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

NCT04915040 | Completed

• 1 other identifier: HSC-SPH-21-0272
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

social support; dementia; caregivers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Behavioral Activation for Depression

EXPERIMENTAL

Behavioral: Behavioral Activation for Depression

Interventions

Behavioral Activation for Depression BEHAVIORAL

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

Behavioral Activation for Depression

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of suicidal ideation with clear intent,
• concurrent enrollment in another clinical trial for depression,
• substance use disorder.
• Active psychosis or significant dementia at screening;
• presence of suicidal ideation with clear intent.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depression; Dementia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: July 1, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)