Clinical Trials Directory

Trials / Completed

CompletedNCT05384704

A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention

Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults

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

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEmpower@HomeThe 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.

Timeline

Start date
2022-05-23
Primary completion
2024-03-30
Completion
2024-03-30
First posted
2022-05-20
Last updated
2024-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05384704. Inclusion in this directory is not an endorsement.