Behavioral Activation for Independence in Older Veterans

NCT05493241 | Recruiting

• 1 other identifier: D3930-W
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

functional status; aged; psychosocial intervention; Veterans

Outcome Measures

Primary Outcomes (6)

• Enrollment

  Proportion screened who enroll; number or participants enrolled per month; total number of participants enrolled. Enrollment will serve as a measure of feasibility in Aim 3, with a benchmark of 2-3 Veterans enrolled per month to achieve a sample of 48 participants enrolled over 18 months.

  Baseline

• Retention at 12 weeks

  Proportion enrolled who complete 12wk follow-up. Retention will serve as a measure of feasibility in Aim 3, with a benchmark of at least 80% of participants enrolled completing the 12wk follow-up.

  12 weeks

• Adherence

  Proportion completing at least 5 of 6 sessions. Adherence will serve as a measure of acceptability in Aim 3 with a benchmark of At least 80% of participants completing 5-6 sessions.

  12 weeks

• Satisfaction at intervention completion

  Proportion reporting high satisfaction (at least 80% on the Client Satisfaction Questionnaire \[CSQ-8\]). Satisfaction at intervention completion (6 weeks) will serve as a measure of acceptability in Aim 2 with a benchmark of at least 70% of participants report high satisfaction. Validated measure of treatment satisfaction in mental health and research settings; raw scores will be transformed to a 100-point percentage scale.

  6 weeks

• Themes based on Theoretical Framework of Acceptability domains

  Themes regarding acceptability of the intervention based on the Theoretical Framework of Acceptability as determined by participant semi-structured interviews. This will serve as a measure of acceptability in Aim 2.

  6 weeks

• Satisfaction at study completion

  Proportion reporting high satisfaction (at least 80% on the Client Satisfaction Questionnaire \[CSQ-8\]). Satisfaction at study completion (12 weeks) will serve as a measure of acceptability in Aim 3 with a benchmark of at least 70% of participants report high satisfaction. Validated measure of treatment satisfaction in mental health and research settings; raw scores will be transformed to a 100-point percentage scale.

  12 weeks

Secondary Outcomes (8)

• Recruitment

  Baseline

• Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales

  Baseline, 6-8 weeks, 12 weeks

• Randomization

  Baseline

• Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale

  Baseline, 6-8 weeks, 12 weeks

• Fidelity

  12 weeks

Other Outcomes (10)

• Change in physical function as measured by the Five Times Sit-to-Stand Test

  Baseline, 6 weeks

• Change in cognitive function as measured by the telephone Montreal Cognitive Assessment (T-MoCA)

  Baseline, 6-8 weeks, 12 weeks

• Change in behavioral activation as measured by the Behavioral Activation for Depression Scale - Short Form (BADS-SF)

  Baseline, 6 weeks

Study Arms (3)

Open trial

OTHER

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

Behavioral: Behavioral Activation for Independence in Older Veterans (ACTIVaTE)

ACTIVaTE intervention

EXPERIMENTAL

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

Behavioral: Behavioral Activation for Independence in Older Veterans (ACTIVaTE); Other: Usual care

Usual care

OTHER

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

Other: Usual care

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.

ACTIVaTE intervention; Open trial

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.

ACTIVaTE intervention; Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

RECRUITING

Study Officials

• Meaghan A Kennedy, MD MPH

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meaghan A Kennedy, MD MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In Aim 3, a research coordinator masked to group assignment will conduct the 8- and 12-week assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants in Aim 2 (open trial, single arm) will all receive the ACTIVaTE intervention. Participants in Aim 3 (randomized controlled trial) will be randomly assigned to the ACTIVaTE intervention or usual care.

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 9, 2022
• Study Start: February 12, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)