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

Trial Summary

What is the purpose of this trial?

As Veterans age, chronic health conditions increase their risk of functional limitations, or difficulty completing day-to-day activities independently. Older adults with functional limitations are more likely to be hospitalized or admitted to long-term care facilities. Maintaining independence at home and in the community is a high priority for many older Veterans. The goal of this study is to support the physical, cognitive, and social functioning of older Veterans by developing a program based on behavioral activation, an evidence-based brief psychosocial intervention that helps individuals increase their engagement in activities aligned with their values (i.e. what matters most to them). The study consists of 3 aims. Aim 1 involves adapting an existing behavioral activation program for older Veterans at risk for functional decline to be delivered by video telehealth and seeking feedback from Veterans and VA staff about the program materials. Aim 2 involves testing the program in a group of 10 Veterans to learn whether it is satisfactory to Veterans; the investigators will make improvements to the program based on the information gathered in this aim. Aim 3 is a randomized controlled trial that will test the behavioral activation program compared to usual care in older adulthood in 48 Veterans. This will help determine whether the program is possible to deliver as planned and acceptable to Veterans, and assess the potential effects of the program on functioning and related health outcomes.

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 data supports the effectiveness of the treatment Behavioral Activation for Independence in Older Veterans (ACTIVaTE)?

Research shows that Behavioral Activation (BA) is effective in reducing depression symptoms in older adults, even those with mild to moderate cognitive impairment. It involves activities that increase positive interactions with the environment, which can help improve mood and function. ^{1 2 3 4 5}

How is the treatment Behavioral Activation for Independence in Older Veterans (ACTIVaTE) different from other treatments for older veterans?

ACTIVaTE is unique because it focuses on increasing engagement in meaningful activities to improve independence and mental health in older veterans, rather than relying on medication. This approach is based on Behavioral Activation, which has been effective in treating depression by encouraging patients to participate in activities that bring them pleasure or a sense of accomplishment. ^{1 2 3 6 7}

Research Team

Meaghan A Kennedy, MD MPH

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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 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]

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]

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]

References

1. United States 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. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The effects of behavioral activation therapy with inpatient geriatric psychiatry patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]