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

Primary Purpose

Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Activation for Depression

About this trial

This is an interventional treatment trial for Depression focused on measuring social support, dementia, caregivers

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Activation for Depression

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of recruitment as assessed by number of participants enrolled in the study

Feasibility of retention as assessed by number of participants who complete at least 6 sessions

Feasibility of data collection as assessed by percent of missing data

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04915040

First Posted

May 31, 2021

Last Updated

May 12, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04915040

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

social support, dementia, caregivers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Behavioral Activation for Depression

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Activation for Depression

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of recruitment as assessed by number of participants enrolled in the study

Time Frame

Week 0

Title

Feasibility of retention as assessed by number of participants who complete at least 6 sessions

Time Frame

Week 8

Title

Feasibility of data collection as assessed by percent of missing data

Time Frame

Week 8

Title

Change in Depression as measured by the Geriatric Depression Scale

Description

15-item self-report for each construct (yes/no) . Score goes from 1 to 15, a higher number indicates presence of depression.

Time Frame

Week 0, Week 4, Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael B Cannell, PhD

Phone

972-546-2925

Michael.B.Cannell@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Melba A Hernandez-Tejada, PhD, DHA

Phone

713-486-2729

Melba.A.HernandezTejada@uth.tmc.edu

Facility Information:

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael B Cannell, PhD

Phone

972-546-2925

Michael.B.Cannell@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Melba A Hernandez-Tejada, PhD, DHA

Phone

7134862729

Melba.A.HernandezTejada@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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