Attention-Bias Modification Treatment for PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Sponsor: Research Foundation for Mental Hygiene, Inc.

Cover Page for ClinicalTrials.gov 
Official Title of the Study: 
 
Attention-Bias Modification Treatment for PTSD 
NCT Number: 
 
NCT01888653. 
Principal Investigator:  
 
Yuval Neria, PhD 
 
Yuval.Neria@nyspi.columbia.edu 
 
646-774-8041 
Date of Document: 
 
March 5, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Signed copy on file at IRB 
 
             v. 11/15/13 
New York State Psychiatric Institute 
Institutional Review Board 
 
March 5, 2019 
 
 
To: 
 
Dr. Yuval Neria 
From:  
Dr. Edward Nunes, Co-Chair 
 
 
Dr. Agnes Whitaker, Co-Chair 
 
 
 
 
 
 
Subject: 
Approval Notice: Continuation Expedited per 45CFR46.110(b)(1)(f)Category 8(c) 
 
 
 
 
 
Your protocol #6688 entitled:  NEURAL AND BEHAVIORAL MARKERS OF ATTENTION-BIAS 
MODIFICATION TREATMENT IN PTSD  Protocol version date 03/05/2019 has been approved by the 
New York State Psychiatric Institute - Columbia University Department of Psychiatry Institutional 
Review Board from April 1, 2019 to March 31, 2020.  
 
Consent requirements: 
      √  Not applicable: Data Analysis Only 
    45CFR46.116 (d) waiver of consent for secondary data analysis 
       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.    
 
 
 
 
 
 
EN/AW/kpz4alw 

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Protocol Title:
Neural and Behavioral Markers of 
Attention-Bias Modification Treatment in 
PTSD
Protocol Number:
6688
First Approval:
05/09/2013
Expiration Date:
03/31/2020
Version Date:
03/05/2019
Clinic:
Anxiety Disorders Clinic
Contact Principal Investigator:
Yuval Neria, PHD
Email: ny126@columbia.edu
Telephone: 646-774-8092
Co-Investigator(s):
John Markowitz, MD
Franklin Schneier, MD
Erel Shvil, PHD
Research Chief:
Helen Simpson, 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 
Division & Personnel
Division
What Division/Department does the PI belong to?
Dept of of Psychiatry, Theraputic Div
Within the division/department, what Center or group are you affiliated with, if any? 
Anxiety Disorders Clinic 
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 

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State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
 
 
 
Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis 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.
To date we have enrolled 51 subjects with Posttraumatic Stress Disorder (31 female, 20 male). Study 
procedures have been well tolerated. There have not been any study findings, recent literature, or untoward 
events occurring here or at other sites in the past year which might affect the analysis of the safety, risks, or 
benefits of the study. 
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

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Is the study covered by a certificate of confidentiality? 
No
Overall Progress
Approved sample size
60
Total number of participants enrolled to date
51
Number of participants who have completed the study to date 
41
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
PTSD
Total number of participants enrolled from this population to date 
51
Gender, Racial and Ethnic Breakdown 
39% Male
61% Female
 
Racial and Ethnic Breakdown:
44% White
34% African American
10% Asian/Pacific Islander
12% Other
 
78% Hispanic
22% Non-Hispanic 
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
0
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 

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No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Psychiatric Assessment
   Use of Placebo or Sham Treatment
   Psychotherapy Trial
Population
Indicate which of the following populations will be included in this research
   Adults
   Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
Yes
Describe internal account
The study is funded by a gift account that is administered through RFMH.
Is the project externally funded or is external funding planned?
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
The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, 
and risk/benefit ratio of ABMT in individuals with PTSD. This pilot study also seeks to identify specific 

