Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Veterans Medical Research Foundation.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Ariel Lang, PhD, Veterans Medical Research Foundation Identifier:
First received: December 1, 2010
Last updated: March 7, 2013
Last verified: March 2013

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.

Condition Intervention
Postconcussive Symptoms
Behavioral: Acceptance and Commitment Therapy
Behavioral: Present Centered Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans

Resource links provided by NLM:

Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Brief Symptom Inventory 18 (BSI-18) [ Time Frame: Baseline through end of treatment ] [ Designated as safety issue: No ]
    To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index at the end of treatment.

Secondary Outcome Measures:
  • Sheehan Disability Inventory [ Time Frame: Baseline through end of treatment ] [ Designated as safety issue: No ]
    To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment.

Estimated Enrollment: 158
Study Start Date: November 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acceptance and Commitment Therapy Behavioral: Acceptance and Commitment Therapy
Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Other Name: ACT
Active Comparator: Present Centered Therapy Behavioral: Present Centered Therapy
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Other Name: PCT

Detailed Description:

The proposed study is a randomized controlled trial (RCT) of Acceptance and Commitment Therapy (ACT) as compared to a control psychotherapy, Present Centered Therapy (PCT), for individuals with distress and impairment who deployed as part of Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). ACT was selected for study because it has a number of advantages for this population. It is not tied to any particular symptom constellation, so it can be applied to a variety of presenting concerns (Hayes, Luoma, et al., 2006; Öst, 2008, Powers et al., 2009), resulting in reduced training burden for clinicians and less need for applying sequential treatments to address co-morbidities. ACT has good face validity (i.e., "it makes sense") and conveys a compelling message to young Service Members and Veterans. ACT asks individuals to move forward in accordance with one's values regardless of limitations rather than struggling against those limitations. ACT appears to be acceptable to patients (mean attrition of 15.4% in 13 RCTs (Öst, 2008). ACT is being widely disseminated without adequate evidence of its effectiveness for this important population.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previous deployment to OEF or OIF
  • Current distress and impairment (at least one DSM-IV anxiety or depressive disorder as determined by the MINI or PCS as determined by a positive TBI screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS).
  • Capable of giving informed consent.

Exclusion Criteria:

  • Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the 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 [e.g., PE or CPT for PTSD, CBT for depression, cognitive rehabilitation for mild TBI). 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01253044

United States, California
VA San Diego Healthcare System
La Jolla, California, United States, 92161
United States, District of Columbia
Walter Reed National Military Medical Center
Washington, District of Columbia, United States, 20889
United States, Maine
Togus VA Medical Center
Augusta, Maine, United States, 04330
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220
United States, Washington
VA Puget Sound Health System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Veterans Medical Research Foundation
Principal Investigator: Ariel J Lang, PhD University California San Diego
  More Information

No publications provided

Responsible Party: Ariel Lang, PhD, Professor, Veterans Medical Research Foundation Identifier: NCT01253044     History of Changes
Other Study ID Numbers: W81XWH-08-2-0159
Study First Received: December 1, 2010
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Veterans Medical Research Foundation:

Additional relevant MeSH terms:
Post-Concussion Syndrome
Brain Concussion
Brain Diseases
Brain Injuries
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating processed this record on March 03, 2015