessment measures for signs 
of increased severity of depression or the emergence of a major depressive episode. If in the judgment of the 
clinician and the PI removal of a participant from the study is indicated due to increased severity of 
depression, the patient will be removed and treated by the study PI (Ronit Kishon) until appropriate referrals 
will set in place. The threshold for mandatory removal from the study is a CGI Global Improvement score 
of 6 or 7 (worse to very much worse). Such ratings at any evaluation would prompt premature termination. 
However, clinicians and patients can end the study at any time; i.e. a CGI-GI score > 6 is not required to 
remove a patient from the study.
Assessment Instruments

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Create a table or give a brief description of the instruments that will be used for assessment
Screening Visit:
Structured Clinical Interview for DSM-V (SCID-V) (2 hours)
Iowa Personality Disorder Screen (7 minutes)
Global Impressions Index: Severity Scale (CGI) (5 minutes)
 
Total time = 2 hours 12 minutes
 
Baseline Visit
HAM-D (15 minutes)
CGI - Severity (1 minute)
Beck Depression Inventory-II (BDI-II) (5 minutes)
Twenty Item Toronto Alexithymia Scale (TAS-20) (5 minutes) 
Work and Social Adjustment Scale (5 minutes)
Reasons for Living Scale (5 minutes)
Psychological Mindedness Scale (PM Scale) (5 minutes)
The Balanced Index of Psychological Mindedness (5 minutes)
The Self Reflection and Insight Scale (5 minutes)
The Ruminative Response Scale (RRS) (5 minutes)
The Mindful Attention Awareness Scale (MAAS) (5 minutes) 
Five Facet Mindfulness Questionnaire (FFMQ) (5 minutes)
Self Compassion Scale (SCS) (5 minutes)
Structured Clinical Interview for Psychological Mindedness (SCIP-M). (45 min)
Parental socioeconomic status (SES) (15 min)
Emotional Regulations Questionnaire (ERQ) (15 min)
Brunel Lifestyle Physical Activity Questionnaire  (10 min)
The Pittsburgh Sleep Quality Index (10 min)
Social Adjustment Scale (10 min)
EEG and cognitive tests were administered under Jurgen Kayser's protocol #6559R (2.5 hrs).
 
 
Total time = 4 hours and 30 minutes.
 
During-Session Process Measures (week 2, 6, 12)
Treatment credibility and Expectancy of Improvement Scale (3 minutes)
The Working Alliance Inventory (7 minutes)
 
Total time =10 minutes.
 
Evaluation of depressive symptoms every 3 weeks:
HAM-D (10 minutes)
 
Mid and Post-treatment Assessments (week 6, 12)
HAM-D (10 minutes) CGI - Severity (2 minutes)
Beck Depression Inventory-II (BDI-II) (5 minutes)

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Twenty Item Toronto Alexithymia Scale (TAS-20) (5 minutes)
Work and Social Adjustment Scale (5 minutes)
Reasons for Living Scale (5 minutes)
Psychological Mindedness Scale (PM Scale) (5 minutes)
The Balanced Index of Psychological Mindedness (5 minutes) 
The Self-reflection and Insight Scale (5 minutes)
The Ruminative Response Scale (RRS) (5 minutes)
The Mindful Attention Awareness Scale (MAAS) (5 minutes) 
Five Facet Mindfulness Questionnaire (FFMQ) (5 minutes)
Self-Compassion Scale (5 minutes)
Structured Clinical Interview for Psychological Mindedness (SCIP-M). (45 min)
Parental socioeconomic status (SES) (15 min)
Emotional Regulations Questionnaire (ERQ) (15 min)
Brunel Lifestyle Physical Activity Questionnaire  (10 min)
The Pittsburgh Sleep Quality Index (10 min)
Social Adjustment Scale (10 min)
EEG and cognitive tests were administered under Jurgen Kayser's protocol #6559R (2.5 hrs).
 
 
 
Total time = 4 hour 30 minutes
 
Please attach copies, unless standard instruments are used
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
No
Treatment to be provided at the end of the study
At the end of study participation, non-remitters will be offered appropriate referrals as clinically indicated.
They will discuss it with their therapist, and after the end of sessions will continue to meet Dr. Kishon as
needed, until an appropriate referral will put in place.
Remitters will discuss potential referrals with the therapist in the last 3 weeks of treatment. During this
period, and at the end of treatment, Dr. Kishon will be available to meet with the patient to consult on
the nature of the referral. After the subject concludes where to be referred, the project coordinator of the 
study will provide a list of referrals to the patient and will remain in contact so as to follow how the patient 
integrates with the new treatment place.
Clinical Treatment Alternatives
Clinical treatment alternatives
CBT is an accepted and empirically supported form of treatment for depression, and thus is not considered

Protocol Summary Form
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Kishon, Ronit
Page 17 of 21
experimental. Non-specific supportive treatment was also found to be effective for depression through in
smaller percentages than CBT. Subjects may want to be medicated for their depression in which case they
will appropriately be referred to during the screening/evaluation process.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
Assessment procedure: Subjects could develop mild to moderate emotional discomfort or frustration
associated with psychiatric interviewing, or filling out questionnaires. Only experienced clinicians will
administer these interviews; they are well trained and experienced in recognizing and dealing with
emotional discomfort. Also, subjects will be informed that they can end the meeting at any time, or skip
uncomfortable questions. Unless such skipped questions prevent a diagnosis or other clinical issues from
being adequately assessed, the subject will remain study eligible. Subjects’ mood symptoms may also
worsen during treatment. See procedures for minimizing risk in the next section.
 
CBT and nonspecific supportive treatments: Subjects may exhibit subjective distress during CBT or
supportive treatment, which, if it occurs, is likely to be mild and transient. We will closely monitor
reactions and address them therapeutically. In the unlikely event that a subject manifests unusually high
levels of distress, the PI will withdraw him or her from the study and provide the necessary support until a 
referral will be in place.
Describe procedures for minimizing risks
Careful medical and psychiatric screening will be conducted to identify subjects with elevated risk for
potential adverse effects. For example, participants for whom suicide is considered a significant risk will be 
excluded from the study.
 
Any subject who evidences significant clinical deterioration, such as unusually high level of distress or
suicidality at significant risk during CBT or supportive treatment, will be removed from the study and
treated with alternative and appropriate clinical care at the DES until a referral plan is set in place. Signs of
deterioration will be monitored weekly by the protocol therapist, study PI, and a psychiatrist at the DES as
needed. In addition, at each visit during the 12 weeks of CBT and control group, the treating clinician will 
monitor various assessment measures for signs of increased severity of depression via clinical interview. If 
in the judgment of the clinician and the PI, the removal of a participant from the study is indicated due to
increased severity of depression, the patient will be removed and treated until the referral is in place or
clinically indicated. The threshold for mandatory removal from the study is a CGI Global Improvement
score of 6 or 7 (worse to very much worse). Such ratings at any evaluation would prompt premature
termination. However, clinicians and subjects can end the study at any time; i.e., a CGI-GI score > 6 is not 
required to remove a subject from the study. 
 
