An interventional study of Empower@Home in Depression, Depressive Disorder and Behavioral Symptoms, 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 2024-06-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.
Depression affects up to 40% of homebound seniors, but most homebound seniors do not receive psychotherapy due to various access barriers. The study team focuses on developing community-based solutions to reduce these access barriers. In a previously approved project HUM00207612, the study team tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The pilot project allowed for refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a pilot randomized control trial to test the effectiveness of Empower@Home with older adults. 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 up to 9 pre-recorded online therapy sessions and receiving weekly coaching calls from trained research assistants for up to 10 weeks. Participants will engage in therapy in their private homes. Three assessments are scheduled, including a comprehensive baseline, a post-test, and a 10-week follow-up. Each assessment takes about 20-40 minutes to complete over the phone.
Between Jan and Sept 2023, about 70 subjects (35 in each group) will be recruited. Participants will be randomized into the treatment group or waitlist control. The treatment group will receive the intervention immediately, whereas the waitlist control will wait for ten weeks before starting the intervention (i.e., after the 10-week "post-test"). Therefore, this is a cross-over design.
Exclusion Criteria:
Behavioral: Empower@Home
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
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.
Time frame: Change from Baseline PHQ-9 at 10 weeks
Modified Treatment Evaluation Inventory
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context. The score ranges from 11 to 55, and a higher score means higher acceptability.
Time frame: 10 weeks
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Change in 7-item standardized measure for severity of anxiety symptoms. GAD-7 score ranges from 0 to 21, higher score means more severe symptoms.
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Time frame: Change from Baseline at 10 weeks
Change in EQ5D-5L
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.
Time frame: Change from Baseline at 10 weeks
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Plan to share: No
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University of Michigan