DepressionNCT06721559
Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
A study testing Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression and Telephone friendly visits in people with Depression, run by University of Michigan at 1 site in United States.
Trial summary
This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression and Telephone friendly visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to Dec 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) be receiving or eligible to receive services at the recruitment sites
- (2) read and speak English
- (3) be at least 50 years old
- (4) have at least mild depressive symptoms at screening (≥ 5 on the Patient Health Questionnaire-9 [PHQ-9]).
- (5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation.
- (6) have mobility limitations based on self-reported limitations in 10 mobility related questions (e.g., difficulty climbing stairs or walking)
Who cannot join
- (1) probable dementia based on the Blessed Orientation and Memory Scale.
- (2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale
- (3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report
- (4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review
- (5) severe vision impairment based on self-report (i.e., legally blind)
- (6) current substance use disorders or receiving substance use treatment.
- (7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 3 months ago
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
University of Michigan
Ann Arbor, Michigan, 48109
Xiaoling Xiang, PhD, 734-215-5772, xiangxi@umich.edu
Xiaoling Xiang, PhD
About this study
This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory disabilities. A total of 64 participants with ambulatory disabilities will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio.
This project addresses the following research questions:
- Does the intervention affect individuals' lives in the following expected areas?
- Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
- Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
- Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)?
- How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?
Read the detailed description
This study is a randomized Type I hybrid effectiveness-implementation trial designed to evaluate the clinical effectiveness and implementation process of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program tailored for homebound older adults with depressive symptoms. The trial compares Empower@Home, supported by aging service providers, to an enhanced usual care condition. The study involves 64 participants with ambulatory disabilities who will be randomly assigned to either the treatment or control group.
Rationale: Depression is a significant public health concern among homebound older adults, with approximately 50% experiencing clinically significant depressive symptoms and 14% facing major depression-rates significantly higher than those of non-homebound counterparts. Homebound older adults often encounter barriers to accessing traditional mental health services, including physical disabilities, socioeconomic disadvantages, and racial or ethnic minority status. Empower@Home addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions (DMHIs).
Intervention: Empower@Home is a nine-session, computerized CBT program enhanced with entertainment elements to increase engagement. The program is specifically designed for homebound older adults, incorporating age-relevant examples and a simplified user interface. It includes features such as a character-driven storyline, short videos, and interactive exercises to facilitate learning and engagement. The program is supported by lay coaches-aging service providers trained to offer weekly support calls, enhancing program adherence and personalization.
This project addresses the following research questions:
- Does the intervention affect individuals' lives in the following expected areas?
- Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
- Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
- Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)?
- How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?
Study Design: Participants will be recruited from an aging service agencies that serve as implementation sites. Participants will undergo remote assessments via phone at baseline, post-intervention, and a follow-up at 24 weeks.
Expected Outcomes: The study is expected to demonstrate that Empower@Home, when supported by aging service providers, is more effective than usual care and friendly calls in reducing depressive symptoms and improving social engagement and activities participation. Additionally, the findings will provide valuable insights into the barriers and facilitators to implementing DMHIs in community settings, offering guidance for future scalability and sustainability of such interventions.
Innovation: Empower@Home integrates user-centered design principles, community participatory research, and innovative engagement strategies, such as character-driven storytelling, to enhance user experience and therapeutic outcomes. The use of aging service providers as lay coaches not only addresses the shortage of mental health professionals but also aligns with the existing infrastructure of aging services, making the program highly scalable and sustainable.
This trial will contribute significantly to the growing body of evidence on the effectiveness of DMHIs in real-world settings and inform strategies for broader implementation within community-based aging and disability services.
- Conditions
- Depression
- Being tested
- Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression, Telephone friendly visits
- Keywords
- Cognitive behavioral therapy, Older adults, Internet-based intervention, Depression, Social isolation
- Medical subject headings
- Depression, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depressionBehavioural
Empower@Home is an online self-help intervention based on cognitive behavioral therapy principles designed to treat depressive symptoms in older adults. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. The online sessions contain entertainment elements in the form of a character-driven story of a homebound older adults, video-based psycho-educational content, voice-over instructions, interactive exercises, and weekly home practice assignments.
