Depression Clinical Trial
Official title:
Initial Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Distress and Impairment in OEF/OIF Veterans
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Togus VA Medical Center | Augusta | Maine |
United States | Cincinnati VA Medical Center | Cincinnati | Ohio |
United States | Durham VA Medical Center | Durham | North Carolina |
United States | VA San Diego Healthcare System | La Jolla | California |
United States | VA Puget Sound Health System | Seattle | Washington |
United States | Walter Reed National Military Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Veterans Medical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Sheehan Disability Inventory | 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. | Baseline and week 12 | No |
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