Depression Clinical Trial
— Happy@HomeOfficial title:
Happy@Home: Delivering Internet-based Cognitive Behavioral Therapy With Homecare Workers to At-Home Seniors
NCT number | NCT04267289 |
Other study ID # | 2748II |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2019 |
Est. completion date | March 30, 2020 |
Verified date | May 2020 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Depression is one of the most common and debilitating conditions among older adults. At-home seniors, also called homebound seniors, are older adults who are confined to a bed or chair and are unable to get about outdoors. Internet-based CBT (iCBT) delivers CBT via websites or dedicated apps on mobile devices or tablets. iCBT can be self-administered or guided by a therapist. Its strengths include low-cost, accessibility, and ability to tailor to individual needs while maintaining fidelity. Despite its potential, iCBT trials have rarely included older adults. Those that included older adults showed that they tended to report more technological challenges but they benefited from the intervention as much as younger adults did. As far as we know, studies have not yet tested the feasibility and preliminary effects of iCBT with a diverse group of at-home seniors receiving non-skilled home care. This study explores the feasibility and acceptability of delivering iCBT to a sample of at-home seniors who receive non-skilled home care. Home care workers who care for these seniors are recruited to provide assistance for completing iCBT. We hypothesize that iCBT is an acceptable and feasible intervention for treating depression among at-home seniors.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 60 years of age - have received home care for = 1 month and anticipate continued care for = 3 months - have at least mild depressive symptoms (PHQ-9=5) - speak English. Exclusion Criteria: - Currently receiving psychotherapy - Have a psychotic disorder (BPRS) - Have active suicidal ideation based on endorsement of PHQ-9 item 9 (other than not at all) - Severe cognitive impairment, assessed as having = 3 errors on the 6-item Mini mental state exam - Have a planned hospital admission in the next 3 months of enrollment |
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 | Patient Health Questionnaire-9 Items (PHQ-9) | PHQ-9 for depressive symptoms, total score ranges from 0 to 27, higher scores indicate worse depressive symptoms | Change from baseline PHQ9 at end of treatment (3 months after the start of treatment) | |
Primary | # of sessions completed | # of Beating the Blues sessions completed at the end of 3 months | Up to 3 months after the start the treatment | |
Primary | Acceptability | Treatment acceptability scale, has a total of 10 questions, total score ranges from 10 to 50, higher scores indicate higher acceptability | Up to 3 months after the start the treatment | |
Primary | Satisfaction with the treatment program | self rated satisfaction with the program, score ranges from 1 to 10. Higher score indicates higher satisfaction. | Up to 3 months after the start the treatment | |
Secondary | Generalized Anxiety Disorder-7 (GAD-7) | Anxiety symptoms assessment, total score ranges from 0 to 21, higher score indicating worse anxiety symptoms | Change from baseline GAD7 at end of treatment (3 months after the start of treatment) | |
Secondary | Montreal Cognitive Assessment (MoCA) | Cognitive impairment assessment. Total score ranges from 0 to 30. Higher score indicates better cognition and less cognitive impairment. | Change from baseline MoCA at end of treatment (3 months after the start of treatment) | |
Secondary | EQ5D-5L | This measures health related quality of life. EQ5D-5L has five questions and total score is not a simple sum of questions. Scores needs to be converted into utility scores based on population norms. Final utility index score ranges from 0 to 1 (1-sum of raw utility scores), with a higher score indicating better health-related quality of life. | Change from baseline EQ5D at end of treatment (3 months after the start of treatment) |
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