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Clinical Trial Summary

This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB). The intervention is called Social LEAF. The objective is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods. Aim 1 is to refine the LEAF intervention to target social relationships and loneliness. Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers. Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05274074
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase N/A
Start date July 28, 2022
Completion date July 23, 2023

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