Telephone friendly visitsOther
Participants in the waitlist control group will receive attention control through biweekly telephone-friendly visitors. Trained project staff will call participants to provide companionship, emotional support, and a friendly conversation. In addition, the callers will conduct a biweekly assessment of depressive symptoms using the patient health questionnaire (PHQ-9), to mirror the biweekly in-app PHQ-9 assessments with the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Empower@Home supported by aging service providers | Experimental | Participants will be provided with access to a 9-session online program called Empower@Home, a self-help intervention based on cognitive behavioral therapy principles. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. Participants will have up to 12 weeks to try to complete the program with the support of a trained coach. Receives: Behavioral: Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression |
| Attention call with friendly visitors | Other | Participants will receive enhanced care as usual, including care as usual from their social service provider and a psycho-educational handout. In addition, they will receive telephone friendly calls from a research staff every other week to mimic the human interactions provided by coaches in the experimental group. Receives: Other: Telephone friendly visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.
Measured: Change from Baseline to follow-up assessments at 12 and 24 weeks
Change in Social Engagement and Activities Questionnaire (SEAQ)
Change in 10 item standardized measures of participation in social activities and community participation. The total scores range from 0 to 50, and a higher score suggesting a higher level of participation.
Measured: Change from Baseline to follow-up assessments at 12 and 24 weeks
Secondary outcomes (1)
Change in Duke Social Support Index (DSSI)-10
Change in 10 item standardized measure for social interaction and satisfaction with social support. Total score ranges from 10 to 30, higher score means higher social support.
Measured: Change from Baseline to follow-up assessments at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start8 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Xiang, University of Michigan
- Investigators
- Xiaoling Xiang, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721559
- Sponsor's protocol ID
- HUM00259594
- Other IDs
- 90IFRE0097
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared through ICPSR, in compliance with NIDILRR funding requirements. The data will be available to qualified researchers following appropriate data use agreements. All quantitatively collected, non-identifying IPD, along with data dictionaries will be deposited to ICPSR.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower@Home: Community Implementation for Older Adults With Ambulatory Disabilities
- ClinicalTrials.gov ID
- NCT06721559
- Acronym / sponsor ID
- HUM00259594
- Conditions
- Depression
- Keywords
- Cognitive behavioral therapy, Older adults, Internet-based intervention, Depression, Social isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory disabilities. A total of 64 participants with ambulatory disabilities will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio.
This project addresses the following research questions:
- Does the intervention affect individuals' lives in the following expected areas?
- Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
- Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
- Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)?
- How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?
Detailed description
This study is a randomized Type I hybrid effectiveness-implementation trial designed to evaluate the clinical effectiveness and implementation process of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program tailored for homebound older adults with depressive symptoms. The trial compares Empower@Home, supported by aging service providers, to an enhanced usual care condition. The study involves 64 participants with ambulatory disabilities who will be randomly assigned to either the treatment or control group.
Rationale: Depression is a significant public health concern among homebound older adults, with approximately 50% experiencing clinically significant depressive symptoms and 14% facing major depression-rates significantly higher than those of non-homebound counterparts. Homebound older adults often encounter barriers to accessing traditional mental health services, including physical disabilities, socioeconomic disadvantages, and racial or ethnic minority status. Empower@Home addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions (DMHIs).
Intervention: Empower@Home is a nine-session, computerized CBT program enhanced with entertainment elements to increase engagement. The program is specifically designed for homebound older adults, incorporating age-relevant examples and a simplified user interface. It includes features such as a character-driven storyline, short videos, and interactive exercises to facilitate learning and engagement. The program is supported by lay coaches-aging service providers trained to offer weekly support calls, enhancing program adherence and personalization.
This project addresses the following research questions:
- Does the intervention affect individuals' lives in the following expected areas?
- Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual?
- Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual?
- Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)?
- How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?
Study Design: Participants will be recruited from an aging service agencies that serve as implementation sites. Participants will undergo remote assessments via phone at baseline, post-intervention, and a follow-up at 24 weeks.
