Behavioral Activation for Independence in Older Veterans
ConditionFunctional Independence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Activation for Independence in Older Veterans (ACTIVaTE)
Behavioral6 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 interventionIn 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.
Treatment groups
58 Participants
are divided into 3 treatment groupsGroup A: Open trialOther 1 intervention
Group B: ACTIVaTE interventionExperimental treatment 2 interventions
Group C: Usual careOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
12 weeks3
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.
Time frame
12 weeks4
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.
Time frame
6 weeksSecondary outcomes
1
Recruitment
Proportion approached who agree to screening. Recruitment will serve as a measure of feasibility in Aim 3.
Time frame
Baseline2
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, 8 weeks, and 12 weeks in Aim 3.
Time frame
Baseline, 6-8 weeks, 12 weeks3
Randomization
Proportion eligible who agree to randomization. Randomization will serve as a measure of feasibility in Aim 3.
Time frame
Baseline4
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, 8 weeks, and 12 weeks in Aim 3.
Time frame
Baseline, 6-8 weeks, 12 weeksOther outcomes
1
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.
Time frame
Baseline, 6 weeks2
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, 8 weeks, and 12 weeks in Aim 3.
Time frame
Baseline, 6-8 weeks, 12 weeks3
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.
Time frame
Baseline, 6 weeks4
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, 8 weeks, and 12 weeks in Aim 3.
Time frame
Baseline, 6-8 weeks, 12 weeksSponsors and contacts
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Source ClinicalTrials.gov