Recruiting

Behavioral Activation

Sponsor:

VA Office of Research and Development

Code:

NCT05493241

Conditions

Functional Independence

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Behavioral Activation for Independence in Older Veterans (ACTIVaTE)

Usual care

Study Details

Brief summary:

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.

Conditions

Functional Independence

Study ID

NCT05493241

Start date

Feb 12, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Behavioral Activation for Independence in Older Veterans (ACTIVaTE)

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

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.

Primary outcome measure

  • Enrollment [ Time Frame: Baseline ]
  • Retention at 12 weeks [ Time Frame: 12 weeks ]
  • Adherence [ Time Frame: 12 weeks ]
  • Satisfaction at intervention completion [ Time Frame: 6 weeks ]
  • Themes based on Theoretical Framework of Acceptability domains [ Time Frame: 6 weeks ]
  • Satisfaction at study completion [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Meaghan A Kennedy, MD MPH

(412) 688-6000Meaghan.Kennedy@va.gov

Locations

VA Bedford HealthCare System, Bedford, MA

Recruiting

Bedford, Massachusetts, United States, 01730-1114

Contacts

Meaghan A Kennedy, MD MPH

412-688-6000Meaghan.Kennedy@va.gov

Principal Investigator:

Meaghan A Kennedy, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • functional status
  • aged
  • psychosocial intervention
  • Veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-27.