Life Enhancing Activities for Family Caregivers (LEAF 2.0)

Northwestern University

Status: Completed

Conditions: Caregivers

Treatments: Other: Emotion Reporting Control Condition; Behavioral: LEAF Positive Emotion Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03610698

SP0044459

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 386 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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386 participants in 3 patient groups

Facilitated Intervention

Experimental group

Description:

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

Treatment:

Behavioral: LEAF Positive Emotion Intervention

Self-Guided Intervention

Experimental group

Description:

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

Treatment:

Behavioral: LEAF Positive Emotion Intervention

Emotion Reporting Control

Active Comparator group

Description:

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.

Treatment:

Other: Emotion Reporting Control Condition