Behavioral Activation for Independence in Older Veterans

Functional Independence Clinical Trial

— ACTIVaTE  

Official title:

Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493241
• Other study ID #: D3930-W
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Meaghan A Kennedy, MD MPH
• Phone: (412) 688-6000
• Email: Meaghan.Kennedy[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 education about staying active 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 an related health outcomes.

Description:

The overarching goal of this study is to develop and test the feasibility and acceptability of a telehealth-delivered behavioral activation (BA) intervention (ACTIVaTE) to promote physical, cognitive, and social functioning in community-dwelling older Veterans at risk for functional decline. This work will provide preliminary data that will inform the design of a future adequately-powered efficacy trial.

This proposal consists of three aims: Aims 1 and 2 are focused on intervention adaptation and refinement of an existing BA model to optimize the acceptability of the ACTIVaTE intervention and study procedures for older Veterans (NIH Stage Model for Behavioral Intervention Development stage IA). Aim 3 is a feasibility pilot RCT of the ACTIVaTE intervention versus attention control (NIH Stage Model stage IB). A focus on Stage I procedures (intervention generation and refinement, including initial feasibility pilot testing) will ensure that the intervention is optimally tailored to the study population and feasible for subsequent stage II-IV efficacy and effectiveness testing. Mixed methods will be used throughout all aims to optimize the intervention for the VA and telehealth delivery, to incorporate Veterans' preference into the intervention and study design, and to understand barriers and facilitators to implementation during the pilot phase.

Aim 1: Adapt BA protocol for ACTIVaTE (Year 1). The investigators will develop ACTIVaTE based on an existing BA model (Behavioral Activation Treatment for Depression-Revised) for delivery to older Veterans at risk for functional decline via the VA's video telehealth platform (VA Video Connect). The previous experience with BA will inform the initial adaptation, incorporating perspectives from primary care, geropsychology, and occupational therapy. The investigators will seek feedback on the preliminary manual and participant workbook via semi-structured interviews with VA psychologists (n=5), occupational therapists (n=5), and Veterans (n=5), using findings from rapid qualitative analysis to further modify the materials. By design, this intervention development aim is hypothesis-generating as opposed to hypothesis-driven, as the investigators will be using qualitative methods to extract themes that will guide intervention adaptation and refine subsequent aims.

Aim 2: Refine the ACTIVaTE intervention (Year 2). Preliminary acceptability of the intervention will be established through a small open trial of the intervention delivered via VVC to 10 older Veterans at risk for functional decline (Vulnerable Elders Survey-13 score 3) recruited from VA primary care. This early acceptability testing will focus on Veteran satisfaction and experience with the intervention and study procedures and will also be used to optimize interventionist training and fidelity assessment. Participants will complete qualitative interviews guided by the Theoretical Framework of Acceptability (TFA) as well as the Client Satisfaction Questionnaire (CSQ) and findings will be used to further refine the intervention materials prior to the pilot RCT. The investigators hypothesize that the intervention will be preliminarily acceptable as determined by high CSQ scores ( 80%) among at least 70% of participants. The investigators also anticipate that themes identified within TFA domains will demonstrate general acceptability with some recommendations to inform refinement.

Aim 3: Determine feasibility, acceptability, and preliminary impact of ACTIVaTE (Years 3-4). The investigators will conduct a 1:1 randomized pilot RCT of ACTIVaTE versus attention control (to control for social interaction and educational aspects of the program) in 48 Veterans at risk for functional decline (VES-13 score 3) recruited from VA primary care. The primary goal of the pilot RCT is to establish feasibility and acceptability, and a fully powered RCT is beyond the scope of this study. However, the investigators will explore preliminary evidence of potential impact on functioning. The investigators will collect clinical measures at baseline, 6 weeks, and 12 weeks, using the Ambulatory Measure for Post-Acute Care (AM-PAC) and PROMIS Satisfaction with Social Roles and Activities as primary measures of physical, cognitive, and social functioning. The investigators will also conduct semi-structured interviews with a purposive sample of participants based on satisfaction and adherence. Exploratory outcomes include objective physical and cognitive function, quality of life, mood, behavioral activation, social isolation, and engagement in physical, cognitive, and social activities.

Aim 3a: Feasibility will be determined by enrollment and retention. Acceptability will be determined by adherence and satisfaction, as well as by themes from qualitative interviews. The investigators hypothesize that the intervention will be feasible (enrollment of 2-3 participants per month for a total n=48; retention of at least 80% of participants at 12 weeks follow-up) and acceptable ( 80% of participants complete at least 5/6 sessions; 70% of participants report high satisfaction on Client Satisfaction Questionnaire).

Aim 3b: Preliminary impact on AM-PAC and PROMIS will be explored through within and between groups mixed-effects linear regression models and proportions of participants who achieve minimal clinically important change in outcomes. The investigators hypothesize that a greater proportion of participants in the ACTIVaTE group will achieve minimal clinically important change in AM-PAC and PROMIS than attention control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Receiving VA primary care

• Community-dwelling (living outside nursing homes)

• At risk for functional decline (VES-13 score 3)

Exclusion Criteria:

• Non-English speaking

• Currently receiving physical therapy, occupational therapy, or psychotherapy

• Advanced cognitive impairment (MIS-T 3)

• 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)

• active suicidal ideation

• likely substance use disorder (positive TICS)

• schizophrenia

• psychosis in the past 6 months

• Lack of capacity provide consent

Related Conditions & MeSH terms

• Functional Independence

Intervention

Behavioral:
• 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.
• Attention control
An attention control (AC) group will be used to control for the social interaction and educational aspects of ACTIVaTE. The AC arm will consist of 6 weekly one-hour VVC-delivered sessions including friendly social conversation plus education on remaining active within the physical, cognitive, and social domains during older adulthood. During each session, the interventionist will review a relevant handout or other educational materials with the participant. AC interventionists will not be trained in the ACTIVaTE intervention, and the investigators will assess whether any key features of ACTIVaTE (activity monitoring/planning, values exploration, problem-solving) are incidentally incorporated into this arm during fidelity assessment.

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical function as measured by the Five Times Sit-to-Stand Test	Time to complete 5 sit-to-stand cycles. This will be used an objective measure of physical function. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in cognitive function as measured by the telephone Montreal Cognitive Assessment (T-MoCA)	T-MoCA is a validated tool for screening for cognitive impairment by telephone with a range of 0-22 and higher scores indicating better functioning. This will be used as an objective measure of cognitive function. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in behavioral activation as measured by the Behavioral Activation for Depression Scale - Short Form (BADS-SF)	BADS-SF is a validated 9-item self-report measure of behavioral activation. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in engagement in physical, cognitive, and social activities as measured by the Community Healthy Activities Model Program for Seniors questionnaire (CHAMPS)	CHAMPS is a validated, 40-item scale assesses self-reported physical activity in older adults. The investigators will divide items into physical, cognitive, and social activity to assess engagement across the three target domains of the ACTIVaTE intervention. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in quality of life as measured by the CDC Health-Related Quality of Life measure (HRQOL-4)	4-item validated measure of health-related quality of life. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)	This 9-item questionnaire is a validated self-report measure of depressive symptoms widely used across settings and populations. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Other	Change in social isolation as measured by the PROMIS Social Isolation Scale (Short Form 4a)	Validated 4-item measure of subjective social isolation. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Primary	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
Primary	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
Primary	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
Primary	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 Aims 2 and 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.	6 weeks
Primary	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
Primary	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	Recruitment	Proportion approached who agree to screening. Recruitment will serve as a measure of feasibility in Aim 3.	Baseline
Secondary	Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales	This standardized measure of physical and cognitive functioning has standardized scores with a mean of 50 and standard deviation of 10; higher scores indicate better functioning. The investigators will measure both change over time and the proportion of participants who achieve clinically meaningful change. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Secondary	Randomization	Proportion eligible who agree to randomization. Randomization will serve as a measure of feasibility in Aim 3.	Baseline
Secondary	Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale	This standardized measure of physical and cognitive functioning has standardized scores with a mean of 50 and standard deviation of 10; higher scores indicate better functioning. The investigators will measure both change over time and the proportion of participants who achieve clinically meaningful change. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Secondary	Fidelity	Mean fidelity score on fidelity checklist. Fidelity will serve as a measure of feasibility in Aim 3 with a benchmark of mean fidelity rating at least 80% on intervention checklist.	12 weeks
Secondary	Change in social functioning as measured by the PROMIS Satisfaction with Social Roles and Activities (Short Form-8a)	Scores are standardized with a mean of 50 and standard deviation of 10; higher scores indicate better functioning. The investigators will measure both change over time and the proportion of participants who achieve clinically meaningful change. Assessed at baseline and 6 weeks in Aim 2 and baseline, 6 weeks, and 12 weeks in Aim 3.	Baseline, 6 weeks, 12 weeks
Secondary	Barriers and facilitators	Themes regarding barriers and facilitators to implementation as determined by participant semi-structured interviews. Barriers and facilitators will serve as a measure of feasibility in Aim 3.	12 weeks
Secondary	Perceived impact and recommendations	Themes regarding perceived impact and recommendations for improvement as determined by participant semi-structured interviews. Perceived impact and recommendations will serve as a measure of acceptability in Aim 3.	12 weeks