Recruiting

VOCALE LBD

Sponsor:

University of Washington

Code:

NCT07637097

Conditions

Lewy Bodies Disease

Depression Disorder

Caregiver Burden

Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia

Standard of Care Educational Materials

Study Details

Brief 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. 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.

Conditions

Lewy Bodies Disease

Depression Disorder

Caregiver Burden

Caregivers

Study ID

NCT07637097

Start date

Dec 1, 2026

Status verified date

Oct, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Has an active email address OR is willing to create and use an email address prior to enrollment

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 Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 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).

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.

Interventions

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 (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 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.

Primary outcome measure

  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline (pre-randomization), Post-intervention (Week 8), 6-month follow-up ]

Central Contacts and Locations

Central contacts

Aimy Paulsen, MPH

(253) 693-8329vocale-lbd@uw.edu

Oleg Zaslavsky, PhD, RN

(206) 849-3301zaslav@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Aimy Paulsen, MPH

(253) 693-8329vocale-lbd@uw.edu

Oleg Zaslavsky, PhD, RN

(206) 849-3301zaslav@uw.edu

Principal Investigator:

Oleg Zaslavsky, PhD, RN

More Information

Sponsor

University of Washington

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by University of Washington on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.