Attentional Bias Retraining in Veterans (ABR)

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: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Attentional bias retraining

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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	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)	Participants filled out daily symptom log nightly	Change from Baseline and Post-treatment (1 month after last training session)

Collaborators and Investigators

• Sponsor: VA Pacific Islands Health Care System
• Investigators: Principal Investigator: Margaret-Anne Mackintosh, PhD, National Center for PTSD/PHREI

Study record dates

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: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• 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