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

Not Applicable

Completed

• Conditions: Distress; Anxiety; Depression; Postconcussive Symptoms
• Interventions: Behavioral: Present Centered Therapy; Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT01253044
• Lead Sponsor: Veterans Medical Research Foundation

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.

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2015-06-30
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-18
• Last Update Submitted: 2015-09-18
• Results First Posted: 2015-10-19
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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.

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Present Centered Therapy	Present Centered Therapy	12 weeks of individually delivered Present Centered Therapy
Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	12 weeks of individually delivered Acceptance and Commitment Therapy

Primary Outcome Measures

Name	Time	Method
Brief Symptom Inventory 18 (BSI-18)	Baseline and week 12	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.

Secondary Outcome Measures

Name	Time	Method
Sheehan Disability Inventory	Baseline and week 12	To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.

Trial Locations

Locations (6)

Walter Reed National Military Medical Center; 🇺🇸 Washington, District of Columbia, United States

Cincinnati VA Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Togus VA Medical Center; 🇺🇸 Augusta, Maine, United States

VA San Diego Healthcare System; 🇺🇸 La Jolla, California, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States

VA Puget Sound Health System; 🇺🇸 Seattle, Washington, United States