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Life Enhancing Activities for Family Caregivers (LEAF 2.0)

NCT ID: NCT03610698

Last Updated: 2025-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2024-09-04

Brief Summary

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The goal of the proposed intervention, called LEAF (Life Enhancing Activities for Family Caregivers) is to reduce burden and increase well-being in Alzheimer's Disease caregivers through the practice of positive emotion skills. We will employ two methods of online delivery of LEAF: a Zoom facilitated version and a self-guided version, and compare them to an emotion-reporting waitlist control condition. If effective, the LEAF program can be disseminated more broadly to caregivers of individuals with Alzheimer's disease.

Detailed Description

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LEAF 2.0 is a 3-arm, technology-based, randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's Disease (AD) are randomly assigned to 1) the LEAF intervention facilitated remotely via Zoom (N = 200), 2) the LEAF intervention self-guided online (N = 200), or 3) an emotion reporting control (N = 100) which will then cross over to the intervention after approximately 7 months, half to the facilitated arm and half to the self-guided arm. Participants will complete a program that teaches them eight positive emotion skills which aim to reduce stress and burden, and increase positive affect. All aspects of the study (recruitment, consent, intervention, and assessments) are conducted online.

To be eligible for participation in LEAF 2.0, participants must identify as the primary family caregiver of someone with Alzheimer's disease or Alzheimer's-related dementia, and whose care recipient is not living in a care facility at the time of enrollment. "Primary family caregiver" is defined as the person who spends the most time caring for the individual with Alzheimer's disease in a non-professional capacity. Participants must also be able to speak and read English, live in the United States, be at least 18 years of age, and have access to a reliable Wi-Fi connection. Respondents are ineligible if they have already participated in a prior version of LEAF.

Conditions

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Caregivers

Keywords

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caregiving psychological well-being Alzheimer's disease positive emotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Facilitated Intervention

Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks.

Group Type EXPERIMENTAL

LEAF Positive Emotion Intervention

Intervention Type BEHAVIORAL

5-week online intervention teaching 8 positive emotions skills for caregivers

Self-Guided Intervention

Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks.

Group Type EXPERIMENTAL

LEAF Positive Emotion Intervention

Intervention Type BEHAVIORAL

5-week online intervention teaching 8 positive emotions skills for caregivers

Emotion Reporting Control

Participants in the emotion reporting control condition will be reporting their emotions daily for the same length as the intervention, and then cross over to either the facilitated or self-guided version of the intervention.

Group Type ACTIVE_COMPARATOR

Emotion Reporting Control Condition

Intervention Type OTHER

Daily reporting of emotions for participants assigned to the control condition.

Interventions

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LEAF Positive Emotion Intervention

5-week online intervention teaching 8 positive emotions skills for caregivers

Intervention Type BEHAVIORAL

Emotion Reporting Control Condition

Daily reporting of emotions for participants assigned to the control condition.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult age 18 and over who identifies as the primary caregiver of a family member with Alzheimer's disease or probable Alzheimer's
* Care recipient does NOT reside in care facility
* Speaks and reads English
* Has access to high speed internet connection at home or a location where they can speak privately with a facilitator

Exclusion Criteria

* Care recipient lives in care facility
* Does not speak/read English
* Does not have access to internet
* Care recipient does not have Alzheimer's disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Judith Moskowitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Moskowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Leong CA, Summers A, Grote V, Jackson K, Dowling G, Snowberg K, Cotten P, Cheung E, Yang D, Addington EL, Moskowitz JT. Randomized controlled trial of a positive emotion regulation intervention to reduce stress in family caregivers of individuals with Alzheimer's disease: protocol and design for the LEAF 2.0 study. BMC Geriatr. 2024 Mar 27;24(1):289. doi: 10.1186/s12877-024-04817-5.

Reference Type DERIVED
PMID: 38539083 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SP0044459

Identifier Type: -

Identifier Source: org_study_id