VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
VOCALE LBD
Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.
2 other identifiers
interventional
220
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedStudy Start
First participant enrolled
December 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
Study Completion
Last participant's last visit for all outcomes
November 30, 2030
June 9, 2026
June 1, 2026
3 years
June 3, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D)
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
Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-Up
Secondary Outcomes (8)
Perceived stress (PSS)
Baseline, Week 8, 6-month Follow-up
Social Support (MOS)
Baseline, Week 8, 6-month follow-up
Caregiving Burden
Baseline, Week 8, 6 month follow-up
Loneliness
Baseline, Week 8, 6 month follow-up
Platform Engagement
Post Intervention (week 8)
- +3 more secondary outcomes
Study Arms (2)
VOCALE LBD
EXPERIMENTALParticipants in this arm receive the VOCALE LBD intervention: an 8-week, fully asynchronous, text-based online group program delivered via the Discourse platform. Groups of 10-15 participants are moderated by a licensed nurse or social worker who logs in daily. Weekly discussion topics address LBD-specific caregiving challenges (self-care, sleep problems, hallucinations and delusions) and problem-solving skills training using the ADAPT method. Participants are asked to post at least twice weekly.
Standard of Care
ACTIVE COMPARATORNIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email or mail per participant preference.
Interventions
NIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email or mail per participant preference.
The 8-week VOCALE LBD intervention is delivered asynchronously via the Discourse online platform. The weekly curriculum includes: Pre-intervention (icebreakers, self-introductions); Week 1 (self-care); Week 2 (sleep problems); Week 3 (hallucinations and delusions); Week 4 (problem-solving inventory, SPSI-R); Week 5 (ADAPT - Positive Attitude); Week 6 (ADAPT - Define the Problem); Week 7 (ADAPT - Alternative Solutions); Week 8 (ADAPT - Plan and Try).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- 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
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, University of Washington School of Nursing
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 9, 2026
Study Start (Estimated)
December 1, 2026
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
November 30, 2030
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 9 months after publication of primary outcome results; available for 5 years.
- Access Criteria
- Researchers who provide a methodologically sound data analysis plan. Proposals should be directed to zaslav@uw.edu. To gain access, data requestors will need to sign a data access agreement.
De-identified individual participant data that underlie the results reported in publications (text, tables, figures, appendices) will be shared. Data will be made available 9 months following publication of the primary study results. Data will be deposited in an NIH-designated repository (e.g., NIMH Data Archive or ICPSR). Requests for data should include a data analysis plan and be submitted to the PI.