Behavioral Activation for Independence in Older Veterans

Part of paid clinical trials in Bedford, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT05493241
Status
Recruiting

Conditions

  • Functional Independence

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Activation for Independence in Older Veterans (ACTIVaTE) — BEHAVIORAL
    6 sessions delivered by a psychology trainee by telehealth will cover the core content of an existing BA model, Brief Behavioral Activation for Depression-Revised (BATD-R), including education on BA and rationale for the intervention, activity monitoring, values exploration, and activity selection and planning. ACTIVaTE will include the following key modifications: 1) modifying background and psychoeducation to focus on maintaining functional independence; 2) tailoring content to Veterans; 3) adapting materials for VVC telehealth delivery; 4) incorporating elements of activity and environmental modification from an OT perspective; and 5) adding content on VA and community resources for older Veterans. Each session is structured similarly, consisting of education or review of concepts, review of homework and troubleshooting challenges, discussion of core content (e.g. values exploration or activity planning/scheduling), and assignment of homework for the next session.
  • Usual care — OTHER
    In this study, both arms will have access to usual care as part of their routine clinical care. Recognizing the heterogeneity of primary care services provided to patients at risk for functional decline, we will minimally standardize the usual care arm by providing a booklet of educational information on maintaining activity to support independence in aging (e.g., an NIH handout "Participating in Activities you Enjoy as you Age" and information on VA and community recreation programs to stay active) that will be mailed to participants after randomization.

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Open trial
    In Aim 2, all 10 participants will receive the ACTIVaTE intervention.
  • Experimental: ACTIVaTE intervention
    In Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention.
  • Other: Usual care
    In Aim 3, 24 participants will be randomized to a usual care arm.

Primary Outcome Measure

Enrollment [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Bedford HealthCare System, Bedford, MABedfordMassachusetts01730-1114
Meaghan A Kennedy, MD MPH
412-688-6000
Meaghan A Kennedy, MD MPH (PRINCIPAL_INVESTIGATOR)

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