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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Behavioral Activation for Depression

• Registration Number: NCT04915040
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Study Start: 2021-07-01
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Activation for Depression	Behavioral Activation for Depression	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States