ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Attention Control Training (ACT) with yoked sham feedback; Behavioral: Attention Control Training (ACT) with ABV feedback

• Registration Number: NCT05242263
• Lead Sponsor: Tel Aviv University

Brief Summary

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

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 Timeline

• Study Start: 2019-08-12
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-16
• Primary Completion: 2022-08-11
• Study Completion: 2022-12-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group - ABV with yoked sham feedback	Attention Control Training (ACT) 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).
Training group - ACT with feedback	Attention Control Training (ACT) with ABV 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline of the total severity score of the CAPS-5 interview	Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel