This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 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 refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a larger single group study to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies and 2) advertisements on social media and the program website. 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 40 minutes to complete over the phone or via an online survey, depending on the participants' preference. Subjects will be recruited from agency referrals and advertisements. Between May 2022 and Dec 2023, about 300 subjects will be recruited into a single group study design where all eligible and consented participants will receive the intervention immediately without waiting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
The intervention is a 9-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive weekly support from a trained research staff.
University of Michigan
Ann Arbor, Michigan, United States
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. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.
Time frame: Change from Baseline at 10 weeks
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.
Time frame: Change from Baseline at 10 weeks
Change in PROMISE-SI
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
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