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genes associated with anxiety disorders and to examine whether these can predict the success of the ABMT.  
In addition, pilot data assessing pattern separation (refers to the ability to encode inputs with some degree of 
overlapping information into distinctive representations) will be collected in subjects with PTSD via a brief 
memory task, named the Behavioral Pattern Separation Task—Object Version (BPS-O) (see Study 
Procedures section (4.A.8.) for a full description of the task). 
Research Design: This pilot study aims: (1) to examine feasibility and acceptability of attention-bias-
modification treatment (ABMT) in PTSD. The sample will include individuals with PTSD (n=60) with 
attention bias towards and/or away from threat (documented by dot probe task), which will undergo a 4-
week (8-sessions) course of ABMT or an inactive Comparison Training Program (CTP).
 Methods: The sample (n=60) will be randomized equally into two groups: Group 1 will receive a 4-week 
(8-sessions) course of inactive CTP; and group 2 will receive a 4-week (8-sessions) course of ABMT. The 
randomization will be stratified by age [<40 vs. 40] and gender [M/F]. All subjects will repeat the Dot- 
Probe Task after the four weeks of treatment to reassess attention bias. 
 
 
 
 
Background, Significance and Rationale
Background, Significance and Rationale
Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders1-4. 
Recent findings demonstrate significant associations between attention bias and stress vulnerability5, 6. This 
work has motivated the development of a novel therapy, attention-bias-modification treatment (ABMT). 
ABMT is designed to implicitly modify patients' biased threat attendance via computerized training 
protocols. Emerging evidence indicates that ABMT is effective in modifying threat-related attention biases 
and in ameliorating anxiety symptoms7,8,9,10. However, it is unclear whether ABMT is efficacious for 
Posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine 
feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABMT in individuals with PTSD. In 
addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine 
whether these can predict the success of the ABMT. In addition, pilot data assessing pattern separation 
(refers to the ability to encode inputs with some degree of overlapping information into distinctive 
representations) will be collected in subjects with PTSD via a brief memory task, named the Behavioral 
Pattern Separation Task—Object Version (BPS-O) (see Study Procedures section (4.A.8.) for a full 
description of the task). Evidence suggests that impaired pattern separation, which is a deficiency in the 
ability to differentiate similar stimuli, underlies fear overgeneralization and may be highly associated with 

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attention bias to threat commonly seen in different anxiety disorders. Thus, we ask to collect pilot data 
assessing pattern separation for a potential grant that will assessed the putative association between – 
attention bias, impaired pattern separation and fear overgeneralization in PTSD.
 
 
 
 
Specific Aims and Hypotheses
Specific Aims and Hypotheses
This pilot study aims to examine feasibility and acceptability of attention-bias-modification treatment 
(ABMT) in PTSD. 
Hypothesis 1: (1) ABMT will diminish attention bias at post-treatment assessment (Dot-Probe) compared to 
CTP. (2) ABMT will produce greater symptomatic response (defined as >30% reduction on CAPS) than the 
CTP.
 
Description of Subject Population
Sample #1
Specify subject population
patients with DSM-IV Diagnosis of PTSD
Number of completers required to accomplish study aims
50
Projected number of subjects who will be enrolled to obtain required number of completers
60
Age range of subject population

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18-60
Gender, Racial and Ethnic Breakdown
Population Sex:  
Females  - ~60%
Males -  40%
 
Population Ethnicity:
 African-American- 30%
 Hispanic- 15%
 Caucasian- 45%
Asian/Pacific Islander - 10%
 
 
Description of subject population
We expect greater proportion of females than males  due to the higher prevalence of PTSD among women 
in the US population. The ethnic distribution, represents the typical ethnic breakdown of the anxiety 
disorders clinic population, moderated by the ethnic breakdown of the current subject population.
 
 
Recruitment Procedures
Describe settings where recruitment will occur
Anxiety Disorders Clinic 
 
 
How and by whom will subjects be approached and/or recruited? 
Patients will respond to an advertisement (see below "study advertised/ publicized"). Patient will call the clinic and after verbal 
consent the research assistant (RA) will conduct a preliminary screening. If the patient will be eligible for the study the RA will invite 
him for further screening at the clinic.
How will the study be advertised/publicized? 

