Functional IndependenceACTIVaTENCT05493241
Behavioral Activation for Independence in Older Veterans
A study testing Behavioral Activation for Independence in Older Veterans (ACTIVaTE) in people with Functional Independence, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Independence
- What is being tested?
- Behavioral Activation for Independence in Older Veterans (ACTIVaTE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
Meaghan A Kennedy, MD MPH, 412-688-6000, Meaghan.Kennedy@va.gov
Meaghan A Kennedy, MD MPH
About this study
Official title: Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline
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.
Read the detailed 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 usual care (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 usual care 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, 8 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 usual care.
- Conditions
- Functional Independence
- Being tested
- Behavioral Activation for Independence in Older Veterans (ACTIVaTE), Usual care
- Keywords
- functional status, aged, psychosocial intervention, Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation for Independence in Older Veterans (ACTIVaTE)Behavioural
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 careOther
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 group | Role | What they receive |
|---|---|---|
| Open trial | Other | In Aim 2, all 10 participants will receive the ACTIVaTE intervention. Receives: 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (8)
Recruitment
Proportion approached who agree to screening. Recruitment will serve as a measure of feasibility in Aim 3.
Measured: Baseline
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.
Measured: Baseline, 6-8 weeks, 12 weeks
Randomization
Proportion eligible who agree to randomization. Randomization will serve as a measure of feasibility in Aim 3.
Measured: Baseline
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.
Measured: Baseline, 6-8 weeks, 12 weeks
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.
Measured: 12 weeks
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, 8 weeks, and 12 weeks in Aim 3.
Measured: Baseline, 6-8 weeks, 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start12 Feb 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional IndependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Meaghan A Kennedy, MD MPH, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493241
- Sponsor's protocol ID
- D3930-W
- Acronym
- ACTIVaTE
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Behavioral Activation Intervention to Support Independence in Older Veterans at Risk for Functional Decline
- ClinicalTrials.gov ID
- NCT05493241
- Acronym / sponsor ID
- ACTIVaTE / D3930-W
- Conditions
- Functional Independence
- Keywords
- functional status, aged, psychosocial intervention, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 usual care (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 usual care 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, 8 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 usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open trial | Other | Behavioral: Behavioral Activation for Independence in Older Veterans (ACTIVaTE)In Aim 2, all 10 participants will receive the ACTIVaTE intervention. |
| ACTIVaTE intervention | Experimental | Behavioral: Behavioral Activation for Independence in Older Veterans (ACTIVaTE), Other: Usual careIn Aim 3, 24 participants will be randomized to receive the ACTIVaTE intervention. |
| Usual care | Other | Other: Usual careIn Aim 3, 24 participants will be randomized to a usual care arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACTIVaTE intervention, Open trial |
| Usual careIn 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. | Other | ACTIVaTE intervention, Usual care |
Primary outcome
Enrollment
Time frame: Baseline
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.
Retention at 12 weeks
Time frame: 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.
Adherence
Time frame: 12 weeks
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.
Satisfaction at intervention completion
Time frame: 6 weeks
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.
Themes based on Theoretical Framework of Acceptability domains
Time frame: 6 weeks
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.
Satisfaction at study completion
Time frame: 12 weeks
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.
8 secondary outcomes
Recruitment
Time frame: Baseline
Change in physical functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Daily Activities and Basic Mobility Scales
Time frame: Baseline, 6-8 weeks, 12 weeks
Randomization
Time frame: Baseline
Change in cognitive functioning as measured by the Ambulatory Measure for Post-Acute Care (AM-PAC) Applied Cognitive Scale
Time frame: Baseline, 6-8 weeks, 12 weeks
Fidelity
Time frame: 12 weeks
Change in social functioning as measured by the PROMIS Satisfaction with Social Roles and Activities (Short Form-8a)
Time frame: Baseline, 6-8 weeks, 12 weeks
Barriers and facilitators
Time frame: 12 weeks
Perceived impact and recommendations
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meaghan A Kennedy, MD MPH principal investigator
VA Bedford HealthCare System, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation for Independence in Older Veterans (ACTIVaTE) in people with Functional Independence, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meaghan A Kennedy, MD MPH ((412) 688-6000, Meaghan.Kennedy@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.