ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

NCT05242263 | Completed

• 1 other identifier: TAU-ABV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD; Attention Training; Cognitive Bias Modification; Attention Bias Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Other Outcomes (4)

• Post-Training Attention Bias Variability

  Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment

• The Credibility/Expectancy Questionnaire (CEQ)

  Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment

• The CGI-I

  1 week post treatment, and 3-months follow-up post treatment

Study Arms (2)

Training group - ACT with feedback

EXPERIMENTAL

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

Control group - ABV with yoked sham feedback

SHAM COMPARATOR

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

Interventions

Attention Control Training (ACT) with ABV feedback BEHAVIORAL

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.

Training group - ACT with feedback

Attention Control Training (ACT) with yoked sham feedback BEHAVIORAL

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.

Control group - ABV with yoked sham feedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

Related Publications (2)

• 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.

  PMID: 26206076 BACKGROUND

• 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.

  PMID: 26206075 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Yair Bar-Haim

Model Details: Participants are randomly assigned to either active or sham feedback in a 1:1 ratio.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 16, 2022
• Study Start: August 12, 2019
• Primary Completion: August 11, 2022
• Study Completion: December 10, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)