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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04915040
Other study ID # HSC-SPH-21-0272
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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