VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia
BehavioralThe 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).
Standard of Care Educational Materials
Other interventionNIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email or mail per participant preference.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: VOCALE LBDExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depressive Symptoms, Center for Epidemiologic Studies Depression Scale (CES-D)
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
Time frame
Baseline (pre-randomization), Post-Intervention (Week 8), 6-Month Follow-UpSecondary outcomes
1
Perceived stress (PSS)
10-item scale measuring perceived stress in the past month. Higher scores = greater stress
Time frame
Baseline, Week 8, 6-month Follow-up2
Social Support (MOS)
Medical Outcomes Study (MOS) Social Support Scale: measures emotional, tangible, affectionate, and positive social interaction. Higher scores = greater support.
Time frame
Baseline, Week 8, 6-month follow-up3
Caregiving Burden
Short Zarit Caregiver Burden Interview: 12-item measure of caregiver burden covering personal strain and role strain. Higher scores = greater burden.
Time frame
Baseline, Week 8, 6 month follow-up4
Loneliness
UCLA Loneliness Scale: measures subjective feelings of loneliness and social isolation. Higher scores = greater loneliness
Time frame
Baseline, Week 8, 6 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
The Lewy Body Dementia Association (LBDA)
Collaborator
National Institute on Aging (NIA)
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
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