- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888653
Attention-Bias Modification Treatment for PTSD
February 15, 2022 updated by: Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders.
Recent findings demonstrate significant associations between attention bias and stress vulnerability.
This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment .
ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols.
Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.
However, it is unclear whether ABM 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 ABM 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 ABM.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols.
Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females between the ages of 18 and 60;
- Current DSM-IV PTSD for the last 12 months or more;
- Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol;
- Attention bias toward or away from threat assessed by Dot-probe attention bias task
Exclusion Criteria:
- Current DSM-IV Axis I disorder other than 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;
- Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders;
- 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;
- Prior participation in attention bias modification treatment (ABMT);
- Current or past history of seizure disorder (except febrile seizure in childhood);
- Currently on psychotropic medication. (excluding the use of hypnotics);
Currently participating in formal psychotherapy. This includes:
- psychodynamic,
- cognitive behavioral and interpersonal therapies
- Current unstable or untreated medical illness;
- Vision loss.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Comparison-Training-Program
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word.
Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
|
In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
Other Names:
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Active Comparator: Attention Biased Modification
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols.
During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented.
On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location.
Thus, although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
|
The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials.
Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa).
In the ABM condition, training was contin- gent on the bias measured at pre-treatment.
Specifically, for those showing a bias toward the threat, the target appeared at the neutral-face location in 100% of the threat-neutral trials, while for those showing a bias away from the threat, the target appeared at the threat-face location in 100% of the threat-neutral trials.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Time Frame: 4 weeks
|
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Time Frame: 4 weeks
|
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuval Neria, PhD, Columbia University and the New York State Psychiatric Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
April 2, 2018
Study Completion (Actual)
April 2, 2018
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Actual)
April 13, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 6688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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