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NCT07637097 · ClinicalTrials.gov registry record · NA
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
A NA study, sponsored by University of Washington.
- Not yet
- Registry status
- NA
- Development phase
- 220
- Enrollment target
NCT07637097: Clinical Trial NA study, sponsored by University of Washington.
NCT07637097 is a NA study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 220 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07637097, a NA study, has not yet begun recruiting, sponsored by University of Washington.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 220 participants
- Enrollment target
Study Summary
This study tests whether a tailored, fully asynchronous online group intervention (VOCALE LBD) reduces depression in family caregivers of people with Lewy Body Dementia (LBD), compared to standard educational materials. LBD is the second most common form of degenerative dementia and causes distinct challenges, including visual hallucinations, REM sleep disorder, and severe motor symptoms, that are not addressed by generic caregiver interventions. Depression rates in LBD caregivers reach 40-50%, double the rate seen in Alzheimer's disease caregivers, yet no rigorous digital interventions exist specifically for this population. VOCALE LBD is a text-based, low-bandwidth platform (Discourse) that brings groups of 10-15 caregivers together in an 8-week moderated online community. Weekly topics address LBD-specific challenges (sleep problems, hallucinations, self-care) and problem-solving skills using the ADAPT method. A pilot study (n=54) showed strong effects on depressive symptoms (Cohen's d=0.54 at 1-month follow-up), near-perfect engagement, and high participant satisfaction. This RCT (N=220) will test efficacy, examine mechanisms of action (self-efficacy and problem-solving), and explore analytics approaches for pragmatic monitoring, laying groundwork for future implementation in clinics and community organizations.
Primary Outcome
The CES-D measures the frequency of depressive symptoms in the past week, including negative mood, guilt and worthlessness, and physical symptoms associated with depression. 20-item scale; higher scores indicate greater depressive symptom burden. Validated for use in dementia caregiving populations
Interventions
- BEHAVIORAL VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia
- OTHER Standard of Care Educational Materials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2026-12-01 |
| Est. Completion | 2030-11-30 |
| Phase | NA |
What is known before NCT07637097 opens enrollment
NCT07637097 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia is the first listed.
NCT07637097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07637097 about?
NCT07637097 is a clinical study titled "VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia". This study tests whether a tailored, fully asynchronous online group intervention (VOCALE LBD) reduces depression in family caregivers of people with Lewy Body Dementia (LBD), compared to standard educational materials. LBD is the second most common form of degenerative dementia and causes distinct ...
What is the current status of trial NCT07637097?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 220 participants. The study started on 2026-12-01. Estimated completion is 2030-11-30.
What interventions are being tested in trial NCT07637097?
The interventions under investigation include: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia (BEHAVIORAL), Standard of Care Educational Materials (OTHER).
Who is sponsoring clinical trial NCT07637097?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07637097's enrollment target sits among peer trials
220 481st of 2000 higher than 1,516 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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