Precautionary measures will be taken to prevent the transmission of COVID-19 in experimental processes. 
The changes we proposed in the amendment section will minimize the subjects' infection risk for COVID-
19. We are minimizing risks of in-person visits by conducting 12 virtual CBT sessions and 12 virtual control 
group therapy sessions. All self-report measures and interviews measures will be done remotely. 

Protocol Summary Form
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Kishon, Ronit
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Methods to Protect Confidentiality
Describe methods to protect confidentiality
All collected data will be kept confidential and used for research purposes only. Patient charts and hard copy 
data will be held in locked file cabinets and identifiable only by number and a naming code of initials. 
Access to research records is restricted to research staff and regulatory authorities. No research participant’s 
identifying data will be published. All electronic records will be kept confidential to the extent permitted by 
law. Participant’s names and other personal identifying information will be stored in an electronically secure 
database at the New York State Psychiatric Institute on a registered password-protected computer. The 
information may be accessed only by the PI and the research coordinator. The study Data Manager will 
manage a data file on SPSS that has all study data without identifying information. Patients’ names will not 
be entered into the study database, and each will be uniquely identified only by the ID number. All data will 
be entered once but checked and audited by two different staff members. When data entry is complete, all 
data will be cleaned and rechecked for accuracy before being backed up on an encrypted flash drive. Any 
data that is transmitted electronically will be fully encrypted and password protected.
 
Due to remote administration of intake evaluation procedure, therapy sessions, clinical interviews through 
sessions,  and self-report measures at pretreatment, mid-treatment, and post-treatment, confidentiality is 
protected through  HIPAA-compliant videoconferencing and web-based platforms, and encrypted email 
communication. 
 
 
 
 
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
All participants will receive a complete medical and psychiatric evaluation, and the PI will share the
necessary information with the participant.
Benefits to participants are direct (i.e., treatment of depression; amelioration of symptoms). Also, some
participants may experience relief of their depressive symptoms.
Compensation and/or Reimbursement 

Protocol Summary Form
6806R
Kishon, Ronit
Page 19 of 21
Will compensation or reimbursement for expenses be offered to subjects?
No
References
References
 
Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using Self-Report Assessment
Methods to Explore Facets of Mindfulness. Assessment, 13(1), 27-45. doi: 10.1177/1073191105283504
 
Barnard, L. K., & Curry, J. F. (2011). Self-compassion: Conceptualizations, correlates, & interventions.
Review of General Psychology, 15(4), 289-303. doi: 10.1037/a0025754
 
Beitel, M., Ferrer, E., & Cecero, J. J. (2005). Psychological mindedness and awareness of self and others.
Journal of Clinical Psychology, 61(6), 739-750. doi: 10.1002/jclp.20095
 
Brown, K. W., & Ryan, R. M. (2003). The benefits of being present: Mindfulness and its role in
psychological well-being. Journal of personality and social psychology, 84(4), 822-848. doi: 10.1037/0022-
3514.84.4.822
 
Bruder, Kayser, J., Tenke, C.E. (2012). Event-related brain potentials in depression: Clinical, cognitive and
neurophysiologic implications. In S.J. Luck & E.S. Kappenman (Eds.), The Oxford Handbook of
EventRelated Potential Components (pp. 563-592). New York: Oxford University Press.
 
Conte, H. R., Ratto, R., & Karasu, T. B. (1996). The Psychological Mindedness Scale: Factor structure and
relationship to outcome of psychotherapy. Journal of Psychotherapy Practice and Research, 5, 250–259.
 
Diedrich, A., Grant, M., Hofmann, S. G., Hiller, W., & Berking, M. (2014). Self-compassion as an emotion 
regulation strategy in major depressive disorder. Behaviour Research and Therapy, 58, 43-51. doi:
http://dx.doi.org/10.1016/j.brat.2014.05.006
 
Farber, B. A., & Golden, V. (1997). Psychological-mindedness in psychotherapists.
In M. McCaUum & W. Piper (Eds.), Psychological- mindedness. Hillsdale, NJ: Erlbaum.
 
Fenigstein, A., Scheier, M.F., & Buss, A.H. (1975). Public and private self- consciousness: Assessment and 
theory. Journal of counseling and Clinical Psychology, 43, 522-527.
 
Grant, A. M. (2001). Rethinking psychological mindedness: Metacognition self-reflection and insight.
Behavior Change, 18(1), 8-17.
 
Grant, A. M., Franklin, J., & Langford, P. (2002). The self-reflection and insight scale: A new measure of
private self-consciousness. Social Behavior and Personality: an international journal, 30(8), 821-835.
 

Protocol Summary Form
6806R
Kishon, Ronit
Page 20 of 21
Hollon, S.D., Shelton, R. C., Wisniewski, S. et al. (2006). Presenting characteristics of depressed outpatients 
as a function of recurrence: preliminary findings from the STAR*D clinical trial. Journal of Psychiatric 
Research, February 40 (1), 59-69
 
Kayser, J., Tenke, C.E., Abraham, K.S., Alschuler, D.M., Alvarenga, J.E., Skipper, J., Warner, V., Bruder,
G.E., & Weissman, M.M. (2017). Motivated attention and family risk for depression: Neuronal generator
patterns at scalp elicited by lateralized aversive pictures reveal blunted emotional responsivity. NeuroImage: 
Clinical, 14, 692-707.
MacBeth, A., & Gumley, A. (2012). Exploring compassion: A meta-analysis of the association between
self-compassion and psychopathology. Clinical Psychology Review, 32(6), 545-552. doi:
http://dx.doi.org/10.1016/j.cpr.2012.06.003
 
Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and
Identity, 2(3), 223-250.
 
Nolen-Hoeksema, S. (2000). The role of rumination in depressive disorders and mixed anxiety/depressive
symptoms. Journal of Abnormal Psychology, 109(3), 504-511. doi: 10.1037/0021-843x.109.3.504
 
Nyklíček, I., & Denollet, J. (2009). Development and evaluation of the Balanced Index of Psychological
Mindedness. Psychological Assessment, 21, 32–44.
 
Trapnell, P. D., & Campbell, J. D. (1999). Private self-consciousness and the five-factor model of
personality: Distinguishing rumination from reflection. Journal of personality and social psychology, 
76(2),284-304. doi: 10.1037/0022-3514.76.2.284
Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination reconsidered: A psychometric
analysis. Cognitive Therapy and Research, 27(3), 247-259. doi: 10.1023/a:1023910315561
 
Watkins, E. R. (2008). Constructive and unconstructive repetitive thought. Psychological Bulletin, 134(2),
163-206. doi: 10.1037/0033-2909.134.2.163
 
 
 
Uploads
Upload the entire grant application(s)
Upload copy(ies) of unbolded Consent Form(s)
Consent form non bolded 8_27_2021docx.pdf
Upload copy(ies) of bolded Consent Form(s)
Consent form bolded 8_27_2021docx.pdf
Upload copy(ies) of recruitment materials/ads to be reviewed

Protocol Summary Form
6806R
Kishon, Ronit
Page 21 of 21
Recruit me non bolded blurb 8_27_21_.pdf
Recruit me bolded blurb 8_27_21_.pdf
BriefPoster_Example_8_27_21 final.pdf
Upload copy(ies) of the HIPAA form
HIPPA Form October , 2017.pdf
Upload any additional documents that may be related to this study
Consent form undbolded 8_21_2021docx.pdf

