Clinical trial Recruiting at 1 site Interventional Ages 18 and up

VOCALE LBD: Online Support for Caregivers of Lewy Body Dementia

Official title: Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.

Run by University of Washington · NCT07637097 · Data updated 2026-11-12

This online, text-based program tests whether a tailored 8-week caregiver group helps reduce depression in family caregivers of people with Lewy Body Dementia compared with standard educational materials.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment220 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedDecember 1, 2026
Main results expectedNovember 30, 2029
Study endsNovember 30, 2030
Registry record updatedNovember 4, 2026
Trial IDNCT07637097 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are unpaid family or informal caregivers of someone with Lewy Body Dementia who have depressive symptoms (PHQ-9 ≥ 5), are English-speaking, and have internet access (or can use a loaner device).

Probably not a fit

Caregivers without depressive symptoms, non-English speakers, paid/professional caregivers, or those unable to access an internet-connected device may derive less or no direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

VOCALE LBD is an 8-week, fully asynchronous online group intervention for unpaid family caregivers of people with Lewy Body Dementia. Groups of 10–15 caregivers participate in moderated discussions using a text-based platform, with weekly topics focused on LBD-specific challenges and problem-solving skills. The program is delivered via Discourse and requires no video conferencing, with loaner devices and digital literacy support available. A prior pilot showed strong reductions in depressive symptoms, and this trial compares VOCALE LBD to standard educational materials to determine its effect on caregiver depression and well-being.

Why it matters

Potential benefit: If successful, the program could meaningfully reduce depressive symptoms among LBD caregivers and provide scalable, accessible support.

How similar studies have gone: Previous pilot work in VOCALE LBD reported strong reductions in depressive symptoms, suggesting potential benefit, though this exact format is novel for LBD caregivers.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

  • University of Washington
    Seattle, Washington, United States
    Recruiting

Study contacts

  • Principal investigator: Oleg Zaslavsky, PhD, RN — University of Washington, School of Nursing
  • Study coordinator: Aimy Paulsen, MPH
  • Email: vocale-lbd@uw.edu
  • Phone: (253) 693-8329

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.