Depression Clinical Trial
Official title:
Empower@Home: A Feasibility Study of a Novel Internet-based Cognitive Behavioral Therapy Program for Depression Among Homebound Older Adults
Verified date | September 2022 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 30, 2022 |
Est. primary completion date | July 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. =60 years 2. have at least mild depressive symptoms, based on PHQ-9 >=5 3. are willing to participate Exclusion Criteria: 1. Currently receiving CBT or iCBT 2. Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >= 10). 3. They do not speak English 4. have active suicidal ideation (any positive response on the 9th item of PHQ-9) 5. Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months 6. Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Patient Health Questionnaire-9 (PHQ-9) | Change in 9 item standardized measures of depressive symptom severity | Change from Baseline PHQ-9 at 12 weeks | |
Primary | Modified Treatment Evaluation Inventory | 11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context | 12 weeks | |
Secondary | Change in Generalized Anxiety Disorder Assessment-7 (GAD-7) | Change in 7-item standardized measure for severity of anxiety symptoms | Change from Baseline at 12 weeks | |
Secondary | Change in Duke Social Support Index (DSSI)-10 | Change in 10 item standardized measure for social interaction and satisfaction with social support | Change from Baseline at 12 weeks | |
Secondary | Change in PROMISE-SI | Change in 8 item standardized measure for feelings of loneliness | Change from Baseline at 12 weeks |
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