Internet-based cognitive behavioral therapy for depression in older adults
Community-Embedded, Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression: A Type 1 Hybrid Effectiveness- Implementation RCT
This study is testing an online therapy program to see if it can help older adults who are stuck at home and feeling depressed feel better compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06584422 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program, for homebound older adults experiencing depressive symptoms. A total of 256 participants will be randomly assigned to either the Empower@Home program or enhanced usual care, with the aim of assessing improvements in depressive symptoms over 12, 24, and 36 weeks. The study also explores treatment moderators and conducts a cost-effectiveness analysis to determine the economic viability of the intervention. By leveraging aging service providers, the program addresses barriers to accessing traditional mental health services faced by this population.
Who should consider this trial
Good fit: Ideal candidates are homebound older adults aged 50 and above who have moderate depressive symptoms and are eligible for services at the recruitment sites.
Not a fit: Patients with probable dementia, high suicide risk, or severe physical health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mental health outcomes for homebound older adults suffering from depression.
How similar studies have performed: Other studies have shown promise with internet-based CBT interventions for depression, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) be receiving or eligible to receive services at the recruitment sites * (2) read and speak English * (3) be at least 50 years old * (4) have at least moderate depressive symptoms at screening (≥ 8 on the Patient Health Questionnaire-9 \[PHQ-9\]). * (5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation. Exclusion Criteria: * (1) probable dementia based on the Blessed Orientation and Memory Scale. * (2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale * (3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report * (4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review * (5) severe vision impairment based on self-report (i.e., legally blind) * (6) current substance use disorders or receiving substance use treatment. * (7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 3 months ago
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Xiaoling Xiang, PhD — University of Michigan
- Study coordinator: Xiaoling Xiang, PhD
- Email: xiangxi@umich.edu
- Phone: 734-763-6581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.