Behavioral activation program to help older veterans maintain independence
Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline
NA · VA Office of Research and Development · NCT05493241
This study is testing a new online program to help older veterans stay active and independent by improving their physical, mental, and social well-being.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Bedford, Massachusetts) |
| Trial ID | NCT05493241 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a telehealth-delivered behavioral activation intervention called ACTIVaTE, designed to support the physical, cognitive, and social functioning of older Veterans at risk for functional decline. The program will be adapted from an existing model to ensure it meets the specific needs of older Veterans and will involve feedback from participants and VA staff. The study consists of three aims: adapting the intervention, refining it based on feedback, and conducting a feasibility pilot randomized controlled trial comparing the intervention to usual care.
Who should consider this trial
Good fit: Ideal candidates for this study are community-dwelling older Veterans receiving VA primary care who are at risk for functional decline.
Not a fit: Patients who are non-English speaking, currently receiving therapy, or have severe cognitive or health impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could help older Veterans maintain their independence and improve their quality of life.
How similar studies have performed: Other studies have shown success with behavioral activation approaches, making this a promising adaptation for older Veterans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receiving VA primary care * Community-dwelling (living outside nursing homes) * At risk for functional decline (VES-13 score 3 or higher in Aim 2; VA frailty index higher than 0.2 in Aim 3) Exclusion Criteria: * Non-English speaking * Currently receiving physical therapy, occupational therapy, or psychotherapy * Advanced cognitive impairment (MIS-T 3 or lower) * Uncorrectable hearing or visual impairment that would preclude participation * Unstable physical or mental health condition: * ongoing evaluation of new cardiac or respiratory symptoms * receiving hospice or palliative care services * anticipated surgery in the next 3 months * severe depressive symptoms (PHQ-9 14 or higher) * active suicidal ideation * likely substance use disorder (positive TICS) * schizophrenia * psychosis in the past 6 months * (Aim 2 and 3) Currently receiving physical therapy, occupational therapy, or psychotherapy * (Aim 3 only) No access to video-capable device (tablet, smartphone, computer) for VVC visits
Where this trial is running
Bedford, Massachusetts
- VA Bedford HealthCare System, Bedford, MA — Bedford, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Meaghan A Kennedy, MD MPH — VA Bedford HealthCare System, Bedford, MA
- Study coordinator: Meaghan A Kennedy, MD MPH
- Email: Meaghan.Kennedy@va.gov
- Phone: (412) 688-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Independence, functional status, aged, psychosocial intervention, Veterans