Behavioral Activation for Depression in Veterans with Traumatic Brain Injury

(ACTIVE Trial)

Overseen By Laraine Winter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antidepressants

Disqualifiers: Severe TBI, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Behavioral Activation (BA) to assist Veterans with traumatic brain injuries (TBI) who experience depression. BA is a therapy that helps individuals set goals and engage in meaningful activities, potentially improving mood and quality of life. The study will compare Veterans receiving BA alongside usual care to those receiving only usual care. Veterans qualify if they have mild to moderate TBI and ongoing symptoms related to the injury. The goal is to determine if BA can positively impact depression management for these Veterans. As an unphased trial, this study provides Veterans the opportunity to explore a potentially beneficial therapy tailored to their needs.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but if you're on antidepressants or other mood-related medications, you need to have been taking them for at least three months before joining the trial.

What prior data suggests that Behavioral Activation is safe for Veterans with post-TBI depression?

Research has shown that Behavioral Activation (BA) is generally well-tolerated and positively impacts people with depression. One study found that BA can be as effective as cognitive-behavioral therapy in reducing depression symptoms, but it is gentler on the brain, making it suitable for individuals with brain injuries.

In another study, 66.7% of participants experienced a significant reduction in their depression symptoms, with symptoms cut in half. Additionally, about 44.4% of participants saw their symptoms become very low, reaching remission.

These findings suggest that BA is not only effective but also safe for people with depression, even those with a traumatic brain injury. Reports of major negative side effects are absent, making BA a promising option for managing depression in those with TBI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation (BA) for veterans with depression and traumatic brain injury (TBI) because it offers a unique, goal-oriented approach to treatment. Unlike standard options that might focus primarily on medication or talk therapy, BA empowers individuals to set personal goals and develop actionable plans, fostering engagement in meaningful activities. This is particularly promising for veterans, as the treatment can be tailored to their preferences, being offered in person or virtually, ensuring accessibility and comfort. Additionally, Occupational Therapists specially trained in BA deliver the sessions, which could enhance the effectiveness for those dealing with post-TBI depression.

What evidence suggests that Behavioral Activation might be an effective treatment for post-TBI depression?

Research has shown that Behavioral Activation (BA), which participants in this trial may receive, can help reduce depression in many people. BA encourages individuals to set goals and engage in meaningful activities, boosting mood and enhancing daily life. One study found that BA can be as effective as cognitive-behavioral therapy for treating depression, but it is often easier for people to follow. For those with a traumatic brain injury (TBI), early research suggests that BA can significantly improve symptoms of depression. Although BA hasn't been widely studied specifically for depression after a TBI, its success in other groups makes it a promising option. This treatment could potentially improve the quality of life for veterans dealing with depression after a TBI. ^{1 2 3 6 7}

Who Is on the Research Team?

Helene J Moriarty, PhD RN

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for Veterans aged 21 or older with mild to moderate TBI and depression, enrolled in outpatient rehab at the Corporal Michael J. Crescenz VA Medical Center. They must have stable medication use if on antidepressants, speak English, and not be receiving Cognitive Behavioral Therapy for depression or have severe cognitive impairments.

Inclusion Criteria

I have been on my current mood or behavior medication for at least three months.

Veteran enrolled in the outpatient Rehabilitation Medicine Service at the Corporal Michael J. Crescenz VA Medical Center

Confirmation of TBI diagnosis

Exclusion Criteria

Psychosis

Presence of suicidal ideation with affirmative response on item 9 of the PHQ-9

I have difficulty with speaking or understanding language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation (BA) treatment over 6 sessions delivered over 3 months

12 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for depressive symptoms, community reintegration, and quality of life at the 3-month follow-up interview

3 months

1 follow-up interview (in-person or virtual)

Extension

Phone interviews with BA participants and clinic staff to capture acceptability and experience with BA

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation

Trial Overview The study tests Behavioral Activation (BA), a short treatment aiming to reduce post-TBI depression by setting goals and engaging in activities. Participants will either receive BA plus usual care or just usual care, with outcomes like depressive symptoms and quality of life measured.

How Is the Trial Designed?

Group I: Treatment as Usual Control Group Experimental Treatment 1 Intervention

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

Group II: Behavioral Activation (BA) intervention group Experimental Treatment 2 Interventions

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 Activation is already approved in United States, China, European Union for the following indications:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31793383/

Behavioural activation therapy to improve participation in ... Behavioural Activation (BA) could help because it has been demonstrated to be as effective as cognitive-behaviour therapy but is less cognitively demanding.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109519300291

Behavioral Activation Augmented With Mobile Technology ... A randomized controlled trial for depression or anxiety after moderate to severe traumatic brain injury (TBI), which will test 2 treatments based on behavioral ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264713/

Comparing the effectiveness of behavioral activation in ... The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...

4. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1002/jcv2.70030

Evaluating Brief Behavioural Activation for depression in ... Brief Behavioural Activation (Brief BA) is a successful, values-based intervention for managing depression in neurotypical adolescents. This ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02602340

Neurocognitive Predictors of Behavioral Therapy ... This project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of depression that will predict the effectiveness of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2864457/

Treatment for Depression after Traumatic Brain Injury Response rate (50% drop in HAM-D) was 66.7%, and remission rate (final HAM-D ≤7) was 44.4%; there was significant improvement in cognition on MMSE. Khateb et al ...

7. withpower.com withpower.com/trial/phase-brain-injuries-9-2021-b4dae

Behavioral Activation for Depression in Veterans with ... Trial Overview The study tests Behavioral Activation (BA), a short treatment aiming to reduce post-TBI depression by setting goals and engaging in activities.