NCT07637097Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- University of Washington
- Diseases
- Lewy body dementia
- NCT number
- NCT07637097
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Dec 2026 to the primary completion date, 30 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Active suicidal ideation as indicated by endorsement of PHQ-9 Item 9 (thoughts that you would be better off dead, or thoughts of hurting yourself)
- Paid or professional caregiver (must be unpaid family/informal caregiver)
- Unable to read, write, or speak English
Who the study is looking for
- Current family member or informal (unpaid) caregiver of a person with a confirmed diagnosis of Lewy Body Dementia (LBD) or LBD mixed pathology
- Experiences depressive symptoms as defined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)
- Able to read, write, and speak English
- Has access to a device (computer, tablet, or smartphone) that can connect to the internet and be used for videoconferencing or phone calls, OR is interested in using a loaner device
- Has an active email address OR is willing to create and use an email address prior to enrollment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.