This trial is active, not recruiting.

Conditions distress, anxiety, depression, postconcussive symptoms
Treatments acceptance and commitment therapy, present centered therapy
Sponsor Veterans Medical Research Foundation
Start date November 2010
End date May 2013
Trial size 158 participants
Trial identifier NCT01253044, W81XWH-08-2-0159


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
acceptance and commitment therapy ACT
Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
(Active Comparator)
present centered therapy PCT
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).

Primary Outcomes

Brief Symptom Inventory 18 (BSI-18)
time frame: Baseline through end of treatment

Secondary Outcomes

Sheehan Disability Inventory
time frame: Baseline through end of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
Principal investigator Ariel J Lang, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Veterans Medical Research Foundation.