Behavioral Activation for Depression in Veterans with Traumatic Brain Injury

(ACTIVE Trial)

Overseen By Laraine Winter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antidepressants

Disqualifiers: Severe TBI, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

46 Participants Needed

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

I have been on my current mood or behavior medication for at least three months.

Veteran enrolled in the outpatient Rehabilitation Medicine Service at the Corporal Michael J. Crescenz VA Medical Center

Confirmation of TBI diagnosis

Exclusion Criteria

Psychosis

Presence of suicidal ideation with affirmative response on item 9 of the PHQ-9

I have difficulty with speaking or understanding language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation (BA) treatment over 6 sessions delivered over 3 months

12 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for depressive symptoms, community reintegration, and quality of life at the 3-month follow-up interview

3 months

1 follow-up interview (in-person or virtual)

Extension

Phone interviews with BA participants and clinic staff to capture acceptability and experience with BA

1-2 weeks

Treatment Details

Interventions

• Behavioral Activation

Trial Overview The study tests Behavioral Activation (BA), a short treatment aiming to reduce post-TBI depression by setting goals and engaging in activities. Participants will either receive BA plus usual care or just usual care, with outcomes like depressive symptoms and quality of life measured.

Participant Groups

Group I: Treatment as Usual Control Group Experimental Treatment 1 Intervention

Participants in the Control group receive treatment as usual (TAU), which is usual care provided by the VA medical center.

Group II: Behavioral Activation (BA) intervention group Experimental Treatment 2 Interventions

Participants in the BA group will receive BA treatment and treatment as usual. BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. The BA intervention will be delivered in 6 sessions over 3 months by Occupational Therapists trained in BA for post-TBI depression. BA sessions will be conducted in person in an office at the VA rehabilitation clinic, virtually by VA Video Connect, or in person in the home, depending on the veteran's preference.

Behavioral Activation is already approved in United States, China, European Union for the following indications:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+