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

November 29, 2023 updated by: Michael Bradley Cannell, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Activation for Depression
Behavioral: Behavioral Activation for Depression
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment as assessed by number of participants enrolled in the study
Time Frame: Week 0
Week 0
Feasibility of retention as assessed by number of participants who complete at least 6 sessions
Time Frame: Week 8
Week 8
Feasibility of data collection as assessed by percent of missing data
Time Frame: Week 8
Week 8
Change in Depression as measured by the Geriatric Depression Scale
Time Frame: 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.
Week 0, Week 4, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-21-0272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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