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

June 3, 2026 updated by: Oleg Zaslavsky, University of Washington

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-Up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived stress (PSS)
Time Frame: Baseline, Week 8, 6-month Follow-up
10-item scale measuring perceived stress in the past month. Higher scores = greater stress
Baseline, Week 8, 6-month Follow-up
Social Support (MOS)
Time Frame: Baseline, Week 8, 6-month follow-up
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
Time Frame: Baseline, Week 8, 6 month follow-up
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
Time Frame: Baseline, Week 8, 6 month follow-up
UCLA Loneliness Scale: measures subjective feelings of loneliness and social isolation. Higher scores = greater loneliness
Baseline, Week 8, 6 month follow-up
Platform Engagement
Time Frame: Post Intervention (week 8)
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
Time Frame: Baseline, Week 4, Week 8, 6-month followup
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
Time Frame: Baseline, Week 4, Week 8, 6-month follow-up
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)
Time Frame: 6-Month Follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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