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Clinical Trials/NCT05242263
NCT05242263
Completed
N/A

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

Tel Aviv University1 site in 1 country60 target enrollmentAugust 12, 2019
ConditionsPTSD

Overview

Phase
N/A
Intervention
Not specified
Conditions
PTSD
Sponsor
Tel Aviv University
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline of the total severity score of the CAPS-5 interview
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2019
End Date
December 10, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yair Bar-Haim

Professor Yair Bar-Haim

Tel Aviv University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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