Attentional Bias Retraining in Veterans

NCT02041572 | Completed

• 1 other identifier: 2012-05/MM/PROMISE 0001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Attentional bias scores

  Change from Baseline and Post-treatment (1 month after last training session)

Other Outcomes (1)

• Daily of PTSD symptoms, specifically hyperarousal and intrusive symptoms (nightmares, reenactments, and triggered and untriggered recall)

  Change from Baseline and Post-treatment (1 month after last training session)

Study Arms (1)

Attentional Bias Retraining

OTHER

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

Interventions

Attentional bias retraining BEHAVIORAL

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.

Attentional Bias Retraining

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Pacific Islands Health Care System: lead

Study Sites (1)

National Center for PTSD

Honolulu, Hawaii, 96819, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Margaret-Anne Mackintosh, PhD

  National Center for PTSD/PHREI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The transition point from the assessment only version of the attention bias program to the retraining/ bias correction version was randomized at the participant level and occurred between weeks 4 and 7 of the 10-week study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2014-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)