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

3 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

220

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Oleg Zaslavsky, PhD, RN
  • Numero di telefono: (206) 849-3301
  • Email: zaslav@uw.edu

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98195
        • University of Washington
        • Contatto:
          • Oleg Zaslavsky, PhD, RN
          • Numero di telefono: (206) 849-3301
          • Email: zaslav@uw.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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).
Altri nomi:
  • VOCALE LBD
  • Virtual Online Community
  • Asynchronous Online Group Intervention
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Perceived stress (PSS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
National Institute on Aging (NIA)
The Lewy Body Dementia Association (LBDA)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

30 novembre 2029

Completamento dello studio (Stimato)

30 novembre 2030

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A214588
  • 1R01MH139601-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Beginning 9 months after publication of primary outcome results; available for 5 years.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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