VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia
  • Standard of Care Educational Materials

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

The Lewy Body Dementia Association (LBDA)

Collaborator

National Institute on Aging (NIA)

Collaborator

National Institutes of Health (NIH)

Collaborator