CompletedNot Applicable

ACTIVE: Activity Therapy to Increase Veteran Engagement

United States46 participantsStarted 2022-02-15

Plain-language summary

Depression is common after traumatic brain injury (TBI) and may have wide-ranging consequences. Post-TBI depression may impede reintegration into the family and community and lead to lower quality of life and heightened suicide risk. It may also interfere with rehabilitation. Yet, current treatments for post-TBI depression are based largely on expert opinion rather than evidence from rigorous studies. Behavioral activation (BA) is a promising intervention for post-TBI depression. It is a brief behavioral treatment that helps people define goals, create and execute plans to reach them, and engage in meaningful activities. BA has been tested in clinical trials since the 1970s and has been shown to reduce or prevent depression in populations with diverse medical conditions. However, BA has rarely been used or studied for treatment of depression in a TBI population. The investigators will conduct a study of BA with at least 40 Veterans with TBI and depressive symptoms in VA outpatient rehabilitation care. One group of Veterans will be randomly assigned to receive BA plus usual care. The BA program consists of six sessions delivered over three months at the VA (or Veterans' homes, if preferred) by an occupational therapist (OT). A second group of Veterans will be randomly assigned to receive usual care. The investigators will assess the feasibility of delivering the BA intervention in the rehabilitation setting and its acceptability to Veterans and staff. The research team will also assess participant responses to BA in the outcomes of depressive symptoms, community reintegration, and quality of life. Study findings will be used to guide the development of a future study of BA in a larger sample of Veterans with post-TBI depression. This study and future research may add a powerful clinical tool to rehabilitation services to lessen or prevent depression in Veterans with TBI. Reducing depression may in turn facilitate rehabilitation and enhance community reintegration, allowing Veterans to engage more fully in their families and communities.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veteran enrolled in the outpatient Rehabilitation Medicine Service at the Corporal Michael J. Crescenz VA Medical Center * Age of 21 years or older * Meet professional criteria for mild or moderate TBI * Confirmation of TBI diagnosis * Have a CES-D score at or above 16 at both the Telephone Screen and Baseline * Those taking antidepressants or other medications affecting mood or behavior must have been using these for at least three months, to allow for stabilization. * Those in psychotherapy can participate if therapy has been ongoing for three months or longer. * Veterans report current TBI-related symptoms on the Telephone Screen. * Speak English Exclusion Criteria: * A diagnosis of severe TBI * Psychosis * Aphasia * History of bipolar disorder * Presence of suicidal ideation with affirmative response on item 9 of the PHQ-9 * History of severe physical aggressiveness, judged by the clinical team * Currently receiving Cognitive Behavioral Therapy for depression * Dementia (determined on case-by-case basis based on physician diagnosis and participant's difficulty understanding interview questions)

What they're measuring

Depressive Symptom Scores on CES-D

Timeframe: 3 - 4 months

Trial details

NCT IDNCT04976621

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-04-16

Results submitted2025-04-28