NCT05274074

Social-LEAF Life Enhancing Activities for Caregivers

Improving Care Partner Outcomes Through Positive Connections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

The objective of the Social-LEAF study 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 up to 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.

Conditions

• Social Connectedness

Interventions

Type	Name	Description
BEHAVIORAL	Social LEAF	Social LEAF is an adaptation of the Life Enhancing Activities for Family Caregivers program to focus on social relationships and loneliness. Social LEAF is a six-session group program provided by video-conference that teaches caregivers coping skills to improve social relationships and social connection. Social LEAF is delivered in groups of up to 10 caregivers via videoconference and will consist of six weekly hour-long discussion-based classes to teach positive coping skills around improving social relationships. Each week will focus on a skill from the original LEAF study adapted to the group and social context.

Timeline

• Start date: 2022-07-28
• Primary completion: 2023-07-23
• Completion: 2023-07-23
• First posted: 2022-03-10
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: United States