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Patients will be informed of the study through: (a) word-of-mouth referrals from former patients, (b) referral 
from area medical and mental health professionals, (c) publicity about the study, including articles in local 
newspapers and magazines, our IRB approved website (www.columbiatrauma.org), IRB approved flyers, 
appearances on local radio and television shows, etc., leading to self-referral of prospective patients, and (d) 
advertisements placed in local media and on the Internet (e) recruitme 
 
Do you have ads/recruitment material requiring review at this time? 
No
Does this study involve a clinical trial?
No
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
No
Inclusion/Exclusion Criteria
Name the subject group/sub sample
PTSD
Create or insert table to describe the inclusion criteria and methods to ascertain them
Inclusion criteria:
Method of Ascertainment:
1. Males or females between the ages of 18 and 60.
 History
2. Current DSM-IV PTSD 
SCID
3. Score equal or greater than 50 on the CAPS.          
CAPS administration
 
4. Fluent in English and willing and able to give informed written 
consent and participate responsibly in the protocol.
Clinical interview
5. threat bias (i.e., >8ms mean decrease or increase in reaction 
time to threat faces vs. neutral faces on dot-probe task) at 
baseline. 
Dot-probe attention bias task 
administration
Create or insert table to describe the exclusion criteria and methods to ascertain them
Exclusion criteria:
Method of Ascertainment:
1. Current DSM-IV Axis I disorder other than 
SCID, HAM-D and clinical evaluation

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PTSD.  Patients with comorbid (i.e., secondary 
diagnosis of) major depressive disorder (MDD) will be 
allowed for enrollment if their HAM-D score doesn’t 
exceed 25. 
2. Prior or current diagnosis of schizophrenia, 
schizoaffective disorder, organic mental disorder, 
bipolar disorder, or antisocial, schizotypal, and 
schizoid personality disorders.
SCID and clinical evaluation
 
 
 
 
3.Suicidal ideation or behavior that poses a 
significant danger to the subject. Unstable clinical 
condition such that participation in a controlled 
trial would pose a significant danger.
 
Psychiatric history; score > 2 on item 3 of the 
Hamilton Rating Scale for Depression (HRSD-21-
item), and the BDI suicide item
4. Prior participation in attention bias 
modification treatment (ABMT).
Psychiatric interview 
5. Current or past history of seizure disorder 
(except febrile seizure in childhood).
Clinical evaluation
 
6. Currently on psychotropic medication. 
(excluding the use of hypnotics)
 
Clinical Interview regarding current medication 
treatment history.
7.  Currently participating in formal 
psychotherapy. This includes: psychodynamic, 
cognitive behavioral and interpersonal therapies.
 
 History   
8.   Current unstable or untreated medical illness. 
Clinical interview, Medical history
10. Vision loss.
Preliminary screening, Clinical evaluation
 
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

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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?
No
Describe procedures used to obtain consent during the screening process 
Potential subjects will be screened by telephone by a research assistant after obtaining oral consent (IRB# 
7094R, previously IRB # 6112R).
Psychiatric Diagnostic Evaluation: Patients deemed study eligible following preliminary screening will sign 
the Anxiety Disorders Clinic informed written consent for the psychiatric screening evaluation (IRB# 
7094R, previously IRB # 6112R). An experienced psychiatrist will evaluate presenting symptoms, 
psychiatric history, treatment history, medical history, trauma history, social and family history, and current 
medical status. A Clinician-Administered PTSD scale (CAPS), Hamilton Depression Scale (HAM-D) as 
well as the Attention bias testing (Dot-Probe Task) to determine further eligibility for the study.
If the subject is eligible and if s/he consents for it, s/he will give DNA sample via saliva (~2 cc total) and 
will fill out the Ancestry Questionnaire. This questionnaire is very short and asks participant’s to provide 
details of the country of birth and ancestry of their four grandparents. If the subject is not eligible, 
participation in the study will end and they will be referred to other studies or given the appropriate 
referrals. Subjects who are not eligible will not be asked to provide a saliva sample. 
 
Describe Study Consent Procedures
Patient will meet face to face with the person that authorizes to discuss and document consent (see "person 
designed to discuss and document consent"). After patient reads the consent the clinician will go over the 
consent with the patient and answer all the patient's questions. After answering all the patient's questions by 
the clinician patient will sign the study consent. Throughout this process, the patient's will be told that they 
are free to refuse and that participation or non- participation in research has no effect on their ability to 
continue to receive clinical care or services. 
 
