Attentional Bias Retraining in Veterans

Posttraumatic Stress Disorder Clinical Trial

— ABR  

Official title:

Attentional Bias Retraining in Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041572
• Other study ID #: 2012-05/MM/PROMISE 0001
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: October 31, 2017
• Start date: May 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2014
• Source: VA Pacific Islands Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	National Center for PTSD	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
VA Pacific Islands Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)