- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242263
ACT With Feedback for Post Traumatic Stress Disorder (PTSD)
Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder
The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).
It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).
The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.
Study Overview
Status
Conditions
Detailed Description
The aim of the current study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).
Individuals with PTSD exhibit increased threat-related attention bias variability (ABV; Lacoviello et al., 2014; Naim et al., 2015). Based on these findings, computerized training methods aimed to modify the attention bias were developed (Attention Bias Modification Training; ABMT).
It seems that the most efficient ABMT method to balance ABV among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).
The purpose of the current study is to examine the efficacy of ACT that also includes a feedback component. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.
For this purpose, we will recruit 60 IDF veterans diagnosed with PTSD that will be randomly assigned to one of two conditions: ACT with feedback or ACT with yoked sham feedback.
We expect that ACT with feedback will produce greater reduction in PTSD symptoms and in ABV relative to ACT with yoked sham feedback.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yair Bar-Haim, Prof.
- Phone Number: +972-3-6405465
- Email: yair1@post.tau.ac.il
Study Contact Backup
- Name: Mai Gelman, MA
- Phone Number: +972-3-6405465
- Email: maigelman@mail.tau.ac.il
Study Locations
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Tel Aviv, Israel, 6997801
- Tel Aviv University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65
Exclusion Criteria:
- Psychotic or Bipolar disorder, drug and alcohol abuse, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training group - ACT with feedback
At the beginning of each session participants will complete 45 standard dot-probe trials.
During these trials, participants' ABV will be measured and set as their baseline.
In the following trials, participants will receive feedback: a green screen background when their ABV will reach below their baseline or a red screen background when their baseline ABV score is surpassed.
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At the beginning of each session, participants will complete 45 standard dot-probe trials as described above.
Participants' ABV on these trials will be calculated and set as their personal baseline (see below for ABV calculation).
In the following 165-training trials, participants will receive feedback: when their online-calculated ABV will be below their baseline screen background will be green whereas its color will be red when their online ABV score will be higher than their baseline.
Patients will be instructed to try to keep the background green for as long as possible.
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Sham Comparator: Control group - ABV with yoked sham feedback
Participants in this group will receive sham feedback that is unrelated to their ABV during the task, this is by presenting a feedback given to another participant in the training group (i.e., yoked sham feedback).
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Participants in this group will be exposed to the same task as in the active group but will receive sham feedback that is unrelated to their ABV during task performance.
They will be presented with a feedback that is yoked to the one given to a participant in the training group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of the total severity score of the CAPS-5 interview
Time Frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria.
This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated, with higher scores denoting higher symptom severity.
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Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of the total score of the PTSD Checklist (PCL-5)
Time Frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs.
Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD.
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Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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Change from baseline of the total score of the PHQ-9
Time Frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The PHQ-9 is a 9-item scale for depression symptoms (Kroenke, Spitzer, & Williams, 2001).
Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.
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Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Training Attention Bias Variability
Time Frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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Change in Attention Bias Variability from Baseline to Post-training measurement and follow-up.
ABV is calculated in four steps: 1) a trial-by trial moving average algorithm computed reaction times for all successive 10 neutral trial blocks and all successive 10 threat trial blocks, 2) successive attention bias scores were calculated by subtracting the first threat block average from the first neutral block average, the second threat block average from the second neutral block average, etc., forming a series of consecutive attention bias scores, 3) the standard deviation of these successive bias scores was then calculated, providing an index of variation in attention bias throughout the session, and 4) this standard deviation score was divided by the participant's mean overall reaction time
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Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The Credibility/Expectancy Questionnaire (CEQ)
Time Frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
This instrument consists of 6 items which derive two factors: expectancy for change and treatment credibility.
This CEQ will be used to explore whether expectancies or treatment credibility are related to outcomes.
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Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
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The CGI-I
Time Frame: 1 week post treatment, and 3-months follow-up post treatment
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Severity and improvement scale (CGI-I) will be used to assess participants global clinical condition.
The CGI-I is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.
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1 week post treatment, and 3-months follow-up post treatment
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The CGI-S
Time Frame: 1 week post treatment, and 3-months follow-up post treatment
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Severity and improvement scales (CGI-S ) will be used to assess participants global clinical condition.
The CGI-S is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.
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1 week post treatment, and 3-months follow-up post treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
- Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAU-ABV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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