 
Indicate which of the following are employed as a part of screening or main study consent procedures

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   Consent Form
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Lazarov, Amit
Lowell, Ari
Neria, Yuval, PHD
Suarez-Jimenez, Benjamin
Type in the name(s) not found in the above list
Study Procedures
Describe the procedures required for this study
The study consists of the following procedures:
1) eligibility and baseline assessment
2) treatment visits (ABMT or CTP)
3) post treatment assessment for both ABMT and CTP group
Preliminary Screening: Potential subjects will be screened by telephone by a research assistant after 
obtaining oral consent. Psychiatric Diagnostic Evaluation: Patients deemed study eligible following 
preliminary screening will sign the Anxiety Disorders Clinic informed written consent for the psychiatric 
screening evaluation (IRB # 6112R). An experienced psychiatrist will evaluate presenting symptoms, 
psychiatric history, treatment history, medical history, trauma history, social and family history, and current 
medical status. A Clinician-Administered PTSD scale (CAPS), Hamilton Depression Scale (HAM-D) as 
well as the Attention bias testing (Dot-Probe Task) to determine further eligibility for the study.
If the subject is eligible and if s/he consents for it, s/he will give DNA sample via saliva (~2 cc total) and 
will fill out the Ancestry Questionnaire. This questionnaire is very short and asks participant’s to provide 
details of the country of birth and ancestry of their four grandparents. If the subject is not eligible, 
participation in the study will end and they will be referred to other studies or given the appropriate 
referrals. Subjects who are not eligible will not ask to provide a saliva sample. 
Selection of Participants Based on the Existence of Baseline Threat Bias: To ensure attentional bias in 
participants enrolled in the study, before they begin treatment and after they have signed study consent, their 
threat related attentional bias will be assessed through a simple computerized task. If they do not have 
attentional bias towards or away from threat at baseline, their participation in the study will end and they 
will be referred to other studies or given the appropriate referrals. The basic target for ABMT is pre-existing 
(pre-treatment) threat bias; hence the absence of such bias (not uncommon amongst anxious patients) might 
render ABMT ineffective11.

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Assessment of Attention Bias: the Dot-Probe Task: The dot-probe task version will be used for the 
attention bias assessment at baseline to establish eligibility at treatment, and on post-treatment assessment. 
A trained research assistant will administer these tasks.
The stimuli for the dot-probe task will be derived from pairs of face stimuli with angry and neutral 
expressions used by Bar-Haim and colleagues13. Two sets of faces will be used in the study (set A and set 
B). One set will be used for assessment and the other set will be used for training, allowing us to infer 
generalization. The faces-based dot-probe task will follow the protocol of the TAU-NIMH ABMT Initiative 
(Drs. Pine and Bar-Haim: PIs). The face stimuli are photographs of 20 different individuals (10 female) 
taken from the NimStim stimulus set, except for one female taken from the Matsumoto and Ekman set. 
Images of individuals will be randomly divided into two sets (A and B) – set A will be used for all subjects 
in the present study. The face display consists of pairs of angry-neutral or neutral-neutral faces of the same 
individual. The pre- and post-ABM/Comparison measurement protocol consists of 120 trials (80 angry-
neutral and 40 neutral-neutral presentations). For both word-based and faces-based tasks, the target-probe 
display consists of an arrowhead pointing either left or right (“<” or “>”). The target appears at the location 
previously occupied by one of the stimuli, with a small, random jitter around the center of the stimuli. In 
each trial the participant is presented with the fixation cross (500ms), followed by the stimulus pair display 
(500ms), followed by the target display (1000ms). Response is followed by an inter-trial interval (average 
500ms). In addition, fixation trials are included to be able to deconvolve the hemodynamic response 
function. Across trials, angry-face location, probe location, probe type, and actor are fully counterbalanced 
in presentation. If the subject performs with less than 70% accuracy on the first 10 trials, the program will 
display a warning and the experiment will be aborted. This warning provides an opportunity to re-brief the 
subject and initiate data collection again.
DNA Collection, Extraction and Analysis: The protocol to be used for collecting DNA samples will be 
identical to that which was previously used by Dr. Thalia Eley, Institute of Psychiatry, London, and Dr. Yair 
Bar-Haim, Tel-Aviv University, Israel. After the Eligibility assessment and consent, a saliva sample (~2 cc 
total) will be collected from each subject to be used for analyses of genomic DNA. Deindentified samples 
will be sent via secure air courier and with the appropriate documentation to Institute of Psychiatry (IoP) at 
King’s College London for extraction of DNA using well-established protocols. After extraction, the 
original sample is destroyed and the extracted DNA is stored securely in IoP’s laboratory system using a 
unique alpha-numeric code only. IoP will then genotype the samples with the aim of identifying genetic 
markers for ABMT efficacy. The primary candidate marker is the serotonin transporter polymorphism 
(5HTTLPR), which has been linked to performance on the dot-probe task and also treatment response. The 
lab will also investigate a limited number of other candidate markers based on the current understanding of 
the mechanisms involved in etiology and treatment response.
Treatment. Method of Assuring Double Blindness (ABMT and CTP): Participants will be randomly 
assigned to one of two conditions: ABMT or CTP. A research coordinator will place the randomly assigned 

