An interventional study of Empower@Home:Connected in Depression, Loneliness and Social Isolation, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 37 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will participant in 9 weekly group-based sessions
Behavioral: Empower@Home:Connected
Cognitive behavioral therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
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.
Time frame: 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.
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
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..
Time frame: Change from baseline PROMIS-Global Health to post-test at 9 weeks
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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