ACTIVE: Activity Therapy to Increase Veteran Engagement (ACTIVE)

A Feasibility Study of Behavioral Activation in the Rehabilitation of Veterans With Post-TBI Depression

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 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.

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 indicies, (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 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.

At the baseline interview, the interviewer will review the study, answer questions, obtain Informed Consent, conduct screening for eligibility, and conduct the baseline interview. The interview will be conducted in the rehabilitation clinic office or home. Veterans who do not wish to continue with the study after the baseline interview will not be randomized. Within 48 hours of the baseline interview, eligible veterans will be randomized using the method of random permuted blocks and concealed allocation. Those randomized to BA will be contacted within 5 days by the interventionist and scheduled for the first session. They will receive the 6-session BA intervention (as well as treatment as usual [TAU]). Control participants will receive TAU only (which may include current medical and mental health treatments.) Three months after Baseline, a blinded interviewer will conduct the follow-up interview in person or on the phone with all veterans.

Care providers at the medical center will not have knowledge of the intervention or control condition assigned to individual participants. The research interviewer at the follow-up interview (the outcome assessor) also has no knowledge of the intervention or control condition assigned to individual participants.

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 an office at the VA rehabilitation clinic or the home, depending on the veteran's preference.

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

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 an office at the VA rehabilitation clinic or the home, depending on the veteran's preference.

Depressive symptoms will be measured by The Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a well-established 20-item screening instrument that shows good psychometric properties in TBI populations. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a Likert-type scale from 0 to 3. The total score is the sum across all 20 items. Total scores may range from 0 to 60, with higher scores indicating greater depressive symptoms.

Community reintegration will be measured by the Participation Assessment with Recombined Tools-Objective (PART-O-17). This 17-item tool is an objective measure of social functioning, developed from 3 existing community reintegration measures. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a 6-point Likert scale from 0 to 5. A mean score is computed. Mean Scores range from 0 to 5, with higher scores indicating better community reintegration.

Quality of life in TBI will be measured by The QoL-TBI instrument. This instrument is a 37-item patient-centered measure that captures the individual's perception of his/her health-related quality-of-life (HRQoL) in cognition, self-care, daily life and autonomy, social relationships, emotions, and physical problems. It will be administered at the Baseline interview and Follow-up interview (at 3 months). It uses a 5-point scale from "0 - Not at all" to "4- Very." Scores are summed, with higher scores indicating better quality of life.

Acceptability is measured by the Acceptance/Receipt Scale and is completed by the interventionist at the last intervention session. This is an 18-item tool with Likert scale response formats from 0 to 4. A mean score will be obtained and range from 0 to 4. Our criterion for acceptability is that at least 75% should score at 3.0 or higher.

Acceptability/Satisfaction with the intervention will be measured with the Acceptability/Satisfaction Scale and is completed by the participants who received Behavioral Activation after the last intervention session. This is a 12 item tool with a Likert scale response format from 0 to 4. A mean score will be obtained and range from 0 to 4. Our criterion for satisfaction is that at least 75% should score 3.0 or higher.

Recruitment is considered part of the process domain of feasibility. Recruitment will be measured by the percentage of veterans eligible for the study among those screened and the percentage willing to participate among those screened. Among those screened, our criterion for recruitment is that 50% or more will be eligible for the study and that at least 30% will be willing to participate.

Retention is considered part of the process domain of feasibility. Retention will be measured by the number of sessions completed over the total number of sessions (6). Among those who are enrolled, our criterion for retention is that 75% will attend 4 or more sessions and 75% will complete the study.

Treatment fidelity is considered part of the process domain of feasibility. This will be measured by the Treatment Fidelity Checklist, a 15 item tool with a 3-point scale with responses from 1 (poor) to 3 (excellent). The mean will be computed for the 15 items. Our criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.

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 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 Probable dementia based on a Montreal Cognitive Assessment (MoCA 7.1) score < 26 and difficulty understanding interview questions

Final data sets underlying all publications resulting from the research will be shared outside VA. A de-identified, anonymized dataset will be created and shared. A final dataset will be made available to the public upon receipt of a study-specific Data Use Agreement made in writing and following IRB and VA R&D regulations. Data will be provided electronically and per VA regulations for transferring data.

We will consult with a VA privacy officer and other regulatory specialists at the Corporal Michael Crescenz VA Medical Center, taking all recommended steps to insure that re-identifying participants from the final de-identified and anonymous dataset will not be possible. In addition, the Data Use Agreement will explicitly prohibit attempts to re-identify participants.