 
 
Twelve Weeks of Cognitive Behavior Therapy (CBT) vs. Supportive Therapy for 
Depression 
Sponsor:  
National Institute of Mental Health 
Enrolling:  
Male and Female Patients 
Study Length:  15 Weeks 
Clinic Visits:  3 visits in person 
Age Range:  Between 18 and 65 years old 
IRB Number:  6806R 
US Government ID: NCT01868711 
Contact:  
 Ronit Kishon Ph.D.: 646 724 4171       Tayler.Wilson@nyspi.columbia.edu 
 
Additional Study Information: 
      This study offers 12 individual free sessions of Cognitive Behavior Therapy (CBT) or 
Supportive Therapy to people who suffer from depression. All sessions will be administered 
virtually using HIPAA-compliant video teleconferencing. Participants must have access to the 
internet and have video conferencing capabilities. During the study, participants can’t be on 
psychotropic medications nor attend any other psychotherapy. Participants will need to come in 
person once for a urine & blood test (protocol #6669) and twice for an electroencephalogram 
(EEG) (protocol #6559). Please exercise caution when traveling in public and follow public 
health guidelines, such as wearing masks in public and avoiding crowds. It is important for you 
to stay informed of public health recommendations and guidelines regarding COVID-19, such as 
those issued by the Centers for Disease Control (CDC.gov) and local governments. If you have 
questions or do not feel safe traveling, please let us know, and know that you can call to 
reschedule visits. 
      CBT is a well-established psychotherapy for depression. CBT’s primary goal is to provide 
specific tools and methods of depression management. The primary goal of supportive 
psychotherapy is to strengthen the patient’s ability to cope effectively with various life stressors. 
The purpose of this research study is to learn which psychophysiological and psychological 
variables predict who will benefit from each treatment and how these variables may change 
throughout therapy. 
      Participants are randomized to one of these groups and are required to fill out measures that 
assess various psychological variables at three-time points through 12 weeks of treatment in 
addition to shorter measures throughout the treatment. These measures will be filled out online 
using HIPPA-compliant platforms. We will assist you in accessing and filling out those measures 
online. We plan to recruit 60 participants with depression who will complete the psychotherapy, 
study forms, and EEG.  

 
 
Twelve Weeks of Cognitive Behavior Therapy (CBT) vs. Supportive Therapy for 
Depression 
Sponsor:  
National Institute of Mental Health 
Enrolling:  
Male and Female Patients 
Study Length:  15 Weeks 
Clinic Visits:  3 visits in person 
Age Range:  Between 18 and 65 years old 
IRB Number:  6806R 
US Government ID: NCT01868711 
Contact:  
 Ronit Kishon Ph.D.: 646 724 4171       Tayler.Wilson@nyspi.columbia.edu 
 
Additional Study Information: 
      This study offers 12 individual free sessions of Cognitive Behavior Therapy (CBT) or 
Supportive Therapy to depressed adults. All sessions will be given virtually using Zoom. 
Participants must have internet access and video conferencing capabilities. During the study, 
participants can't be on psychotropic medications or attend any other psychotherapy. Participants 
will need to come in person before receiving sessions for a urine & blood test (protocol #6669) 
and once before and once after sessions for an EEG (protocol #6559). Please exercise caution 
when traveling in public and follow public health guidelines, such as wearing masks in public 
and avoiding crowds. In addition, you need to stay informed of public health recommendations 
and guidelines regarding COVID-19, such as those issued by the CDC (CDC.gov) and local 
governments. If you have questions or do not feel safe traveling, please let us know, and know 
that you can call to reschedule visits. CBT is well-established psychotherapy for depression. 
CBTs primary goal is to provide specific tools and methods of depression management. 
Supportive Psychotherapy's primary goal is to strengthen the patient's ability to cope effectively 
with various life stressors. The purpose of this research study is to learn which variables 
predict who will benefit from each treatment and how these variables may change 
throughout therapy. Participants are randomly assigned to receive one of the two therapies 
and are required to fill out forms weekly through the 12 weeks of treatment. These forms 
will be filled out online using HIPPA-compliant platforms. We plan to recruit 60 
participants with depression who will complete the psychotherapy, study forms, and EEG. 
 

 
We offer 12 free online psychotherapy 
sessions focused on treating depression 
 
We are seeking adult study participants that 1) are depressed, 
2) not on antidepressants (prescribed or over-the-counter), 
3) not currently receiving psychotherapeutic treatment. 
 
Participants will attend 12 therapy sessions over 12 weeks, and come to 
our laboratory three times: once for a blood and urine screen, and twice 
for EEG (brainwave) testing. There are no costs for the psychotherapy 
sessions nor is there any financial compensation for study participation. 
 
 
For full details please call or email: 
646 774 8030 Ronit.Kishon@nyspi.columbia.edu 
 
Research Study Psychotherapy for 
Depression at Columbia University 

 
 
 
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1
        
 
 
Consent Summary Page 
  
• 
Overview 
Below is a summary of the study that you are asked to participate in. This outline is meant to be a guide for you to 
use while considering the study and reading the consent form.  It is not meant to replace the consent form, which 
you will have to sign if you decide to participate in the study.  The consent form contains detailed information 
about the study and about the risks which you will need to consider before making your decision.  Read the 
consent form carefully and discuss it with others before deciding to take part.  And remember that, even if you 
agree to participate,  you can change your mind at any time.  
The purpose of the study is to compare two forms of therapy for depression Cognitive Behavior Therapy (CBT) 
and Nonspecific supportive treatment, and examine whether their effectiveness relates to concepts about self and 
others. In each therapy you will receive 12 individual sessions. You will not be able to choose which therapy you 
will receive but both are considered effective for treating depression. Precautionary measures will be taken to 
prevent the transmission of COVID-19 in experimental processes. Most of your visits will be conducted remotely 
using the telephone or HIPAA-compliant video teleconferencing. 
 
• 
Voluntary 
As with all research, this is a voluntary study, and you do not have to participate if you do not want to.  Also, you 
may stop participating at any time. 
 
• 
Alternative Treatments/Alternatives to Participation 
Medications, interpersonal psychotherapy (IPT), dialectic behavior therapy (DBT), group therapy. 
 
• 
Procedures 
1. Evaluation for Major Depression Disorder (remote session). 
2. Self-report study measures (beginning, midpoint, end) done online. 
3. EEG and cognitive tests (beginning and end) done in the lab at NYSPI. 
4. 12 weekly sessions of Cognitive Behavior Therapy for Depression or 12 weekly sessions of Supportive 
Therapy for Depression(remote sessions). 
5. Participants cannot be on psychotropic medications during the study. Medicating for depression will not be 
part of this study.  
6. Participants will be interviewed about symptoms of depression every 3 weeks, and will fill a self-report 
measure on their symptoms every week (remote sessions, and measures done online). 
 
