Back to resultsAttentional Bias Retraining in Veterans (ABR)
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attentional bias retraining
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility 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
Sites / Locations
- National Center for PTSD
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Attentional Bias Retraining
Arm Description
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.
Outcomes
Primary Outcome Measures
Post-traumatic Checklist - Military version (PCL-M)
PCL-M assess the 17-cardinal symptoms of PTSD.
Secondary Outcome Measures
Attentional bias scores
Attentional bias scores represent participants cognitive bias to orient towards trauma-relevant information more quickly than neutral information.
Full Information
NCT ID
NCT02041572
First Posted
January 15, 2014
Last Updated
October 31, 2017
Sponsor
VA Pacific Islands Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT02041572
Brief Title
Attentional Bias Retraining in Veterans
Acronym
ABR
Official Title
Attentional Bias Retraining in Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Pacific Islands Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attentional Bias Retraining
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attentional bias retraining
Intervention Description
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 Measure Information:
Title
Post-traumatic Checklist - Military version (PCL-M)
Description
PCL-M assess the 17-cardinal symptoms of PTSD.
Time Frame
Change from Baseline and Post-treatment (1 month after last training session)
Secondary Outcome Measure Information:
Title
Attentional bias scores
Description
Attentional bias scores represent participants cognitive bias to orient towards trauma-relevant information more quickly than neutral information.
Time Frame
Change from Baseline and Post-treatment (1 month after last training session)
Other Pre-specified Outcome Measures:
Title
Daily of PTSD symptoms, specifically hyperarousal and intrusive symptoms (nightmares, reenactments, and triggered and untriggered recall)
Description
Participants filled out daily symptom log nightly
Time Frame
Change from Baseline and Post-treatment (1 month after last training session)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret-Anne Mackintosh, PhD
Organizational Affiliation
National Center for PTSD/PHREI
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for PTSD
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data
Learn more about this trial
Attentional Bias Retraining in Veterans
We'll reach out to this number within 24 hrs