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OpenTrials
Completed

NCT Number: NCT04915040

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Activation for Depression

Behavioral

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 outcomes

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

    Time frame: Week 0

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

    Time frame: Week 8

  3. Feasibility of data collection as assessed by percent of missing data

    Time frame: Week 8

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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