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condition number in an envelope in each participant's file at the beginning of the study. Prior to each 
training session, another experimenter blind to the studies' aims and protocols will enter the number in the 
file into the computer to automatically begin the appropriate program. Participants will not know which 
condition the number represents. Thus, participants and experimenters will remain blind to the participant’s 
condition until all post-ABMT or post-CTP assessments are conducted. To assess whether participants 
remained blind to their respective experimental condition, we will ask them at post-assessment whether they 
thought they had received the active versus comparison intervention. A trained research assistant will 
administer the computer-based ABMT and CTP sessions.
Attention-Bias Modification Treatment (ABMT): During each session, 240 trials (80 neutral-neutral 
pairs, 160 threat-neutral pairs) will be presented.  On trials where participants see one neutral face and one 
angry face the probe will always follow the neutral face location. Thus, although there is no specific 
instruction to direct attention away from angry faces, on 66% of all trials (and 100% of the threat-neutral 
trials) the position of the neutral faces will indicate the position of the target probe.
Comparison-Training-Program (CTP): The comparison condition is identical to the ABMT protocol 
except that during the presentation of the trials where a angry face is presented, the probe will appear with 
equal frequency in the position of the threat and neutral face. Thus, neither threat nor neutral faces provide 
information regarding the position of the target probe, and there is no contingency between the position of 
either threat or neutral faces and the position of the probes.
Behavioral Pattern Separation-Task Object Version (BPS-O): The BPS-O is a well-established and 
reliable task19 that was developed in order to characterize the behavioral outcomes of neural pattern 
separation. The task consists of two phases; a study phase and a test phase. In the study phase, participants 
engage in an indoor/outdoor judgment of pictures of everyday objects. In the test phase, immediately 
following the study phase, participants are given instructions regarding a surprise recognition memory test 
in which they have to identify each item as either “old”, “similar”, or “new”. One-third of the images in the 
test phase are exact repetitions of images presented in the study phase (targets); one-third of the images are 
new images not previously seen (foils); and one-third of the images are perceptually similar to those seen 
during the study phase, but not identical (lures).  We are particularly interested in the responses to these lure 
trials and the rates at which participants correctly identify these as “similar”, avoiding the propensity to 
identify these as “old”. Identifying these lure trials as “old” (i.e., over generalization) is likely driven by 
impaired pattern separation processes. The task takes 20 minutes.
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
The PI and study psychiatrist will review at least weekly all currently enrolled patients in the ABMT and 
CTP treatment, and will withdraw a person from the study if the participant:

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1.   Requests to be withdrawn from the study.
2.   A single CGI-I score of 6 or more will trigger evaluation of a participant whose condition 
seems to be worsening, and prompt an immediate visit within the next few days. The CGI will 
be administered to consider PTSD, and depression symptomatology.
3.   Reports significant suicidal ideation, as assessed by the clinician and/or by the BDI-II- suicide 
item. 
4.   Shows clear-cut deterioration in social or occupational functioning. 
5.   Is non-compliant with protocol requirements. 
6.   Manifests a new or inter-current illness that prevents the patient from complying with the 
protocol.
Withdrawal from this protocol prior to the second Dot-Probe assessment will not affect the 
treatment to which all patients enrolling in the study are entitled.
 
