VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia (VOCALE LBD)
3. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
220
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Oleg Zaslavsky, PhD, RN
- Telefonnummer: (206) 849-3301
- E-Mail: zaslav@uw.edu
Studienorte
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington
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Kontakt:
- Oleg Zaslavsky, PhD, RN
- Telefonnummer: (206) 849-3301
- E-Mail: zaslav@uw.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
|
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).
Andere Namen:
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Aktiver Komparator: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D)
Zeitfenster: Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-Up
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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
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Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-Up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Perceived stress (PSS)
Zeitfenster: Baseline, Week 8, 6-month Follow-up
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10-item scale measuring perceived stress in the past month.
Higher scores = greater stress
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Baseline, Week 8, 6-month Follow-up
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Social Support (MOS)
Zeitfenster: Baseline, Week 8, 6-month follow-up
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Medical Outcomes Study (MOS) Social Support Scale: measures emotional, tangible, affectionate, and positive social interaction.
Higher scores = greater support.
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Baseline, Week 8, 6-month follow-up
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Caregiving Burden
Zeitfenster: Baseline, Week 8, 6 month follow-up
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Short Zarit Caregiver Burden Interview: 12-item measure of caregiver burden covering personal strain and role strain.
Higher scores = greater burden.
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Baseline, Week 8, 6 month follow-up
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Loneliness
Zeitfenster: Baseline, Week 8, 6 month follow-up
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UCLA Loneliness Scale: measures subjective feelings of loneliness and social isolation.
Higher scores = greater loneliness
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Baseline, Week 8, 6 month follow-up
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Platform Engagement
Zeitfenster: Post Intervention (week 8)
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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)
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Post Intervention (week 8)
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Problem Solving
Zeitfenster: Baseline, Week 4, Week 8, 6-month followup
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Social Problem Solving Inventory - Revised (SPSI-R): assesses problem-solving orientation and style.
Used as mechanistic measure (Aim 2a).
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Baseline, Week 4, Week 8, 6-month followup
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Health Self-Efficacy
Zeitfenster: Baseline, Week 4, Week 8, 6-month follow-up
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Health Self-Efficacy 5-item Health Self-Efficacy Measure: assesses confidence in managing health-related tasks.
Used as mechanistic measure (Aim 2a).
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Baseline, Week 4, Week 8, 6-month follow-up
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Sustained Effect on Depression (CES-D)
Zeitfenster: 6-Month Follow-up
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CES-D at 6-month follow-up: tests sustained (durable) reduction in depressive symptoms beyond the active intervention period.
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6-Month Follow-up
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Dezember 2026
Primärer Abschluss (Geschätzt)
30. November 2029
Studienabschluss (Geschätzt)
30. November 2030
Studienanmeldedaten
Zuerst eingereicht
3. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Juni 2026
Zuerst gepostet (Tatsächlich)
9. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Psychische Störungen
- Verhaltenssymptome
- Neurokognitive Störungen
- Demenz
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Stress, Psychisch
- Parkinsonsche Störungen
- Erkrankungen der Basalganglien
- Verhalten
- Belastung der Pflegekraft
- Lewy-Körper-Krankheit
Andere Studien-ID-Nummern
- A214588
- 1R01MH139601-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Zeitrahmen
Beginning 9 months after publication of primary outcome results; available for 5 years.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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