Behavioral Activation for Functional Independence in Older Veterans

(ACTIVaTE Trial)

Overseen By Meaghan A Kennedy, MD MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-English, Cognitive impairment, Severe depression, Schizophrenia, Psychosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older Veterans maintain independence by testing a program called ACTIVaTE (Behavioral Activation for Independence in Older Veterans), which encourages engagement in meaningful activities. The goal is to improve physical, cognitive, and social functioning, reducing the risk of long-term care or hospitalization. The trial will compare this new program to usual care to determine its benefits for participants. Ideal candidates are Veterans living at home who are at risk of losing the ability to perform daily activities independently. As an unphased trial, participants contribute to innovative research that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants with unstable health conditions or those receiving certain therapies, so it's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this behavioral activation program is safe for older Veterans?

Research shows that behavioral activation, the treatment under study, is generally easy for people to handle. This method originates from a therapy initially developed for depression and helps individuals engage in activities they find meaningful. As it is neither a medication nor a procedure, the risk of physical side effects remains low.

Previous studies indicate that participants find behavioral activation acceptable and often describe it as a positive experience, with very few negative effects. The process involves talking and planning, making harm unlikely.

This trial aims to determine if older Veterans can benefit from this treatment through video calls. Since behavioral activation has been used safely for other purposes, it is expected to be safe for Veterans in this study as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACTIVaTE because it introduces a novel approach to enhancing functional independence in older veterans through behavioral activation. Unlike traditional methods that may focus on medication or physical therapy, ACTIVaTE emphasizes psychological strategies to motivate and engage veterans in activities that promote independence. This behavioral technique targets improving mood and daily functioning, potentially offering a holistic benefit by addressing both mental and physical health. By empowering veterans to take charge of their daily activities, ACTIVaTE aims to improve quality of life in a way that existing treatments may not fully address.

What evidence suggests that this program is effective for supporting independence in older Veterans?

Research has shown that behavioral activation, included in the ACTIVaTE intervention for this trial, can help older adults maintain independence. An early study reduced depression symptoms in 20 older adults over five weeks. This method encourages participation in activities aligned with personal values, potentially enhancing physical health, cognitive skills, and social life. Behavioral activation is associated with improved mood and reduced loneliness, both crucial for independence. These early findings suggest it could be a promising approach to help older Veterans remain independent and avoid hospital or long-term care. ^{2 3 4 6 7}

Who Is on the Research Team?

Meaghan A Kennedy, MD MPH

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

This trial is for older Veterans who may struggle with day-to-day activities due to chronic health issues. They must be at risk of losing their independence, receiving VA primary care, living outside nursing homes, and able to give consent. Those with severe depression or certain mental health conditions, upcoming surgeries, or in hospice care cannot join.

Inclusion Criteria

Community-dwelling (living outside nursing homes)

Receiving VA primary care

At risk for functional decline (VES-13 score 3)

Exclusion Criteria

I do not have thoughts of harming myself.

Unstable physical or mental health condition: likely substance use disorder (positive TICS)

Unstable physical or mental health condition: ongoing evaluation of new cardiac or respiratory symptoms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Adaptation of the behavioral activation program for older Veterans, including feedback from Veterans and VA staff

1 year

Open Trial

Preliminary acceptability testing of the ACTIVaTE intervention with 10 Veterans

6 weeks

Weekly virtual sessions

Randomized Controlled Trial

Pilot RCT of ACTIVaTE versus usual care in 48 Veterans to assess feasibility and acceptability

12 weeks

Baseline, 8 weeks, and 12 weeks assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention control
• Behavioral Activation for Independence in Older Veterans (ACTIVaTE)

Trial Overview The study tests a program called ACTIVaTE delivered via video telehealth against an education program about staying active. It aims to improve physical, cognitive, and social functions by increasing engagement in meaningful activities. The effectiveness will be measured through a randomized controlled trial involving 48 Veterans.

How Is the Trial Designed?

Group I: Usual care Experimental Treatment 1 Intervention

In Aim 3, 24 participants will be randomized to a usual care arm.

Group II: Open trial Experimental Treatment 1 Intervention

In Aim 2, all 10 participants will receive the ACTIVaTE intervention.

Group III: ACTIVaTE intervention Experimental Treatment 2 Interventions

In Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention.

Behavioral Activation for Independence in Older Veterans (ACTIVaTE) is already approved in United States for the following indications:

Approved in United States as Behavioral Activation for:

• Depression
• Functional limitations in older adults

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Behavioral Activation (BA) treatment significantly reduced depressive symptoms in older adults with mild to moderate cognitive impairment, based on a study of 50 participants over 4 weeks.

The study found no significant impact of BA on quality of life, indicating that while it helps with depression, it may not improve overall life satisfaction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of behavioral activation therapy with inpatient geriatric psychiatry patients. Snarski, M., Scogin, F., DiNapoli, E., et al.[2022]

Behavioral activation (BA) is an effective treatment for depression that focuses on increasing positive reinforcement in the environment to promote healthy behaviors and reduce avoidance.

BA can be integrated with other cognitive-behavioral strategies, making it versatile for various clinical populations and settings, highlighting its potential for broader application in treating emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. Farchione, TJ., Boswell, JF., Wilner, JG.[2019]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its potential as a treatment for vulnerable populations.

Interestingly, the specific types or amounts of activities (functional, pleasurable, or social) did not significantly correlate with symptom improvement, suggesting that simply engaging in activities to counter avoidance may be key to the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. Hershenberg, R., Paulson, D., Gros, DF., et al.[2015]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/search/CJ-gPB-Ng0aOmrYdfJc6qw/project-details/10977067

RePORT RePORTER - National Institutes of Health (NIH) | Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline. Project Number ...

2. trialx.com trialx.com/clinical-trials/listings/302247/behavioral-activation-for-independence-in-older-veterans/

Behavioral Activation for Independence in Older Veterans The overarching goal of this study is to develop and test the feasibility and acceptability of a telehealth-delivered behavioral activation (BA) intervention ( ...

3. clinicaltrial.be clinicaltrial.be/en/details/15559?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Behavioral Activation for Independence in Older Veterans... Exploratory outcomes include objective physical and cognitive function, quality of life, mood, behavioral activation, social isolation, and ...

4. withpower.com withpower.com/trial/phase-functional-independence-7-2023-9c15c

Behavioral Activation for Functional Independence in Older ... Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its ...

5. research.va.gov research.va.gov/about/funded_research/proj-details-FY2024.cfm?pid=748306

Development and Feasibility of a Behavioral Activation ... Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline. Principal ...

6. ctv.veeva.com ctv.veeva.com/study/behavioral-activation-for-independence-in-older-veterans

Behavioral Activation for Independence in Older Veterans The overarching goal of this study is to develop and test the feasibility and acceptability of a telehealth-delivered behavioral activation (BA) ...

7. database.clin-star.org database.clin-star.org/display/project-5IK2RX00393003

Development and Feasibility of a Behavioral Activation ... This project will adapt an empirically-supported psychosocial therapy for depression – behavioral activation (BA) – to promote physical, cognitive, and social ...