Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia.

Official Title
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Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Behavioral Activation for Depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant Eligibility Criteria: able to speak and understand English; a diagnosis of mild dementia, as determined by a Clinical Dementia Rating interview Sum of Boxes (CDR-SB) score in the mild range as defined by a score of 4.5 - 9.0; and able to provide informed consent. Caregiver Eligibility Criteria. Beck Depression Inventory (BDI) score below clinical cutoff for depression and able to provide informed consent. Exclusion Criteria: Participant exclusion criteria: presence of suicidal ideation with clear intent, concurrent enrollment in another clinical trial for depression, substance use disorder. Caregiver exclusion criteria: Active psychosis or significant dementia at screening; presence of suicidal ideation with clear intent.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation for Depression<br> | Behavioral: Behavioral Activation for Depression<br>* Behavioral Activation (BA) is an effective treatment for depression, and its components may increase social connection. Generally, caregivers are with the older adult care recipient on a regular basis and may be able, with the correct training, to help enhance certain features of the Behavioral Activation treatment, even under pandemic restrictions on social contact. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based Behavioral Activation + Caregiver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment as assessed by number of participants enrolled in the study |  | Week 0 | 
| Feasibility of retention as assessed by number of participants who complete at least 6 sessions |  | Week 8 | 
| Feasibility of data collection as assessed by percent of missing data |  | Week 8 | 
| Change in Depression as measured by the Geriatric Depression Scale | 15-item self-report for each construct (yes/no) . Score goes from 1 to 15, a higher number indicates presence of depression. | Week 0, Week 4, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social support, dementia, caregivers