 
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
SCID (90 minutes at screening)
Beck Depression Inventory (10 minutes)
Clinical Global Impression – Severity Scale (CGI-S) (5 minutes)
Clinician Administered PTSD Scale (CAPS) (30 Minutes)
Hamilton Rating Scale for Depression (Ham-D) (10 minutes) 
Spielberger State-Trait Anxiety Inventory (5 minutes)
The Life Events Checklist (LEC) (5 minutes)
The Dot-Probe- Tasks (10 minutes for both tasks)
                        Ancestry Questionnaire (5 minutes)
Behavioral Pattern Separation-Task Object Version (BPS-O) (20 minutes)  
Please attach copies, unless standard instruments are used

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Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
The maximum delay in provision of treatment will be 2 weeks for participants randomized to ABMT, and 6 
weeks for participants randomized to CTP. The study treatment, ABMT, has appeared effective for some 
anxiety disorders, but is not an established treatment for PTSD.
 
 
Maximum duration of delay to standard care or treatment of known efficacy
The maximum delay in provision of active treatment will be 6 weeks (2 weeks for baseline assessments and 
4 weeks for study treatments) from initial in-person psychiatric intake evaluation. 
 
Treatment to be provided at the end of the study
Patients will be offered 3 months of medication and/or psychotherapy treatment in the ADC until they are 
remitted or referred to treatment elsewhere.  
Clinical Treatment Alternatives
Clinical treatment alternatives
Patients will be offered 3 months of medication and/or psychotherapy treatment in the ADC until they 
are remitted or referred to treatment elsewhere.  
 
 
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period

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Interviews/assessments: Some subjects may find the interviews and assessments to be anxiety provoking 
or upsetting. Subjects will be informed that they may choose not to answer specific questions, and may stop 
the interview at any time if they are feeling uncomfortable. Every effort will be made to ensure patients’ 
comfort. 
Risks Associated with Treatment Procedures: To date, there are no known risks associated with 
ABMT. The procedures involve repeated exposures to photographs of faces.  As the procedures involved in 
these tasks are similar to those encountered in daily life, no adverse events are anticipated. Participants may 
become fatigued when completing the computer sessions. Breaks will be offered frequently. Every effort 
will be made to ensure patients’ comfort during treatment, and patients will be withdrawn if needed.  Non 
improvement and/or worsening: There is the risk that some patients will not improve clinically or will 
experience worsening of their symptoms during the course of the treatment. A single CGI-I score of 6 or 
more will trigger evaluation of a participant, and prompt an immediate visit within the next few days. 
Patients who receive two consecutive CGI improvement ratings of 6 or 7 will be removed from the study 
and begin open treatment.
 
Saliva-sample: The main risk is that participants might find it uncomfortable to not eat or drink for 
an hour prior to giving the sample. Participant that will choose not to participate will not loss any of the 
benefit to which he is otherwise entitled. 
 
Behavioral Pattern Separation-Task Object Version (BPS-O): there is no known risk that is associated 
with this task.
 
