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

Official title

Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.

Overview

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.

Interventions

• 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 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 measures

• Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-Up]

Secondary outcome measures (8)

• Perceived stress (PSS) [Time frame: Baseline, Week 8, 6-month Follow-up]
• Social Support (MOS) [Time frame: Baseline, Week 8, 6-month follow-up]
• Caregiving Burden [Time frame: Baseline, Week 8, 6 month follow-up]
• Loneliness [Time frame: Baseline, Week 8, 6 month follow-up]
• Platform Engagement [Time frame: Post Intervention (week 8)]
• Problem Solving [Time frame: Baseline, Week 4, Week 8, 6-month followup]
• Health Self-Efficacy [Time frame: Baseline, Week 4, Week 8, 6-month follow-up]
• Sustained Effect on Depression (CES-D) [Time frame: 6-Month Follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Washington — Seattle

Identifiers

NCT: NCT07637097 · A214588 · 1R01MH139601-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