ACTIVE: Activity Therapy to Increase Veteran Engagement

NCT ID: NCT04976621

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-06-03

Brief 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.

Detailed Description

Objectives: Nearly 400,000 Veterans have been diagnosed with traumatic brain injury (TBI) since 2000, representing up to 22% of combat casualties. Depression is one of the most prevalent and serious of TBI sequelae. Post-TBI depression adversely affects rehabilitation, treatment adherence, community reintegration (CR), quality of life (QOL), social relationships, and caregiver burden. Yet, post-TBI depression remains under-assessed, undertreated, and under-studied. No clinical guidelines for post-TBI depression treatment exist, and current treatment is largely based on expert opinion rather than evidence from controlled clinical trials.

A promising therapeutic approach to post-TBI depression is Behavioral Activation (BA), a brief and pragmatic treatment rigorously tested since the 1970s in clinical trials for depression in diverse clinical populations. BA helps individuals set goals, create plans, and engage in activities that improve mood and maintain social connectedness - making it well-suited to treating depression in a TBI population that struggles to set goals and is prone to social isolation. BA can accommodate hallmark deficits of TBI such as deficits in memory, organization, planning, initiation, emotion regulation, and interpersonal functioning. It can be delivered by professionals routinely available in VA outpatient rehabilitation services (e.g., occupational therapists, nurses, psychologists, social workers) and, therefore, can be deployed in rehabilitation settings.

The proposed research will assess the feasibility of a BA protocol adapted for post-TBI depression in an outpatient VA rehabilitation setting. Specific study objectives are to: (1) assess BA's acceptability to Veterans and staff and other feasibility indices, (2) provide preliminary evidence of participant response in the outcomes of depressive symptoms, CR, and QOL at the 3-month follow-up interview, (3) develop the BA protocol and manual to be tested in a larger randomized controlled trial (RCT) in the future, and (4) explore engagement in activity as the mechanism that underlies BA intervention effects on outcomes.

Research Design: This feasibility study includes a pilot randomized controlled trail to examine participant response.

Methodology: This feasibility study will enroll at least 40 male and female Veterans receiving care at a VAMC Rehabilitation Medicine Service and meeting study criteria for TBI and depression. Veterans will be randomly assigned to BA plus treatment as usual (TAU) or control (TAU). The BA program consists of six sessions delivered over 3 months at the VA (or the Veteran's home, as preferred by Veteran) by an occupational therapist (OT). All Veterans are interviewed at baseline before randomization and 3 months later by a blinded interviewer. Both interviews assess Veterans' depressive symptoms, CR, and QOL, using standardized instruments. Feasibility will be assessed in six domains: acceptability to Veterans and clinic staff; process (recruitment, refusal, and retention rates; study completion; eligibility criteria; and number of sessions attended); practicality (resources and constraints imposed by the setting); safety; participant comprehension of interviews and the intervention; and research burden (length of interviews, participant fatigue, and emotional distress). After the follow-up interview, phone interviews with BA participants and with clinic staff will be conducted to capture acceptability and their experience with BA. These qualitative and quantitative methods are designed to test the feasibility of a future RCT, identify the barriers and facilitators to implementation of BA in the rehabilitation setting, and describe Veterans' experiences with BA.

Impact/Significance: This study and line of research has the potential to advance knowledge by identifying a feasible and efficacious approach to preventing and/or mitigating depression among Veterans with TBI, a clinical population at high risk for depression and its sequelae. Findings will be used to inform the development of a future RCT powered to test BA's efficacy in a larger sample of Veterans with post-TBI depression.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Behavioral Activation (BA) intervention group

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.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. BA protocol components include: goal setting (especially for activities that promote social connectedness), creation of a plan (broken down into steps), strategies for implementation of steps, identification of potential barriers, tactics to overcome them, activity monitoring and scheduling, and emotion regulation strategies. 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.

Treatment as Usual

Intervention Type: OTHER

Treatment as Usual refers to usual care provided by the VA medical center.

Treatment as Usual Control Group

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

Group Type: OTHER

Treatment as Usual

Intervention Type: OTHER

Treatment as Usual refers to usual care provided by the VA medical center.

Interventions

Behavioral Activation

BA is a brief behavioral treatment that helps people define goals, create and execute plans to attain them, and engage in meaningful activities. BA protocol components include: goal setting (especially for activities that promote social connectedness), creation of a plan (broken down into steps), strategies for implementation of steps, identification of potential barriers, tactics to overcome them, activity monitoring and scheduling, and emotion regulation strategies. 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.

Intervention Type: BEHAVIORAL

Treatment as Usual

Treatment as Usual refers to usual care provided by the VA medical center.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helene J Moriarty, PhD RN

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Locations

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D3578-P

Identifier Type: -

Identifier Source: org_study_id