ACTIVE: Activity Therapy to Increase Veteran Engagement

Traumatic Brain Injury Clinical Trial

— ACTIVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04976621
• Other study ID #: D3578-P
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: June 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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

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

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the intervention rated by the interventionist	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.	3 months
Other	Veteran Acceptability/Satisfaction with the intervention	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.	3 months
Other	Recruitment	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.	16 months
Other	Retention	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.	18 months
Other	Treatment fidelity	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.	18 months
Primary	Depressive symptom scores on CES-D	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.	3 months
Secondary	Community reintegration scores on PART-O-17	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.	3 months
Secondary	Quality of life in TBI scores on QoL-TBI instrument	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.	3 months