• 
Risks and Inconveniences 
This study includes some risks and discomforts (please refer to the consent form for further details and 
explanations of these risks).  These include no change of your depressive symptoms. Sometimes psychotherapy 
might increase sadness and anxiety.  
You should exercise caution when traveling in public and follow public health guidelines, such as wearing masks 
in public and avoiding crowds. It is important for you to stay informed about public health recommendations and 
guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local 
government guidelines and directives. If you have questions about how you will travel for appointments, or do not 
feel safe traveling, please let us know, and be advised that you can call to reschedule visits 
 
• 
Benefits 
Although some benefit is possible such as reduction of depressive symptoms, you may not have any benefit if the 
treatment is not effective.  
 
• 
Questions 
You may contact the study principal investigator, Ronit Kishon, at 646 724 4171 with any question 
 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
2
 
 
 
 
CONSENT FORM Study # 6806R 
Cognitive Behavior Therapy for Depression 
 
 
Purpose and Overview 
The purpose of the study is to compare two forms of therapy for depression since we still can’t predict 
which one will be more helpful for a particular person. Previous studies suggested that Cognitive 
Behavior Therapy (CBT) is an effective treatment for depression in nearly half of the individuals who 
do it, however there are others who do not benefit from it. Nonspecific supportive treatment focuses 
on meeting with a therapist, receiving support, having one's hope restored, and overcoming 
demoralization. In each of the treatments you will receive12 virtual sessions. You will be randomly 
assigned to one or the other. The purpose of this study is to explore whether your concepts about 
yourself and others are related to the effectiveness of each of the treatments. Also, you must enroll 
in Dr. Kayser's study (#6559) for the purpose of behavioral and electrophysiological tests at two time 
points that will contribute to our study. The aim is to learn more about brain function in people who 
are depressed and receive different types of talk therapy. 
 
 
Voluntary 
Participation in this research study is voluntary. If you decide not to participate, or if you later decide 
to stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not 
to participate or withdraw your participation will not affect your current or future treatment at the New 
York State Psychiatric Institute or Columbia University Medical Center. If you are determined to be 
eligible for the study and later stop your participation for any reason, the study principal investigator, 
Dr. Kishon will treat you until the appropriate referral will be in place. You will be notified of significant 
new findings that may relate to your willingness to continue to participate in the study. 
 
 
Alternative Treatments/ Alternatives to Participation 
You do not have to participate in this study to receive treatment for your depression. CBT and 
nonspecific supportive therapy can be obtained outside of study participation. There are medications 
that have been shown to be effective for depression and can be prescribed by your regular physician. 
There are also other non-medication treatments for depression beside CBT such as interpersonal 
psychotherapy, or group therapy. 
 
 
Procedures 
Precautionary measures will be taken to prevent the transmission of COVID-19 in experimental 
processes. All  your visits in this protocol will be conducted remotely using the telephone or HIPAA-
compliant video teleconferencing. In this study most of the evaluation process and all psychotherapy 
sessions will be done virtually. We will discuss with you the technology HIPAA-compliant platforms to 
be used and any concerns you may have, such as access to a private space in which to take calls, or 
accessibility—access at home to adequate devices, cell signal, or Wi-Fi. In the CBT treatment, you will 
receive 12 weekly remote psychotherapy sessions that last about 50 minutes each. The treatment 
involves being asked questions about your thoughts and feelings, as well as learning skills to manage 

 
 
 
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3
them. In nonspecific supportive therapy you will also receive 12 sessions that last 50 minutes each.  
In the sessions you will receive support and understanding for your problems, so to have your hope  
restored and to overcome demoralization. 
 
Study measures:  
You will be interviewed remotely and you will fill some self-report measures online  for a total of an hour 
and 15 minutes before treatment, in week 6, and after 12 weeks when the treatment is completed. We 
will also ask you before each session to fill a self-report measure that takes 5 minutes so we can 
monitor your symptoms. Every 3 weeks we will interview you for 15 minutes, again with the intention of 
monitoring your level of symptoms. The brain tests will be administered in Dr. Kayser’s study( #6559).  
 
Medications during the study:  
You can participate in the study if you did not take prescribed antidepressant, or over the counter 
antidepressant medications, in the past month (three months for fluoxetine). You will be able to 
continue receiving psychotherapy sessions in the study if your clinical condition will initiate your outside 
physician to prescribe psychotropic medications. 
 
The study doctors will end your study participation if they determine it is no longer in your best interest. 
In addition, you may stop participating in this study at any time for any reason. If you stop participating 
in the study before 12 weeks end, the study principal investigator, Dr. Kishon, will continue to see you  
for sessions until an appropriate referral will be made. Completion of the study is not required for you to  
receive these sessions by Dr. Kishon. 
 
Cognitive Behavior Therapy and Nonspecific Supportive Therapy – Audiotaping: 
You  will be audiotaped during your treatment visits. The audiotaping is optional. The audio recording 
will be used for education, research or training purposes only. Any audio recording will not include your 
full name, and will be reviewed by Dr. Kishon who will evaluate the treatment provided by therapists in 
this study. The audio recordings are kept for no more than 10 years after which they will be destroyed. 
If you withdraw your consent, audio recordings can be destroyed during or after the interview or 
procedure. 
 
Treatment After the End of the Study:  
After the study is over, the Principal Investigator, Dr. Kishon, will meet with you, and answer any 
questions you may have. If after completion of the study you have not improved, you will receive 
referrals for continuation of psychotherapy and/or medications. You will be able to see Dr. Kishon for 
weekly sessions until the referral is in place.  
 
Investigator Initiated Discontinuation of Study:  
There may be times when the investigator carrying out this study decides to stop the study even 
though you may wish to continue to participate. Examples include missing 4 number of sessions or not 
responding to repeated attempts to contact you. 
 
Risks and Inconveniences 
The primary risk of participating in this study is that the treatment may not help your symptoms. If you 
do not improve it may be up to 12 weeks from the time you enter the study until you would be provided 
with another type of treatment. Therefore, if you do not improve, participating in this study will delay your  
receiving treatment for up to 12 weeks with medications and other psychotherapies known to be helpful. 
The risks of psychotherapy treatment include the possibility of increased anxiety or sadness, and the 
therapists will try to help you with that if it occurs. We anticipate that the risks of study participation are 

 
 
 
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4
no greater than those encountered in routine clinical treatment. However, you may be withdrawn from 
the study and offered other treatment. 
 
Benefits: 
A direct benefit to you is the possibility that the treatments will help your symptoms of depression. In 
addition, your participation may help researchers learn more about how to treat depression. There may 
be no benefit to you if the treatment is not effective. 
 
The knowledge gained from this study may contribute to a better understanding of psychiatric disorders,  
and it may contribute to the development of objective measures for diagnosis and treatment selection. 
 
Confidentiality 
All records will be stored in locked files and will be kept confidential to the extent permitted by law. 
Records will be available to research staff, and to Federal, State and Institutional regulatory personnel 
(who may review records as part of routine audits). 
 
Your name and other personal identifying information will be stored in an electronically secure database 
at New York State Psychiatric Institute. Research data that is entered into the computer will be stored 
according to study ID. A master list linking the patient name to the assigned ID is kept in a separate file.  
In order to access, the computer and appropriate data files, the staff member must know have 
knowledge of the password and be given rights to access the data by the data manager. 
All data that is transmitted via computer is encoded and identifying information is removed. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
Your private information could be used for future research studies or distributed to 
another investigator for future research studies, with or without identifiers. Should any of the information 
gathered from you be used for scientific publications or presentations, you will be protected through the 
use of a system of codes that will not reveal the identity of individuals. Any report based on this study 
will only be used as grouped information without mention or description of the individual participants. 
 
The NYSPI Remote Communications Guidance will be followed to ensure protection of 
confidentiality. This discussion and documentation of consent is carried out in a HIPAA – compliant 
teleconference as well as the psychotherapy sessions. Instruments to be completed  
will be completed via REDCap, a HIPAAA-compliant platform to ensure confidentiality. Our research 
assistants will assist you in using those platforms.  
 
In case of Injury 
Federal regulations require that we inform participants about our institution's policy with regard to 
compensation and payment for treatment of research-related injuries. If you believe that you have 
sustained an injury as a result of participating in a research study, you may contact the Principal 
Investigator Dr. Ronit Kishon at 646-724-4171 so that you can review the matter and identify the 
medical resources that may be available to you. 
 
In case of injury, New York State Psychiatric Institute will provide short-term emergency medical 
treatment, which has been determined to be necessary by New York State Psychiatric Institute's 
doctors, and which is within the capability of New York State Psychiatric Institute to provide. In addition, 
we will provide assistance in arranging follow up care in such instances. 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
5
 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide 
compensation or payment for treatment of research related injuries. However, you should be aware that 
you do not give up your legal right to seek such compensation through the court by participating in this 
research. 
 
 
Questions 
Dr. Kishon will answer to the best of her ability any questions that the participant may have now or in the 
future about the research procedures, or about the subject's response to the procedures. She can be  
 
reached during the day, and outside of regular business hours at 646-724-4171. Dr. Kishon can be 
called outside of regular business hours for important issues that should not wait until the next business 
day. In the case of an EMERGENCY go to your nearest emergency room and call Dr. 
Kishon. 
 
If you have any questions about your rights as a research participant, want to provide feedback, or have  
a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a committee that 
protects the rights of participants in research studies). You may call the IRB Main Office at (646)774-
7155 during regular office hours. 
 
You will be given a copy of the signed Consent Form.

 
                                                          08/26/2020 
                                                                                                                                                                                 
 
 
Documentation of Consent 
 
I voluntarily agree to participate in the research study described above.  
 
 
 
Name:___________________________  (print) 
 
Signed __________________________    Study Participant 
 
Date: __________________________ 
 
 
I have discussed the proposed research with this participant including the risks, 
benefits, and alternatives to participation (including the alternative of not participating in 
the research). The participant has had an opportunity to ask questions and in my 
opinion is capable of freely consenting to participate in this research. 
 
 
 
Name: ______________________   (print) 
 
 
 
 
 
 
 
 
Signed: 
 
_____________ Person Designated to Obtain Consent 
 
 
 
 
Date:___________  
 

 08/20/2021 
Consent Summary Page 
•
Overview
Below is a summary of the study that you are asked to participate in. This outline is meant to be a guide for you to 
use while considering the study and reading the consent form.  It is not meant to replace the consent form, which 
you will have to sign if you decide to participate in the study.  The consent form contains detailed information 
about the study and about the risks which you will need to consider before making your decision.  Read the 
consent form carefully and discuss it with others before deciding to take part.  And remember that, even if you 
agree to participate,  you can change your mind at any time.  
The purpose of the study is to compare two forms of therapy for depression Cognitive Behavior Therapy (CBT) 
and Nonspecific supportive treatment, and examine whether their effectiveness relates to concepts about self and 
others. In each therapy you will receive 12 individual sessions. You will not be able to choose which therapy you 
will receive but both are considered effective for treating depression. Precautionary measures will be taken to 
prevent the transmission of COVID-19 in experimental processes. Most of your visits will be conducted remotely 
using the telephone or HIPAA-compliant video teleconferencing. 
•
Voluntary
As with all research, this is a voluntary study, and you do not have to participate if you do not want to.  Also, you 
may stop participating at any time. 
•
Alternative Treatments/Alternatives to Participation
Medications, interpersonal psychotherapy (IPT), dialectic behavior therapy (DBT), group therapy. 
•
Procedures
1. Evaluation for Major Depression Disorder (remote session).
2. Self-report study measures (beginning, midpoint, end) done online.
3. EEG and cognitive tests (beginning and end) done in the lab at NYSPI.
4. 12 weekly sessions of Cognitive Behavior Therapy for Depression or 12 weekly sessions of Supportive
Therapy for Depression(remote sessions).
5. Participants cannot be on psychotropic medications during the study. Medicating for depression will not be
part of this study.
6. Participants will be interviewed about symptoms of depression every 3 weeks, and will fill a self-report
measure on their symptoms every week (remote sessions, and measures done online).
•
Risks and Inconveniences
This study includes some risks and discomforts (please refer to the consent form for further details and 
explanations of these risks).  These include no change of your depressive symptoms. Sometimes psychotherapy 
might increase sadness and anxiety.  
You should exercise caution when traveling in public and follow public health guidelines, such as wearing masks 
in public and avoiding crowds. It is important for you to stay informed about public health recommendations and 
guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local 
government guidelines and directives. If you have questions about how you will travel for appointments, or do not 
feel safe traveling, please let us know, and be advised that you can call to reschedule visits 
•
Benefits
Although some benefit is possible such as reduction of depressive symptoms, you may not have any benefit if the 
treatment is not effective.  
•
Questions
You may contact the study principal investigator, Ronit Kishon, at 646 724 4171 with any question 

 
 
 
                                                                                                                                                       08/20/2021 
 
 
 
 
CONSENT FORM Study # 6806R 
Cognitive Behavior Therapy for Depression 
 
 
Purpose and Overview 
The purpose of the study is to compare two forms of therapy for depression since we still can’t predict 
which one will be more helpful for a particular person. Previous studies suggested that Cognitive 
Behavior Therapy (CBT) is an effective treatment for depression in nearly half of the individuals who 
do it, however there are others who do not benefit from it. Nonspecific supportive treatment focuses 
on meeting with a therapist, receiving support, having one's hope restored, and overcoming 
demoralization. In each of the treatments you will receive12 virtual sessions. You will be randomly 
assigned to one or the other. The purpose of this study is to explore whether your concepts about 
yourself and others are related to the effectiveness of each of the treatments. Also, you will be asked 
to consent to participate in Dr. Kayser's study (#6559) for the purpose of behavioral and 
electrophysiological tests at two time points that will contribute to our study. The aim is to learn more 
about brain function in people who are depressed and receive different types of talk therapy. 
 
 
Voluntary 
Participation in this research study is voluntary. If you decide not to participate, or if you later decide 
to stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not 
to participate or withdraw your participation will not affect your current or future treatment at the New 
York State Psychiatric Institute or Columbia University Medical Center. If you are determined to be 
eligible for the study and later stop your participation for any reason, the study principal investigator, 
Dr. Kishon will treat you until the appropriate referral will be in place. You will be notified of significant 
new findings that may relate to your willingness to continue to participate in the study. 
 
