ACTIVE: Activity Therapy to Increase Veteran Engagement

NCT04976621 | Completed Results

• 1 other identifier: D3578-P
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

rehabilitation; depression; veterans

Outcome Measures

Primary Outcomes (1)

• 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 - 4 months

Secondary Outcomes (2)

• Community Reintegration Scores on PART-O-17

  3 - 4 months

• Quality of Life in TBI Scores on QoL-TBI Instrument

  3 - 4 months

Other Outcomes (5)

• Acceptability of the Intervention Rated by the Interventionist

  3 - 4 months

• Veteran Acceptability/Satisfaction With the Intervention

  3 - 4 months

• Recruitment

  16 months

Study Arms (2)

Behavioral Activation (BA) intervention group

EXPERIMENTAL

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: Behavioral Activation; Other: Treatment as Usual

Treatment as Usual Control Group

OTHER

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

Other: Treatment as Usual

Interventions

Behavioral Activation 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.

Behavioral Activation (BA) intervention group

Treatment as Usual OTHER

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

Behavioral Activation (BA) intervention group; Treatment as Usual Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Helene Moriarty, PhD, RN
• Organization: Corporal Michael J. Crescenz VA Medical Center

helene.moriarty@va.gov

610-519-5735

Study Officials

• Helene J Moriarty, PhD RN

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 26, 2021
• Study Start: February 15, 2022
• Primary Completion: April 16, 2024
• Study Completion: June 3, 2024
• Last Updated: December 12, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The IDP will be shared starting six months after the publication.
• Access Criteria: 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.

Locations

US (1)