Expected Outcomes: The study is expected to demonstrate that Empower@Home, when supported by aging service providers, is more effective than usual care and friendly calls in reducing depressive symptoms and improving social engagement and activities participation. Additionally, the findings will provide valuable insights into the barriers and facilitators to implementing DMHIs in community settings, offering guidance for future scalability and sustainability of such interventions.
Innovation: Empower@Home integrates user-centered design principles, community participatory research, and innovative engagement strategies, such as character-driven storytelling, to enhance user experience and therapeutic outcomes. The use of aging service providers as lay coaches not only addresses the shortage of mental health professionals but also aligns with the existing infrastructure of aging services, making the program highly scalable and sustainable.
This trial will contribute significantly to the growing body of evidence on the effectiveness of DMHIs in real-world settings and inform strategies for broader implementation within community-based aging and disability services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empower@Home supported by aging service providers | Experimental | Behavioral: Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depressionParticipants will be provided with access to a 9-session online program called Empower@Home, a self-help intervention based on cognitive behavioral therapy principles. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. Participants will have up to 12 weeks to try to complete the program with the support of a trained coach. |
| Attention call with friendly visitors | Other | Other: Telephone friendly visitsParticipants will receive enhanced care as usual, including care as usual from their social service provider and a psycho-educational handout. In addition, they will receive telephone friendly calls from a research staff every other week to mimic the human interactions provided by coaches in the experimental group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) be receiving or eligible to receive services at the recruitment sites
- (2) read and speak English
- (3) be at least 50 years old
- (4) have at least mild depressive symptoms at screening (≥ 5 on the Patient Health Questionnaire-9 [PHQ-9]).
- (5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation.
Key exclusion criteria (7 listed)
- (1) probable dementia based on the Blessed Orientation and Memory Scale.
- (2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale
- (3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report
- (4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review
- (5) severe vision impairment based on self-report (i.e., legally blind)
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 |
|---|---|---|
| Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depressionEmpower@Home is an online self-help intervention based on cognitive behavioral therapy principles designed to treat depressive symptoms in older adults. The intervention has three components: 9 interactive self-paced online sessions, printed workbook that goes along the online sessions for exercises and homework, and telephone coaching by a trained staff from a social service agency serving older adults. The online sessions contain entertainment elements in the form of a character-driven story of a homebound older adults, video-based psycho-educational content, voice-over instructions, interactive exercises, and weekly home practice assignments. | Behavioural | Empower@Home supported by aging service providers |
| Telephone friendly visitsParticipants in the waitlist control group will receive attention control through biweekly telephone-friendly visitors. Trained project staff will call participants to provide companionship, emotional support, and a friendly conversation. In addition, the callers will conduct a biweekly assessment of depressive symptoms using the patient health questionnaire (PHQ-9), to mirror the biweekly in-app PHQ-9 assessments with the experimental group. | Other | Attention call with friendly visitors |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from Baseline to follow-up assessments at 12 and 24 weeks
Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.
Change in Social Engagement and Activities Questionnaire (SEAQ)
Time frame: Change from Baseline to follow-up assessments at 12 and 24 weeks
Change in 10 item standardized measures of participation in social activities and community participation. The total scores range from 0 to 50, and a higher score suggesting a higher level of participation.
1 secondary outcome
Change in Duke Social Support Index (DSSI)-10
Time frame: Change from Baseline to follow-up assessments at 12 and 24 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 21 Nov 2025.
- Intervention websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared through ICPSR, in compliance with NIDILRR funding requirements. The data will be available to qualified researchers following appropriate data use agreements. All quantitatively collected, non-identifying IPD, along with data dictionaries will be deposited to ICPSR.
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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.
Xiaoling Xiang, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression and Telephone friendly visits in people with Depression, run by University of Michigan 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 6 inclusion and 7 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 21 Nov 2025. 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 Xiaoling Xiang, PHD (734-763-6581, xiangxi@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Change from Baseline to follow-up assessments at 12 and 24 weeks). The study lists 2 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 21 Nov 2025.