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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregiver Burden; Caregivers; Lewy Bodies Disease; Depression Disorder
• Intervention / Treatment: Behavioral: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia; Other: Standard of Care Educational Materials

Detailed Description

Over 1.4 million people in the U.S. are diagnosed with Lewy Body Dementia (LBD). Up to 80% receive care from family members, yet family caregivers of people with LBD experience depression at rates (40-50%) double those of Alzheimer's disease caregivers. LBD's distinct features - visual hallucinations, REM sleep behavior disorder, cognitive fluctuations, and Parkinsonian motor symptoms - create caregiving demands not addressed by existing dementia caregiver interventions. Current pharmacological treatments for LBD are largely experimental, leaving families to manage severe behavioral and motor symptoms without adequate support. INTERVENTION: VOCALE LBD (Virtual Online Communities for Aging Life Experiences - Lewy Body Dementia) is a fully asynchronous, text-based online group intervention delivered via the Discourse platform. The 8-week program includes icebreaker activities followed by LBD-specific weekly topics (self-care, sleep problems, hallucinations and delusions) and problem-solving training using the ADAPT method (Adopting a positive attitude, Defining the problem, brainstorming Alternatives, Predicting consequences, Trying the solution). Groups of 10-15 caregivers are moderated by a licensed nurse or social worker (RN/LCSW), who logs in daily and facilitates discussions. The platform requires no video conferencing and is accessible via any internet-connected device. Loaner devices and digital literacy training are provided for participants who need them. STUDY DESIGN: Two-arm, randomized controlled trial. Participants are randomized 1:1 to (a) VOCALE LBD or (b) Standard of Care (SOC: NIA psychoeducational materials, LBDA resource list, problem-solving handouts). Assessment time points: baseline, post-intervention (week 8), and 6-month follow-up. Exit interviews are conducted at the end of the intervention. AIMS: Aim 1 tests whether VOCALE LBD reduces depressive symptoms (CES-D) compared to SOC at week 8, with sustained effect at 6 months. Aim 2 examines mechanisms - whether self-efficacy and problem-solving mediate outcomes (2a quantitative mediation; 2b qualitative analysis). Aim 3 explores pragmatic monitoring using user engagement analytics, natural language processing, and LLM-assisted moderator support tools. RECRUITMENT: Nationwide recruitment through the Lewy Body Dementia Association (LBDA) via eblasts, social media, support groups, and print materials. Additional outreach via Alzheimer.gov and national LBD caregiver web resources.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oleg Zaslavsky, PhD, RN; Phone Number: (206) 849-3301; Email: zaslav@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
      • Contact: Oleg Zaslavsky, PhD, RN; Phone Number: (206) 849-3301; Email: zaslav@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOCALE LBD; Participants 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.	Behavioral: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia; 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).; Other Names: VOCALE LBD; Virtual Online Community; Asynchronous Online Group Intervention
Active Comparator: Standard of Care; 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.	Other: Standard of Care Educational Materials; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress (PSS)	10-item scale measuring perceived stress in the past month. Higher scores = greater stress	Baseline, Week 8, 6-month Follow-up
Social Support (MOS)	Medical Outcomes Study (MOS) Social Support Scale: measures emotional, tangible, affectionate, and positive social interaction. Higher scores = greater support.	Baseline, Week 8, 6-month follow-up
Caregiving Burden	Short Zarit Caregiver Burden Interview: 12-item measure of caregiver burden covering personal strain and role strain. Higher scores = greater burden.	Baseline, Week 8, 6 month follow-up
Loneliness	UCLA Loneliness Scale: measures subjective feelings of loneliness and social isolation. Higher scores = greater loneliness	Baseline, Week 8, 6 month follow-up
Platform Engagement	Platform Engagement (UES) User Engagement Scale (UES): characterizes quality of users' interactions with the Discourse platform (focused attention, perceived usability, aesthetics, reward). Post-Intervention (Week 8)	Post Intervention (week 8)
Problem Solving	Social Problem Solving Inventory - Revised (SPSI-R): assesses problem-solving orientation and style. Used as mechanistic measure (Aim 2a).	Baseline, Week 4, Week 8, 6-month followup
Health Self-Efficacy	Health Self-Efficacy 5-item Health Self-Efficacy Measure: assesses confidence in managing health-related tasks. Used as mechanistic measure (Aim 2a).	Baseline, Week 4, Week 8, 6-month follow-up
Sustained Effect on Depression (CES-D)	CES-D at 6-month follow-up: tests sustained (durable) reduction in depressive symptoms beyond the active intervention period.	6-Month Follow-up

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH); National Institute on Aging (NIA); The Lewy Body Dementia Association (LBDA)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Telehealth; Digital Health; Online Intervention; Family caregivers; Lewy body disease; Peer Support; Asynchronous; LBD; Dementia caregiver; Problem-solving therapy; Caregiver Depression; VOCALE; ADAPT method; Discourse Platform
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Stress, Psychological; Parkinsonian Disorders; Basal Ganglia Diseases; Behavior; Caregiver Burden; Lewy Body Disease
• Other Study ID Numbers: A214588; 1R01MH139601-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months after publication of primary outcome results; available for 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No