Clinical trial NCT05242263: ACT With Feedback for Post Traumatic Stress Disorder (PTSD)
Official title: Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Attention Training
Cognitive Bias Modification
Attention Bias Modification
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either active or sham feedback in a 1:1 ratio.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline of the total severity score of the CAPS-5 interview
timeFrame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Secondary outcomes:
measure: Change from baseline of the total score of the PTSD Checklist (PCL-5)
timeFrame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
measure: Change from baseline of the total score of the PHQ-9
timeFrame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
Other outcomes:
measure: Post-Training Attention Bias Variability
timeFrame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment
measure: The CGI-I
timeFrame: 1 week post treatment, and 3-months follow-up post treatment
measure: The CGI-S
timeFrame: 1 week post treatment, and 3-months follow-up post treatment
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References:
citation: 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.
citation: 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.