Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans
Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
1 other identifier
interventional
160
1 country
6
Brief Summary
This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize that ACT will be more effective than PCT at reducing emotional distress and improving functioning. We further hypothesize that both interventions will be highly acceptable to participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
October 19, 2015
CompletedOctober 19, 2015
September 1, 2015
2.8 years
December 1, 2010
June 30, 2015
September 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Symptom Inventory 18 (BSI-18)
To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.
Baseline and week 12
Secondary Outcomes (1)
Sheehan Disability Inventory
Baseline and week 12
Study Arms (2)
Acceptance and Commitment Therapy
EXPERIMENTAL12 weeks of individually delivered Acceptance and Commitment Therapy
Present Centered Therapy
ACTIVE COMPARATOR12 weeks of individually delivered Present Centered Therapy
Interventions
Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Eligibility Criteria
You may qualify if:
- Previous deployment to OEF or OIF
- Current distress and impairment \[at least one Diagnostic and Statistical Manual version IV (DSM-IV) anxiety or depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI) or post-concussive symptoms (PCS) as determined by a positive traumatic brain injury (TBI) screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS\].
- Capable of giving informed consent.
You may not qualify if:
- Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the Montreal Cognitive Assessment (MoCA; excluded if score \< 26).
- Severe psychopathology (psychosis, bipolar illness, urgent suicidality or self-injurious behavior) or untreated substance dependence in the past month.
- Anticipated change in pharmacologic intervention. Patients may stay on their current medications during the study but will be asked to refrain from beginning or altering medication use during the study to the extent possible.
- Other psychotherapy focusing on the same target symptoms. Patients may attend self-help groups or treatment for other types of problems (e.g., couples counseling) but not other treatment for the same presenting problems.
- Anticipated deployment or other circumstance that would interfere with completion of all study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
VA San Diego Healthcare System
La Jolla, California, 92161, United States
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, 20889, United States
Togus VA Medical Center
Augusta, Maine, 04330, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
VA Puget Sound Health System
Seattle, Washington, 98108, United States
Related Publications (1)
Bomyea J, Lang AJ, Schnurr PP. TBI and Treatment Response in a Randomized Trial of Acceptance and Commitment Therapy. J Head Trauma Rehabil. 2017 Sep/Oct;32(5):E35-E43. doi: 10.1097/HTR.0000000000000278.
PMID: 28060206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ariel Lang
- Organization
- VA San Diego Healthcare System and UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel J Lang, PhD
University California San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
November 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 19, 2015
Results First Posted
October 19, 2015
Record last verified: 2015-09