CompletedNot Applicable

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

United States7 participantsStarted 2021-07-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Week 0

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

Timeframe: Week 8

Feasibility of data collection as assessed by percent of missing data

Timeframe: Week 8

Change in Depression as measured by the Geriatric Depression Scale

Timeframe: Week 0, Week 4, Week 8

Trial details

NCT IDNCT04915040

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-19

View on ClinicalTrials.gov More Depression trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Week 0

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

Timeframe: Week 8

Feasibility of data collection as assessed by percent of missing data

Timeframe: Week 8

Change in Depression as measured by the Geriatric Depression Scale

Timeframe: Week 0, Week 4, Week 8