- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05732740
Empower@Home:Connected - Feasibility and Preliminary Effect Study
Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jay Kayser, MSW
- Phone Number: 7342155774
- Email: jaykayse@umich.edu
Study Contact Backup
- Name: Xiaolig Xiang, PhD
- Email: xiangxi@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >=60 years
- have at least mild depressive symptoms, based on PHQ-9 >=8
- are willing to participate
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Participants will participant in 9 weekly group-based sessions
|
Cognitive behavioral therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline PHQ9 to post-test at 9 weeks
|
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.
|
Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
|
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.
|
Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Generalized Anxiety Disorder Assessment-7
Time Frame: Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
|
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.
|
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
|
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.
|
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
|
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..
|
Change from baseline PROMIS-Global Health to post-test at 9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jay Kayser, MSW, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00212950-Group
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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