Life Enhancing Activities for Family Caregivers (LEAF 2.0)

Randomized Trial of a Technology-based Positive Emotion Intervention for Informal Caregivers of Individuals With Alzheimer's Disease

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.

Study Overview

• Status: Completed
• Conditions: Caregivers
• Intervention / Treatment: Behavioral: LEAF Positive Emotion Intervention; Other: Emotion Reporting Control Condition

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitated Intervention; Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks.	Behavioral: LEAF Positive Emotion Intervention; 5-week online intervention teaching 8 positive emotions skills for caregivers
Experimental: Self-Guided Intervention; Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks.	Behavioral: LEAF Positive Emotion Intervention; 5-week online intervention teaching 8 positive emotions skills for caregivers
Active Comparator: 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.	Other: Emotion Reporting Control Condition; Daily reporting of emotions for participants assigned to the control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a	Assess momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement, over the past 7 days, using a scale of not at all to very much. Higher scores indicate higher levels of positive affect. 50 indicates the population mean with a standard deviation of 10.	Baseline and 8 weeks post-intervention start date
Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a	Assesses anxiety by having participants rate items focused on anxiety symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10.	Baseline and 8 weeks post-intervention start date
Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a	Assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of depression. 50 indicates the population mean with a standard deviation of 10.	Baseline and 8 weeks post-intervention start date
Perceived Stress Using Perceived Stress Scale (PSS-4)	Used to measure how overloaded, unpredictable, and uncontrollable respondents perceive their lives to be. Scores range from 0 to 40, and higher scores indicate a higher stress level.	Baseline and 8 weeks post-intervention start date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden Measured Using the Zarit Burden Interview.	Assesses perceived burden in caregivers by assessing subjective feelings of the impact of caregiving on emotional and physical health, financial strain, and social functioning. Scale values range from "Never" (0) to "Nearly Always" (4) with higher scores reflect greater burden. Score is a summation of the 6 items.	Baseline and 8 weeks post-intervention start date
Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure	12-item Caregiving Mastery subscale of the Caregiving Appraisal Measure. Values range from "Disagree a lot" to "Agree a lot" and "Never" to "Nearly Always" with higher scores indicating higher feelings of caregiving mastery. The total score can range from 6 to 30.	Baseline and 8 weeks post-intervention start date
Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale	11-item scale that identifies positive consequences of caregiving, such as feeling more useful, feeling appreciated, and strengthening relationships with others. Values range from "Disagree a lot" to "Agree a lot." Higher scores indicate greater identification of the positives of being a caregiver. The total score can range from 11 to 55.	Baseline and 8 weeks post-intervention start date
Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire.	12-item subscale that measures the caregiver's self-evaluations of their caregiving effectiveness, such as how useful they feel in their interactions with the patient and their capability in caring for the patient. Values range from "No! (Disagree very strongly)" to "Yes! (Agree very strongly)." Higher scores indicate higher satisfaction with performance as a caregiver. The total score for this subscale ranges from 12 to 48.	Baseline and 8 weeks post-intervention start date

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meaning and Purpose as Part of Psychological Well-Being, Measured Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Meaning and Purpose 8a	Assesses the degree to which one feels life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. Scale values range from "Strongly disagree" to "Strongly agree" on items 1-3, and "Not at all" to "Very much" on items 4-8, with higher values associated with a higher sense of meaning and purpose. 50 indicates the population mean with a standard deviation of 10.	Baseline and 8 weeks post-intervention start date
Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b	Measures self-reported perceptions of sleep quality, depth, and restoration within the past 7 days, including difficulty falling asleep and staying asleep and sleep satisfaction. Values range from "Not at all" to "very much" on items 1-4, "Never" to "Always" on items 5-7, and "Very poor" to "Very good" on item 8. Higher scores indicate higher levels of sleep disturbance. 50 indicates the population mean with a standard deviation of 10.	Baseline and 8 weeks post-intervention start date

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Judith Moskowitz, PhD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): September 4, 2024

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer's disease; caregiving; psychological well-being; positive emotion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Behavior; Personal Satisfaction; Alzheimer Disease; Psychological Well-Being
• Other Study ID Numbers: SP0044459

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No