Attentional Bias Retraining in Veterans (ABR)

October 31, 2017 updated by: VA Pacific Islands Health Care System
The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)

  • 1.1 Computerized assessment & retraining programs
  • 1.2 Procedures and measures

Aim 2: Implement in pilot sample (Phase 2)

  • 2.1: Assess feasibility and tolerability
  • 2.2: Collect pilot data to plan future studies
  • 2.3: Efficacy estimates based on changes in response time to dot probe task

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • National Center for PTSD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Participated in ground combat operations in Vietnam
  • Scored 40 - 80 on PTSD Checklist - Military version
  • Availability and willingness to attend 2x weekly computer sessions for 6 weeks

Exclusion Criteria:

  • Active substance dependence
  • Significant cognitive impairment
  • Current and active suicidal or homicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Attentional Bias Retraining
Each participant receives 12 sessions. The first three sessions are baseline (assessment only) sessions. The last four sessions must be treatment sessions. The attentional bias intervention starts randomly on sessions 4 - 8, and continues until the end of the 12 sessions.
Behavioral: Attentional bias retraining
Participants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-traumatic Checklist - Military version (PCL-M)
Time Frame: Change from Baseline and Post-treatment (1 month after last training session)
PCL-M assess the 17-cardinal symptoms of PTSD.
Change from Baseline and Post-treatment (1 month after last training session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attentional bias scores
Time Frame: Change from Baseline and Post-treatment (1 month after last training session)
Attentional bias scores represent participants cognitive bias to orient towards trauma-relevant information more quickly than neutral information.
Change from Baseline and Post-treatment (1 month after last training session)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily of PTSD symptoms, specifically hyperarousal and intrusive symptoms (nightmares, reenactments, and triggered and untriggered recall)
Time Frame: Change from Baseline and Post-treatment (1 month after last training session)
Participants filled out daily symptom log nightly
Change from Baseline and Post-treatment (1 month after last training session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Pacific Islands Health Care System

Investigators

  • Principal Investigator: Margaret-Anne Mackintosh, PhD, National Center for PTSD/PHREI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-05/MM/PROMISE 0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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