 
Alternative Treatments/ Alternatives to Participation 
You do not have to participate in this study to receive treatment for your depression. CBT and 
nonspecific supportive therapy can be obtained outside of study participation. There are medications 
that have been shown to be effective for depression and can be prescribed by your regular physician. 
There are also other non-medication treatments for depression beside CBT such as interpersonal 
psychotherapy, or group therapy. 
 
 
Procedures 
Precautionary measures will be taken to prevent the transmission of COVID-19 in experimental 
processes. All  your visits in this protocol will be conducted remotely using the telephone or HIPAA-
compliant video teleconferencing. In this study most of the evaluation process and all psychotherapy 
sessions will be done virtually. We will discuss with you the technology HIPAA-compliant platforms to 
be used and any concerns you may have, such as access to a private space in which to take calls, or 
accessibility—access at home to adequate devices, cell signal, or Wi-Fi. In the CBT treatment, you will 
receive 12 weekly remote psychotherapy sessions that last about 50 minutes each. The treatment 
involves being asked questions about your thoughts and feelings, as well as learning skills to manage 

 
 
 
                                                                                                                                                       08/20/2021 
them. In nonspecific supportive therapy you will also receive 12 sessions that last 50 minutes each. In 
the sessions you will receive support and understanding for your problems, so to have your hope  
 
restored and to overcome demoralization. 
 
Study measures:  
You will be interviewed remotely and you will fill some self-report measures online  for a total of an hour 
and 15 minutes before treatment, in week 6, and after 12 weeks when the treatment is completed. We 
will also ask you before each session to fill a self-report measure that takes 5 minutes so we can 
monitor your symptoms. Every 3 weeks we will interview you for 15 minutes, again with the intention of 
monitoring your level of symptoms. The brain tests will be administered in Dr. Kayser’s study( #6559).  
 
Medications during the study:  
You can participate in the study if you did not take prescribed antidepressant, or over the counter 
antidepressant medications, in the past month (three months for fluoxetine). You will be able to 
continue receiving psychotherapy sessions in the study if your clinical condition will initiate your outside 
physician to prescribe psychotropic medications. 
 
The study doctors will end your study participation if they determine it is no longer in your best interest. 
In addition, you may stop participating in this study at any time for any reason. If you stop participating 
in the study before 12 weeks end, the study principal investigator, Dr. Kishon, will continue to see you  
for sessions until an appropriate referral will be made. Completion of the study is not required for you to  
receive these sessions by Dr. Kishon. 
 
Cognitive Behavior Therapy and Nonspecific Supportive Therapy – Audiotaping: 
You  will be audiotaped during your treatment visits. The audio recording will be used for education, 
research or training purposes only. Any audio recording will not include your full name, and will be 
reviewed by Dr. Kishon who will evaluate the treatment provided by therapists in this study. The audio 
recordings are kept for no more than 10 years after which they will be destroyed. If you withdraw your 
consent, audio recordings can be destroyed during or after the interview or procedure. 
 
Treatment After the End of the Study:  
After the study is over, the Principal Investigator, Dr. Kishon, will meet with you, and answer any 
questions you may have. If after completion of the study you have not improved, you will receive 
referrals for continuation of psychotherapy and/or medications. You will be able to see Dr. Kishon for 
weekly sessions until the referral is in place.  
 
Investigator Initiated Discontinuation of Study:  
There may be times when the investigator carrying out this study decides to stop the study even 
though you may wish to continue to participate. Examples include missing 4 number of sessions or not 
responding to repeated attempts to contact you. 
 
Risks and Inconveniences 
The primary risk of participating in this study is that the treatment may not help your symptoms. If you 
do not improve it may be up to 12 weeks from the time you enter the study until you would be provided 
with another type of treatment. Therefore, if you do not improve, participating in this study will delay your  
receiving treatment for up to 12 weeks with medications and other psychotherapies known to be helpful. 
The risks of psychotherapy treatment include the possibility of increased anxiety or sadness, and the 
therapists will try to help you with that if it occurs. We anticipate that the risks of study participation are 

 
 
 
                                                                                                                                                       08/20/2021 
no greater than those encountered in routine clinical treatment. However, you may be withdrawn from  
 
 
the study and offered other treatment. 
 
Benefits: 
A direct benefit to you is the possibility that the treatments will help your symptoms of depression. In 
addition, your participation may help researchers learn more about how to treat depression. There may 
be no benefit to you if the treatment is not effective. 
 
The knowledge gained from this study may contribute to a better understanding of psychiatric disorders,  
and it may contribute to the development of objective measures for diagnosis and treatment selection. 
 
Confidentiality 
All records will be stored in locked files and will be kept confidential to the extent permitted by law. 
Records will be available to research staff, and to Federal, State and Institutional regulatory personnel 
(who may review records as part of routine audits). 
 
Your name and other personal identifying information will be stored in an electronically secure database 
at New York State Psychiatric Institute. Research data that is entered into the computer will be stored 
according to study ID. A master list linking the patient name to the assigned ID is kept in a separate file.  
In order to access, the computer and appropriate data files, the staff member must know have 
knowledge of the password and be given rights to access the data by the data manager. 
All data that is transmitted via computer is encoded and identifying information is removed. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
Your private information could be used for future research studies or distributed to 
another investigator for future research studies, with or without identifiers. Should any of the information 
gathered from you be used for scientific publications or presentations, you will be protected through the 
use of a system of codes that will not reveal the identity of individuals. Any report based on this study 
will only be used as grouped information without mention or description of the individual participants. 
 
The NYSPI Remote Communications Guidance will be followed to ensure protection of 
confidentiality. This discussion and documentation of consent is carried out in a HIPAA – compliant 
teleconference as well as the psychotherapy sessions. Instruments to be completed  
will be completed via REDCap, a HIPAAA-compliant platform to ensure confidentiality. Our research 
assistants will assist you in using those platforms.  
 
In case of Injury 
Federal regulations require that we inform participants about our institution's policy with regard to 
compensation and payment for treatment of research-related injuries. If you believe that you have 
sustained an injury as a result of participating in a research study, you may contact the Principal 
Investigator Dr. Ronit Kishon at 646-724-4171 so that you can review the matter and identify the 
medical resources that may be available to you. 
 
In case of injury, New York State Psychiatric Institute will provide short-term emergency medical 
treatment, which has been determined to be necessary by New York State Psychiatric Institute's 

 
 
 
                                                                                                                                                       08/20/2021 
doctors, and which is within the capability of New York State Psychiatric Institute to provide. In addition, 
we will provide assistance in arranging follow up care in such instances. 
 
 
 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide 
compensation or payment for treatment of research related injuries. However, you should be aware that 
you do not give up your legal right to seek such compensation through the court by participating in this 
research. 
 
 
Questions 
Dr. Kishon will answer to the best of her ability any questions that the participant may have now or in the 
future about the research procedures, or about the subject's response to the procedures. She can be  
 
reached during the day, and outside of regular business hours at 646-724-4171. Dr. Kishon can be 
called outside of regular business hours for important issues that should not wait until the next business 
day. In the case of an EMERGENCY go to your nearest emergency room and call Dr. 
Kishon. 
 
