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Attentional Bias Retraining in Veterans (ABR)

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ClinicalTrials.gov Identifier: NCT02041572
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
VA Pacific Islands Health Care System

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Attentional bias retraining Not Applicable

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  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Attentional Bias Retraining in Veterans
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2015

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041572


Locations
United States, Hawaii
National Center for PTSD
Honolulu, Hawaii, United States, 96819
Sponsors and Collaborators
VA Pacific Islands Health Care System
Investigators
Principal Investigator: Margaret-Anne Mackintosh, PhD National Center for PTSD/PHREI

Responsible Party: VA Pacific Islands Health Care System
ClinicalTrials.gov Identifier: NCT02041572     History of Changes
Other Study ID Numbers: 2012-05/MM/PROMISE 0001
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: January 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders