Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tel Aviv University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline of the total severity score of the CAPS-5 interview
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Study design is a double-blind parallel-group RCT: two groups (ACT+feedback and ACT+sham feedback), and three assessment time points (pre-, post-treatment and follow up). The independent clinical evaluators, personnel staff who deliver the training, and participants are blind before and during treatment to group allocation, which is coded with a random number for each condition. Participants are randomly assigned to conditions in a 1:1 ratio using a list created with a random number generator. The random assignment list was created before enrollment to the study started. Group assignment is monitored by a staff member not involved in the study in any other capacity.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Attention Control Training (ACT) with ABV feedback (Behavioral)
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).
Intervention: Attention Control Training (ACT) with yoked sham feedback (Behavioral)
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)
Investigators
Yair Bar-Haim
Professor Yair Bar-Haim
Tel Aviv University