If you have any questions about your rights as a research participant, want to provide feedback, or have  
a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a committee that 
protects the rights of participants in research studies). You may call the IRB Main Office at (646)774-
7155 during regular office hours. 
 
You will be given a copy of the signed Consent Form. 
 
 
 
 
Documentation of Consent 
 
I voluntarily agree to participate in the research study described above.  
 
 
 
Name:___________________________  (print) 
 
Signed __________________________    Study Participant 
 
Date: __________________________ 
 
 
 
 
 
 
 
 

IRB # 6806R 
  
 
I have discussed the proposed research with this participant including the risks, benefits, and 
alternatives to participation (including the alternative of not participating in the research). The participant 
has had an opportunity to ask questions and in my opinion is capable of freely consenting to participate 
in this research. 
 
 
 
Name: ______________________   (print) 
 
 
 
Signed: 
 
_____________ Person Designated to Obtain Consent 
 
 
 
 
Date:________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
                                                          08/26/2020 
 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
1
        
 
 
Consent Summary Page 
  
• 
Overview 
Below is a summary of the study that you are asked to participate in. This outline is meant to be a guide for you to 
use while considering the study and reading the consent form.  It is not meant to replace the consent form, which 
you will have to sign if you decide to participate in the study.  The consent form contains detailed information 
about the study and about the risks which you will need to consider before making your decision.  Read the 
consent form carefully and discuss it with others before deciding to take part.  And remember that, even if you 
agree to participate,  you can change your mind at any time.  
The purpose of the study is to compare two forms of therapy for depression Cognitive Behavior Therapy (CBT) 
and Nonspecific supportive treatment, and examine whether their effectiveness relates to concepts about self and 
others. In each therapy you will receive 12 individual sessions. You will not be able to choose which therapy you 
will receive but both are considered effective for treating depression. Precautionary measures will be taken to 
prevent the transmission of COVID-19 in experimental processes. Most of your visits will be conducted remotely 
using the telephone or HIPAA-compliant video teleconferencing. 
 
• 
Voluntary 
As with all research, this is a voluntary study, and you do not have to participate if you do not want to.  Also, you 
may stop participating at any time. 
 
• 
Alternative Treatments/Alternatives to Participation 
Medications, interpersonal psychotherapy (IPT), dialectic behavior therapy (DBT), group therapy. 
 
• 
Procedures 
1. Evaluation for Major Depression Disorder (remote session). 
2. Self-report study measures (beginning, midpoint, end) done online. 
3. EEG and cognitive tests (beginning and end) done in the lab at NYSPI. 
4. 12 weekly sessions of Cognitive Behavior Therapy for Depression or 12 weekly sessions of Supportive 
Therapy for Depression(remote sessions). 
5. Participants cannot be on psychotropic medications during the study. Medicating for depression will not be 
part of this study.  
6. Participants will be interviewed about symptoms of depression every 3 weeks, and will fill a self-report 
measure on their symptoms every week (remote sessions, and measures done online). 
 
• 
Risks and Inconveniences 
This study includes some risks and discomforts (please refer to the consent form for further details and 
explanations of these risks).  These include no change of your depressive symptoms. Sometimes psychotherapy 
might increase sadness and anxiety.  
You should exercise caution when traveling in public and follow public health guidelines, such as wearing masks 
in public and avoiding crowds. It is important for you to stay informed about public health recommendations and 
guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local 
government guidelines and directives. If you have questions about how you will travel for appointments, or do not 
feel safe traveling, please let us know, and be advised that you can call to reschedule visits 
 
• 
Benefits 
Although some benefit is possible such as reduction of depressive symptoms, you may not have any benefit if the 
treatment is not effective.  
 
• 
Questions 
You may contact the study principal investigator, Ronit Kishon, at 646 724 4171 with any question 
 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
2
 
 
 
 
CONSENT FORM Study # 6806R 
Cognitive Behavior Therapy for Depression 
 
 
Purpose and Overview 
The purpose of the study is to compare two forms of therapy for depression since we still can’t predict 
which one will be more helpful for a particular person. Previous studies suggested that Cognitive 
Behavior Therapy (CBT) is an effective treatment for depression in nearly half of the individuals who 
do it, however there are others who do not benefit from it. Nonspecific supportive treatment focuses 
on meeting with a therapist, receiving support, having one's hope restored, and overcoming 
demoralization. In each of the treatments you will receive12 virtual sessions. You will be randomly 
assigned to one or the other. The purpose of this study is to explore whether your concepts about 
yourself and others are related to the effectiveness of each of the treatments. Also, you must enroll in 
Dr. Kayser's study (#6559) for the purpose of behavioral and electrophysiological tests at two time 
points that will contribute to our study. The aim is to learn more about brain function in people who 
are depressed and receive different types of talk therapy. 
 
 
Voluntary 
Participation in this research study is voluntary. If you decide not to participate, or if you later decide 
to stop participating, you will not lose any benefits to which you are otherwise entitled. A decision not 
to participate or withdraw your participation will not affect your current or future treatment at the New 
York State Psychiatric Institute or Columbia University Medical Center. If you are determined to be 
eligible for the study and later stop your participation for any reason, the study principal investigator, 
Dr. Kishon will treat you until the appropriate referral will be in place. You will be notified of significant 
new findings that may relate to your willingness to continue to participate in the study. 
 
 
Alternative Treatments/ Alternatives to Participation 
You do not have to participate in this study to receive treatment for your depression. CBT and 
nonspecific supportive therapy can be obtained outside of study participation. There are medications 
that have been shown to be effective for depression and can be prescribed by your regular physician. 
There are also other non-medication treatments for depression beside CBT such as interpersonal 
psychotherapy, or group therapy. 
 
 
Procedures 
Precautionary measures will be taken to prevent the transmission of COVID-19 in experimental 
processes. All  your visits in this protocol will be conducted remotely using the telephone or HIPAA-
compliant video teleconferencing. In this study most of the evaluation process and all psychotherapy 
sessions will be done virtually. We will discuss with you the technology HIPAA-compliant platforms to 
be used and any concerns you may have, such as access to a private space in which to take calls, or 
accessibility—access at home to adequate devices, cell signal, or Wi-Fi. In the CBT treatment, you will 
receive 12 weekly remote psychotherapy sessions that last about 50 minutes each. The treatment 
involves being asked questions about your thoughts and feelings, as well as learning skills to manage 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
3
them. In nonspecific supportive therapy you will also receive 12 sessions that last 50 minutes each.  
In the sessions you will receive support and understanding for your problems, so to have your hope  
restored and to overcome demoralization. 
 
Study measures:  
You will be interviewed remotely and you will fill some self-report measures online  for a total of an hour 
and 15 minutes before treatment, in week 6, and after 12 weeks when the treatment is completed. We 
will also ask you before each session to fill a self-report measure that takes 5 minutes so we can 
monitor your symptoms. Every 3 weeks we will interview you for 15 minutes, again with the intention of 
monitoring your level of symptoms. The brain tests will be administered in Dr. Kayser’s study( #6559).  
 
Medications during the study:  
You can participate in the study if you did not take prescribed antidepressant, or over the counter 
antidepressant medications, in the past month (three months for fluoxetine). You will be able to 
continue receiving psychotherapy sessions in the study if your clinical condition will initiate your outside 
physician to prescribe psychotropic medications. 
 
The study doctors will end your study participation if they determine it is no longer in your best interest. 
In addition, you may stop participating in this study at any time for any reason. If you stop participating 
in the study before 12 weeks end, the study principal investigator, Dr. Kishon, will continue to see you  
for sessions until an appropriate referral will be made. Completion of the study is not required for you to  
receive these sessions by Dr. Kishon. 
 
Cognitive Behavior Therapy and Nonspecific Supportive Therapy – Audiotaping: 
You  will be audiotaped during your treatment visits. The audiotaping is optional. The audio recording 
will be used for education, research or training purposes only. Any audio recording will not include your 
full name, and will be reviewed by Dr. Kishon who will evaluate the treatment provided by therapists in 
this study. The audio recordings are kept for no more than 10 years after which they will be destroyed. 
If you withdraw your consent, audio recordings can be destroyed during or after the interview or 
procedure. 
 
Treatment After the End of the Study:  
After the study is over, the Principal Investigator, Dr. Kishon, will meet with you, and answer any 
questions you may have. If after completion of the study you have not improved, you will receive 
referrals for continuation of psychotherapy and/or medications. You will be able to see Dr. Kishon for 
weekly sessions until the referral is in place.  
 
Investigator Initiated Discontinuation of Study:  
There may be times when the investigator carrying out this study decides to stop the study even 
though you may wish to continue to participate. Examples include missing 4 number of sessions or not 
responding to repeated attempts to contact you. 
 
Risks and Inconveniences 
The primary risk of participating in this study is that the treatment may not help your symptoms. If you 
do not improve it may be up to 12 weeks from the time you enter the study until you would be provided 
with another type of treatment. Therefore, if you do not improve, participating in this study will delay your  
receiving treatment for up to 12 weeks with medications and other psychotherapies known to be helpful. 
The risks of psychotherapy treatment include the possibility of increased anxiety or sadness, and the 
therapists will try to help you with that if it occurs. We anticipate that the risks of study participation are 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
4
no greater than those encountered in routine clinical treatment. However, you may be withdrawn from 
the study and offered other treatment. 
 
Benefits: 
A direct benefit to you is the possibility that the treatments will help your symptoms of depression. In 
addition, your participation may help researchers learn more about how to treat depression. There may 
be no benefit to you if the treatment is not effective. 
 
The knowledge gained from this study may contribute to a better understanding of psychiatric disorders,  
and it may contribute to the development of objective measures for diagnosis and treatment selection. 
 
Confidentiality 
All records will be stored in locked files and will be kept confidential to the extent permitted by law. 
Records will be available to research staff, and to Federal, State and Institutional regulatory personnel 
(who may review records as part of routine audits). 
 
Your name and other personal identifying information will be stored in an electronically secure database 
at New York State Psychiatric Institute. Research data that is entered into the computer will be stored 
according to study ID. A master list linking the patient name to the assigned ID is kept in a separate file.  
In order to access, the computer and appropriate data files, the staff member must know have 
knowledge of the password and be given rights to access the data by the data manager. 
All data that is transmitted via computer is encoded and identifying information is removed. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
Your private information could be used for future research studies or distributed to 
another investigator for future research studies, with or without identifiers. Should any of the information 
gathered from you be used for scientific publications or presentations, you will be protected through the 
use of a system of codes that will not reveal the identity of individuals. Any report based on this study 
will only be used as grouped information without mention or description of the individual participants. 
 
The NYSPI Remote Communications Guidance will be followed to ensure protection of 
confidentiality. This discussion and documentation of consent is carried out in a HIPAA – compliant 
teleconference as well as the psychotherapy sessions. Instruments to be completed  
will be completed via REDCap, a HIPAAA-compliant platform to ensure confidentiality. Our research 
assistants will assist you in using those platforms.  
 
In case of Injury 
Federal regulations require that we inform participants about our institution's policy with regard to 
compensation and payment for treatment of research-related injuries. If you believe that you have 
sustained an injury as a result of participating in a research study, you may contact the Principal 
Investigator Dr. Ronit Kishon at 646-724-4171 so that you can review the matter and identify the 
medical resources that may be available to you. 
 
In case of injury, New York State Psychiatric Institute will provide short-term emergency medical 
treatment, which has been determined to be necessary by New York State Psychiatric Institute's 
doctors, and which is within the capability of New York State Psychiatric Institute to provide. In addition, 
we will provide assistance in arranging follow up care in such instances. 

 
 
 
                                                                                                                                                       08/20/2021 
                                                                                                                                                                                  
5
 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not provide 
compensation or payment for treatment of research related injuries. However, you should be aware that 
you do not give up your legal right to seek such compensation through the court by participating in this 
research. 
 
 
Questions 
Dr. Kishon will answer to the best of her ability any questions that the participant may have now or in the 
future about the research procedures, or about the subject's response to the procedures. She can be  
 
reached during the day, and outside of regular business hours at 646-724-4171. Dr. Kishon can be 
called outside of regular business hours for important issues that should not wait until the next business 
day. In the case of an EMERGENCY go to your nearest emergency room and call Dr. 
Kishon. 
 
If you have any questions about your rights as a research participant, want to provide feedback, or have  
a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a committee that 
protects the rights of participants in research studies). You may call the IRB Main Office at (646)774-
7155 during regular office hours. 
 
You will be given a copy of the signed Consent Form.

 
                                                          08/26/2020 
                                                                                                                                                                                 
 
 
Documentation of Consent 
 
I voluntarily agree to participate in the research study described above.  
 
 
 
Name:___________________________  (print) 
 
Signed __________________________    Study Participant 
 
Date: __________________________ 
 
 
I have discussed the proposed research with this participant including the risks, 
benefits, and alternatives to participation (including the alternative of not participating in 
the research). The participant has had an opportunity to ask questions and in my 
opinion is capable of freely consenting to participate in this research. 
 
 
 
Name: ______________________   (print) 
 
 
 
 
 
 
 
 
Signed: 
 
_____________ Person Designated to Obtain Consent 
 
 
 
 
Date:___________  
 

Form #PP2: HIPAA Authorization for Research 4.14.14 
New York State Psychiatric Institute (NYSPI) 
Authorization to Use or Disclose Health Information during a Research Study 
Protocol Number: 
Principal Investigator: 
Name of Study: 
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about you as described below: 
•
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
•
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
•
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;EKI), iĨ indicated in the consent form.
1.
The Health Information that may be used andͬŽƌ disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.   
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research. 
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and  
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health
#6806
Ronit Kishon Ph.D. 
Cognitive Behavior Therapy for Depression 
Nathan Kline Institute (where laboratory specimens are analyzed)

Form #PP2: HIPAA Authorization for Research 4.1.14 
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
•
You do not have to sign this Authorization form, but if you do not, you may not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
•
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of Participant/ Legal Representative    
Date 
______________________________________ 
Printed Name of Participant 
______________________________________ 
Relationship of Legal Representative to Participant (if applicable) 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 
Ronit Kishon Ph.D.
1051 Riverside Drive
New York NY 10032
Ronit Kishon Ph.D.
1051 Riverside Drive
New York, NY 10032