ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Attention Control Training (ACT) with ABV feedback
* Behavioral: Attention Control Training (ACT) with yoked sham feedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to either active or sham feedback in a 1:1 ratio.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group - ACT with feedback<br>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. | Behavioral: Attention Control Training (ACT) with ABV feedback<br>* 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.<br>|
| Sham Comparator: Control group - ABV with yoked sham feedback<br>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). | Behavioral: Attention Control Training (ACT) with yoked sham feedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the total severity score of the CAPS-5 interview | 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. | Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the total score of the PTSD Checklist (PCL-5) | 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. | Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment | 
| Change from baseline of the total score of the PHQ-9 | 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. | Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Attention Training, Cognitive Bias Modification, Attention Bias Modification