Behavioral Activation for Depression in Veterans with Traumatic Brain Injury
(ACTIVE Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Helene J Moriarty, PhD RN
Principal Investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Eligibility Criteria
This trial is for Veterans aged 21 or older with mild to moderate TBI and depression, enrolled in outpatient rehab at the Corporal Michael J. Crescenz VA Medical Center. They must have stable medication use if on antidepressants, speak English, and not be receiving Cognitive Behavioral Therapy for depression or have severe cognitive impairments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Behavioral Activation (BA) treatment over 6 sessions delivered over 3 months
Follow-up
Participants are monitored for depressive symptoms, community reintegration, and quality of life at the 3-month follow-up interview
Extension
Phone interviews with BA participants and clinic staff to capture acceptability and experience with BA
Treatment Details
Interventions
- Behavioral Activation
Behavioral Activation is already approved in United States, China, European Union for the following indications:
- Depression
- Anxiety in older adults undergoing cardiac procedures
- Loneliness in older adults
- Depression
- Depression
- Anxiety
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Thomas Jefferson University
Collaborator