Clinical trial NCT04976621: ACTIVE: Activity Therapy to Increase Veteran Engagement
Official title: A Feasibility Study of Behavioral Activation in the Rehabilitation of Veterans With Post-TBI Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: rehabilitation
depression
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Thomas Jefferson University
First posted: 2021-07-26
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, by VA Video Connect, or in the 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.
Primary purpose: TREATMENT

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 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 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.

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)

Primary outcomes:
measure: Depressive symptom scores on CES-D
timeFrame: 3 months
Secondary outcomes:
measure: Community reintegration scores on PART-O-17
timeFrame: 3 months
measure: Quality of life in TBI scores on QoL-TBI instrument
timeFrame: 3 months
Other outcomes:
measure: Acceptability of the intervention rated by the interventionist
timeFrame: 3 months
measure: Veteran Acceptability/Satisfaction with the intervention
timeFrame: 3 months
measure: Recruitment
timeFrame: 16 months
measure: Retention
timeFrame: 18 months
measure: Treatment fidelity
timeFrame: 18 months
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Helene J Moriarty, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: