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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915040
• Other study ID #: HSC-SPH-21-0272
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment as assessed by number of participants enrolled in the study		Week 0
Primary	Feasibility of retention as assessed by number of participants who complete at least 6 sessions		Week 8
Primary	Feasibility of data collection as assessed by percent of missing data		Week 8
Primary	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