ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

NCT ID: NCT05242263

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-12
• Study Completion Date: 2022-12-10

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Attention Control Training (ACT) with ABV feedback

Intervention Type: 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.

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).

Group Type: SHAM_COMPARATOR

Attention Control Training (ACT) with yoked sham feedback

Intervention Type: 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.

Interventions

Attention Control Training (ACT) with ABV feedback

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.

Intervention Type: BEHAVIORAL

Attention Control Training (ACT) with yoked sham feedback

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Yair Bar-Haim

Professor Yair Bar-Haim

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel Aviv University

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 26206076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26206075 (View on PubMed)

Other Identifiers

TAU-ABV

Identifier Type: -

Identifier Source: org_study_id