Lewy Bodies DiseaseVOCALE LBDNCT07637097
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
A study testing VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia in people with Lewy Bodies Disease and Depression Disorder, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lewy Bodies Disease, Depression Disorder, Caregiver Burden
- What is being tested?
- VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Aimy Paulsen, MPH, (253) 693-8329, vocale-lbd@uw.edu
Oleg Zaslavsky, PhD, RN, (206) 849-3301, zaslav@uw.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Lewy Bodies Disease, Depression Disorder, Caregiver Burden, Caregivers
- Being tested
- VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia, Standard of Care Educational Materials
- Keywords
- Lewy body disease, LBD, Family caregivers, Caregiver Depression, Online Intervention, Asynchronous, Digital Health, Peer Support, Problem-solving therapy, VOCALE, Telehealth, Dementia caregiver, ADAPT method, Discourse Platform
- Medical subject headings
- Caregiver Burden, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body DementiaBehavioural
Also called VOCALE LBD, Virtual Online Community, Asynchronous Online Group Intervention
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 (Sleep Problems); Week 2 (Hallucinations and Delusions); Week 3 (ADAPT - Positive Attitude); Week 4 (ADAPT - Define the Problem); Week 5 (ADAPT - Alternative Solutions); Week 6 (ADAPT - Plan); Week 7 (ADAPT - Try); Week 8 (Reflection and Wrap Up).
Standard of Care Educational MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VOCALE LBD | Experimental | 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 facilitated by trained moderators who log in daily. Weekly discussion topics address LBD-specific caregiving challenges (sleep problems, hallucinations and delusions) and problem-solving skills training using the ADAPT method. Participants are asked to make a minimum of three posts each week (e.g., adding a post, replying to two other users). Receives: Behavioral: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia |
| Standard of Care | Active comparator | NIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email. Receives: Other: Standard of Care Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression Scale (CES-D)
A self-report scale that evaluates the frequency of various depressive symptoms experienced in the past week, including negative mood, guilt and worthlessness, and physical symptoms associated with depression
Measured: Baseline (pre-randomization), Post-intervention (Week 8), 6-month follow-up
Secondary outcomes (9)
Short Zarit Caregiver Burden Interview
12-item measure of caregiver burden covering personal strain and role strain. Higher scores = greater burden.
Measured: Baseline, Week 8, 6-month follow-up
UCLA Loneliness Scale
3-item scale that measures subjective feelings of loneliness and social isolation. Higher scores = greater loneliness
Measured: Baseline, Week 8, 6-month follow-up
Perceived Stress Scale (PSS-10)
Measures individuals' perceptions of stress. It assesses how unpredictable, uncontrollable, and overloaded respondents find their lives to be.
Measured: Baseline, Week 8, 6-month follow-up
Social Support Medical Outcomes Study (MOS) Scale
Measures emotional, tangible, affectionate, and positive social interaction. Higher scores = greater support.
Measured: Baseline, Week 5 (mid-intervention), Week 8, 6-month follow-up
Social Problem Solving Inventory-Revised (SPSI-R)
Assesses problem-solving orientation and style. Used as mechanistic measure.
Measured: Baseline, Week 5, Week 8, 6-month follow-up
General Self-Efficacy Scale
10-item scale that assesses confidence in ability to cope with difficult demands and stressful life events.
Measured: Baseline, Week 5, Week 8, 6-month follow-up
Caregiver Self-Efficacy
Caregiver Self-Efficacy Scale, 8-item version (CSES-8). Assesses caregivers' confidence in managing common caregiving challenges.
Measured: Baseline, Week 5, Week 8, 6-month follow-up
User Engagement Scale (UES)
Characterizes quality of users' interactions with the Discourse platform (focused attention, perceived usability, aesthetics, reward).
Measured: Week 8
Benefits of Participating Scale
A study-specific self-report measure designed to assess participants' perceived benefits of participation in the intervention. Higher scores indicate greater perceived positive impact of study participation on caregiving knowledge, confidence, caregiving ability, and daily life.
Measured: Week 8, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Bodies DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Lewy Body Dementia Association (LBDA), National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Oleg Zaslavsky, University of Washington
- Investigators
- Oleg Zaslavsky, PhD, RN, Principal investigator, University of Washington, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637097
- Sponsor's protocol ID
- STUDY00024227
- Other IDs
- 1R01MH139601-01A1
- Acronym
- VOCALE LBD
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.
- ClinicalTrials.gov ID
- NCT07637097
- Acronym / sponsor ID
- VOCALE LBD / STUDY00024227
- Conditions
- Lewy Bodies Disease, Depression Disorder, Caregiver Burden, Caregivers
- Keywords
- Lewy body disease, LBD, Family caregivers, Caregiver Depression, Online Intervention, Asynchronous, Digital Health, Peer Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Lewy Body Dementia Association (LBDA), National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOCALE LBD | Experimental | Behavioral: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body DementiaParticipants 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 facilitated by trained moderators who log in daily. Weekly discussion topics address LBD-specific caregiving challenges (sleep problems, hallucinations and delusions) and problem-solving skills training using the ADAPT method. Participants are asked to make a minimum of three posts each week (e.g., adding a post, replying to two other users). |
| Standard of Care | Active comparator | Other: Standard of Care Educational MaterialsNIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body DementiaAlso: VOCALE LBD, Virtual Online Community, Asynchronous Online Group InterventionThe 8-week VOCALE LBD intervention is delivered asynchronously via the Discourse online platform. The weekly curriculum includes: Pre-intervention (Icebreakers, Self-introductions); Week 1 (Sleep Problems); Week 2 (Hallucinations and Delusions); Week 3 (ADAPT - Positive Attitude); Week 4 (ADAPT - Define the Problem); Week 5 (ADAPT - Alternative Solutions); Week 6 (ADAPT - Plan); Week 7 (ADAPT - Try); Week 8 (Reflection and Wrap Up). | Behavioural | VOCALE LBD |
| Standard of Care Educational MaterialsNIA 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 |
Primary outcome
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline (pre-randomization), Post-intervention (Week 8), 6-month follow-up
A self-report scale that evaluates the frequency of various depressive symptoms experienced in the past week, including negative mood, guilt and worthlessness, and physical symptoms associated with depression
9 secondary outcomes
Short Zarit Caregiver Burden Interview
Time frame: Baseline, Week 8, 6-month follow-up
UCLA Loneliness Scale
Time frame: Baseline, Week 8, 6-month follow-up
Perceived Stress Scale (PSS-10)
Time frame: Baseline, Week 8, 6-month follow-up
Social Support Medical Outcomes Study (MOS) Scale
Time frame: Baseline, Week 5 (mid-intervention), Week 8, 6-month follow-up
Social Problem Solving Inventory-Revised (SPSI-R)
Time frame: Baseline, Week 5, Week 8, 6-month follow-up
General Self-Efficacy Scale
Time frame: Baseline, Week 5, Week 8, 6-month follow-up
Caregiver Self-Efficacy
Time frame: Baseline, Week 5, Week 8, 6-month follow-up
User Engagement Scale (UES)
Time frame: Week 8
Benefits of Participating Scale
Time frame: Week 8, 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleg Zaslavsky, PhD, RN principal investigator
University of Washington, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia in people with Lewy Bodies Disease and Depression Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimy Paulsen, MPH ((253) 693-8329, vocale-lbd@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiologic Studies Depression Scale (CES-D) (time frame: Baseline (pre-randomization), Post-intervention (Week 8), 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.