Describe procedures for minimizing risks
a. Careful medical and psychiatric screening will be used to identify subjects whose risk for potential 
adverse effects from treatment is elevated. Such subjects will be excluded from the study. For example, an 
actively suicidal patient would be excluded from study participation in order to provide immediate and 
appropriate clinical treatment. 
b. Assessment of safety during first 4 weeks: All patients will have a clinical safety assessment completed 
by the study clinician during baseline and every week after that, including Clinician-rated CGI change scale 
and inquiry as to whether the participant is experiencing any worsening social anxiety, depression or other 
symptoms, or any suicidal ideation. (Patients answering affirmatively to any of these queries will be further 
evaluated for the safety of continuation in the study, including completion of QIDS-C. Significant 
worsening on the clinician-rated CGI change scale (score of 6 or more) or clinically significant suicidal 
ideation score > 2 on item 12 of (QIDS-C) are two examples of conditions that would require termination of 
study treatment and will prompt an immediate visit within the next few days. 
c. Patients will be instructed to contact study personnel at any point in the study in the event of worsening of 
symptoms or relapse. Patients deemed to have clinically significant deterioration, relapse, who develop 
other symptoms such as suicidal ideation that interfere with safe participation, or who ask to discontinue 
research participation will be removed from the study and given appropriate clinical care.

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d. At the end of the treatment, all patients will be provided with appropriate standard clinical care. The exact 
nature of “appropriate standard clinical care” will be determined by the judgment of clinicians familiar with 
the specific patient and may include medication, CBT treatment, or other modalities. 
e. As in any type of treatment or clinical research program, patients' confidentiality will be carefully guarded 
and respected. All data with identifying information will be stored in locked file cabinets or password-
protected computer files. Data being analyzed will be identified by subject codes and identifying 
information will be removed. The identity of patients will not be revealed in the presentation or publication 
of any results from the project. All assistants and others working on the project will be educated about the 
importance of strictly respecting patients' rights to confidentiality and will have received training in HIPAA 
and Good Clinical Practices.
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data collected will be kept confidential and used for research purposes only.  Patients’ charts will 
be kept in locked file cabinets identified by number. Access to research records is restricted to 
research staff and Federal, State, and Institutional regulatory authorities. We have obtained  a 
Certificate of Confidentiality from the National Institutes of Health.   Electronic data will be 
protected by password access. 
 
Will the study be conducted under a certificate of confidentiality?
Yes, we have already received a Certificate of Confidentiality
Direct Benefits to Subjects  
Direct Benefits to Subjects
This study is not designed to directly benefit the participants. Participants may or may not benefit from the 
treatment administered in this study
 
 

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Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
All subjects will receive $50 for each of the assessment sessions (pre-treatment and post-treatment 
Dot-Probe task); therefore participants completing both assessments will receive a total of $100. The 
compensation will be mailed to the subject in the form of a check within 4-6 weeks of the 
completion of each assessment.  
 
 
 
 
References
References
1.         Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IMH. Threat-related             
attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull.             
Jan 2007;133(1):1-24. 
2.         Pine DS, Fyer A, Grun J, et al. Methods for developmental studies of fear conditioning circuitry. 
Biological psychiatry. Aug 1 2001;50(3):225-228.
3.        Pine DS, Helfinstein SM, Bar-Haim Y, Nelson E, Fox NA. Challenges in developing novel 
treatments for childhood disorders: lessons from research on anxiety. Neuropsychopharmacology : 
official publication of the American College of Neuropsychopharmacology. Jan 2009;34(1):213-
228.
4.         Shechner T, Britton JC, Perez-Edgar K, et al. Attention biases, anxiety, and development: toward or 
away from threats or rewards? Depression and anxiety. Apr 2012;29(4):282-294.
5.        MacLeod C, Rutherford E, Campbell L, Ebsworthy G, Holker L. Selective attention and emotional 
vulnerability: assessing the causal basis of their association through the experimental manipulation 
of attentional bias. J Abnorm Psychol. Feb 2002;111(1):107-123.

