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CompletedNCT05243264

Empower@Home: A Feasibility Pilot

Empower@Home: A Feasibility Study of a Novel Internet-based Cognitive Behavioral Therapy Program for Depression Among Homebound Older Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. 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.

Detailed description

Depression affects up to 40% of homebound seniors. The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. Our team developed Empower@Home collaboratively with older adult stakeholders and social service providers. It is the first iCBT program tailored for low-income racially diverse homebound seniors. It has the potential to reduce access barriers to mental health services among this high-need population. Although Empower@Home is based on an evidence-based mental health treatment (i.e., CBT), it is a novel intervention and has not yet been tested with human subjects. This is a pilot study that involves testing the feasibility, acceptability, and preliminary effects of the intervention with a single group of participants in an open trial. No randomization will occur. All eligible participants who consent will receive the intervention. A total of15 older adults will be recruited to participate in this study. All of them will be recruited through referrals from 2 to 3 social service agencies on this list (The Information Center, Region 2 Area Agency on Aging (AAA), Senior Resources, and A \& D home care). The intervention involves attending up to 10 pre-recorded online therapy sessions and receiving weekly maintenance calls from trained research assistants for up to 12 weeks. Participants will engage in therapy at their private homes. A comprehensive baseline and post-test will be administered either over the phone or via an online survey, depending on the participants' preference. No in-person interaction between the participants and the research team is anticipated during the active treatment phase unless intervention is warranted for subjects' safety. Quantitative and qualitative data will be collected and analyzed.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEmpower@HomeThe intervention is a 10-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive a weekly check-in call to see how they are doing. The weekly check-in call is intended to be brief and last no more than 10 minutes on average.

Timeline

Start date
2022-02-28
Primary completion
2022-07-30
Completion
2022-08-30
First posted
2022-02-17
Last updated
2022-09-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05243264. Inclusion in this directory is not an endorsement.