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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04915040
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Behavioral Activation for Depression	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of recruitment as assessed by number of participants enrolled in the study [Week 0]

2. Feasibility of retention as assessed by number of participants who complete at least 6 sessions [Week 8]

3. Feasibility of data collection as assessed by percent of missing data [Week 8]

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Bradley Cannell, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04915040
• Other Study ID Numbers: HSC-SPH-21-0272
• First Posted: Jun 7, 2021
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Bradley Cannell, Associate Professor, The University of Texas Health Science Center, Houston: social support; dementia; caregivers
• Additional relevant MeSH terms: Dementia; Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 1, 2021