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6.         Eldar S, Ricon T, Bar-Haim Y. Plasticity in attention: implications for stress response in children. 
Behav Res Ther. Apr 2008;46(4):450-461.
7.         Hakamata Y, Lissek S, Bar-Haim Y, et al. Attention bias modification treatment: a meta-analysis 
toward the establishment of novel treatment for anxiety. Biological psychiatry. Dec 1;68(11):982-
990.
8.         Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety 
disorders. Journal of child psychology and psychiatry, and allied disciplines. Aug 2010;51(8):859-
870.
9.       Hakamata Y, Lissek S, Bar-Haim Y, et al. Attention Bias Modification Treatment: A Meta-Analysis 
Toward the Establishment of Novel Treatment for Anxiety. Biological psychiatry. Dec 1 
2010;68(11):982-990.
10.       Bar-Haim Y. Research Review: attention bias modification (ABM): a novel treatment for anxiety 
disorders. Journal of Child Psychology and Psychiatry. Aug 2010;51(8):859-870.
11.       Henkin Y, Feinholz M, Arie M, Bar-Haim Y. P50 suppression in children with selective mutism: a 
preliminary report. J Abnorm Child Psychol. Jan 2010;38(1):43-48.
12.    Eldar S, Apter A, Lotan D, et al. Attention bias modification treatment for pediatric anxiety disorders: 
A randomized controlled trial. American Journal of Psychiatry. Feb 2012;169:213-220.
13.       Bar-Haim Y, Holoshitz Y, Eldar S, et al. Life-Threatening Danger and Suppression of Attention Bias 
to Threat. American Journal of Psychiatry. Jun 2010;167(6):694-698.
14.       Wald I, Lubin G, Holoshitz Y, et al. Battlefield-like stress following simulated combat and 
suppression of attention bias to threat. Psychol Med. Apr;41(4):699-707.
15.       Bar-Haim Y, Morag I, Glickman S. Training anxious children to disengage attention from threat: a 
randomized controlled trial. Journal of child psychology and psychiatry, and allied disciplines. Aug 
2011;52(8):861-869.
16.    Amir N, Beard C, Burns M, Bomyea J. Attention modification program in individuals with 
generalized anxiety disorder. J Abnorm Psychol. Feb 2009;118(1):28-33.
17.    Wald I, Lubin G, Holoshitz Y, et al. Battlefield-like stress following simulated combat and 
suppression of attention bias to threat. Psychol Med. Apr 2011;41(4):699-707.
18.     Shechner T, Pelc T, Pine DS, Fox NA, Bar-Haim Y. Flexible Attention Deployment in Threatening 
Contexts: An Instructed Fear Conditioning Study. Emotion. Mar 5 2012.
19.    Stark, S.M., Yassa, M.A., Lacy, J. W., & Stark, E.L. (2013). A task to assess behavioral pattern 
separation (BPS) in humans: Data from healthy aging and mild cognitive impairment, 
Neuropsychologia, 51, 2442-2449. 

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Uploads
Upload copy(ies) of unbolded Consent Form(s)
Upload copy(ies) of bolded Consent Form(s)
Upload a copy of Certificate of Confidentiality
Upload copy(ies) of the HIPAA form
Upload any additional documents that may be related to this study

Data Analysis 
Independent samples t-tests were used to compare between-groups descriptive 
characteristics at pre-treatment, with a chi-square test for gender distribution. Treatment effects 
were tested using Generalized Estimating Equations (GEE; Zeger and Liang, 1986, Zeger et al., 
1988), as recommended for RCTs (Vens and Ziegler, 2012). GEE accounts for correlated 
repeated-measurements and accommodates missing data under the missing-at-random 
assumption, by computing estimated marginal means, thus serving as an intention-to-treat 
analysis strategy which includes data from all randomized participants who provided at least one 
data point. To represent within-subject dependencies in the models, we specified an unstructured 
covariance matrix. Overall effects of ACT relative to BC-ABM on clinician-rated (CAPS, 
HRSD) and self-reported (PCL-C, BDI-II) PTSD and depression symptoms were estimated using 
models containing main effects of group and time, and their interaction. The time-by-group 
interaction terms reflects the outcomes of interest in an intention-to-treat analysis (Badura-Brack 
et al., 2015) and tests the treatment effect hypothesis of greater improvement (decrease) in 
symptoms over time for one group relative to the other. A Chi-square test was used to compare 
groups on CSC.  
Effects of training on attention indices (AB and ABV) were examined per condition, as 
conditions diverged in training method and goal. Specifically, training-related changes in 
attention bias were examined in the BC-ABM group, while changes in ABV were examined in 
the ACT group.  
All statistical tests were 2-sided, using α≤.05. Effect sizes are reported using Cohen's d 
when appropriate.