DepressionNCT05732740
Empower@Home:Connected - Feasibility and Preliminary Effect Study
A study testing Empower@Home:Connected in people with Depression and Loneliness, run by University of Michigan at 1 site in United States.
Trial summary
This single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Loneliness, Social Isolation
- What is being tested?
- Empower@Home:Connected
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=60 years
- have at least mild depressive symptoms, based on PHQ-9 >=8
- are willing to participate
Who cannot join
- Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).
- They do not speak English
- have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
- Have severe vision impairment that can not be corrected
- Have probable substance use disorders as assessed by the 4-item CAGE screener (>=2 on the CAGE AND have not been sober for at least one year)
- Have a self-reported psychotic disorder or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.
This single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups.
Read the detailed description
Depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. This study focuses on developing community-based solutions to reduce access barriers. In a previously approved project HUM00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. This study will test an adapted version of Empower@Home called Empower@Home: Connected that is delivered in a group format and also addresses social isolation and loneliness. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.
The intervention involves attending 9 group sessions. The sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. Sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. Participants will complete a comprehensive baseline assessment and post-test. Each assessment will take between 40-60 minutes to complete over the phone. Recruitment will occur between January and April 2023, 20-25 participants will be recruited. All participants will receive the intervention.
- Conditions
- Depression, Loneliness, Social Isolation, Depressive Disorder, Mood Disorders, Mental Disorder
- Being tested
- Empower@Home:Connected
- Medical subject headings
- Depression, Social Isolation, Depressive Disorder, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower@Home:ConnectedBehavioural
Cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will participant in 9 weekly group-based sessions Receives: Behavioral: Empower@Home:Connected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9
Changes in 9-item standardized measure of depression symptom severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more depressive symptoms.
Measured: Change from baseline PHQ9 to post-test at 9 weeks
Changes in De Jong Gierveld Scale
Change in 6-item De Jong Gierveld Short Scale for Emotional and Social Loneliness. Scores range from 0 to 6, with higher scores indicating more loneliness.
Measured: Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.
Changes in 8-item Patient-Reported Outcomes Measurment Information Systems - Social Isolation. PROMIS - SI scores range from 0 to 32, with higher scores indicating higher social isolation.
Measured: Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
Secondary outcomes (3)
Changes in Generalized Anxiety Disorder Assessment-7
Changes in 7-item standardized measure for severity of anxiety symptoms. GAD-7 Scores range from 0 to 21, with higher values indicating higher anxiety.
Measured: Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
Changes in Health Related Quality of Life
Change in 5-item Health-Related Quality of Life. EQ5D-5L Scores range from 0 to 20 with higher scores indicating lower health related quality of life.
Measured: Change from baseline Health-Related Quality of Life to post-test at 9 weeks
Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health
Change in 9-item Patient-Reported Outcomes Measurment Information Systems - Global Health. PROMIS-GH scores range from 9 to 45, with higher scores meaning poorer global health..
Measured: Change from baseline PROMIS-Global Health to post-test at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start17 Jan 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The purpose of this research project is to assess the preliminary effect of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home:Connected. The program is delivered in small groups remotely. It is intended to decrease depression, social isolation, and loneliness in participants by encouraging participants to take part in meaningful and enjoyable activities while challenging problematic thinking patterns.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Xiang, University of Michigan
- Investigators
- Jay Kayser, MSW, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732740
- Sponsor's protocol ID
- HUM00212950-Group
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kayser J, Zheng C, Turner S, Xiang X. Feasibility and Acceptability of a Remote Group Intervention for Depression, Social Isolation, and Loneliness in Older Adults. Clin Gerontol. 2025 Jul-Sep;48(4):757-771. doi: 10.1080/07317115.2024.2440373. Epub 2024 Dec 13.
PubMed 39671245
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.
- ClinicalTrials.gov ID
- NCT05732740
- Acronym / sponsor ID
- HUM00212950-Group
- Conditions
- Depression, Loneliness, Social Isolation, Depressive Disorder, Mood Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 17 Feb 2023 (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 single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups.
Detailed description
Depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. This study focuses on developing community-based solutions to reduce access barriers. In a previously approved project HUM00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. This study will test an adapted version of Empower@Home called Empower@Home: Connected that is delivered in a group format and also addresses social isolation and loneliness. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.
The intervention involves attending 9 group sessions. The sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. Sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. Participants will complete a comprehensive baseline assessment and post-test. Each assessment will take between 40-60 minutes to complete over the phone. Recruitment will occur between January and April 2023, 20-25 participants will be recruited. All participants will receive the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The purpose of this research project is to assess the preliminary effect of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home:Connected. The program is delivered in small groups remotely. It is intended to decrease depression, social isolation, and loneliness in participants by encouraging participants to take part in meaningful and enjoyable activities while challenging problematic thinking patterns.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Empower@Home:ConnectedParticipants will participant in 9 weekly group-based sessions |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=60 years
- have at least mild depressive symptoms, based on PHQ-9 >=8
- are willing to participate
Key exclusion criteria (7 listed)
- Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).
- They do not speak English
- have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
- Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
- Have severe vision impairment that can not be corrected
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:ConnectedCognitive behavioral therapy | Behavioural | Treatment |
Primary outcome
Change in Patient Health Questionnaire-9
Time frame: Change from baseline PHQ9 to post-test at 9 weeks
Changes in 9-item standardized measure of depression symptom severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more depressive symptoms.
Changes in De Jong Gierveld Scale
Time frame: Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
Change in 6-item De Jong Gierveld Short Scale for Emotional and Social Loneliness. Scores range from 0 to 6, with higher scores indicating more loneliness.
Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.
Time frame: Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
Changes in 8-item Patient-Reported Outcomes Measurment Information Systems - Social Isolation. PROMIS - SI scores range from 0 to 32, with higher scores indicating higher social isolation.
3 secondary outcomes
Changes in Generalized Anxiety Disorder Assessment-7
Time frame: Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
Changes in Health Related Quality of Life
Time frame: Change from baseline Health-Related Quality of Life to post-test at 9 weeks
Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health
Time frame: Change from baseline PROMIS-Global Health to post-test at 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 39671245Kayser J, Zheng C, Turner S, Xiang X. Feasibility and Acceptability of a Remote Group Intervention for Depression, Social Isolation, and Loneliness in Older Adults. Clin Gerontol. 2025 Jul-Sep;48(4):757-771. doi: 10.1080/07317115.2024.2440373. Epub 2024 Dec 13.
- 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. This study is not recruiting at the moment.
Jay Kayser, MSW 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:Connected in people with Depression and Loneliness, 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 3 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: finished, as of the sponsor's last update on 2 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (time frame: Change from baseline PHQ9 to post-test at 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05732740, which also lists 1 linked publication.
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 2 Oct 2023.