Life Enhancing Activities for Family Caregivers (LEAF 2.0)

NCT03610698 | Completed Results

• 1 other identifier: SP0044459
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregivers

Keywords

caregiving; psychological well-being; Alzheimer's disease; positive emotion

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Caregiver Burden Measured Using the Zarit Burden Interview.

  Baseline and 8 weeks post-intervention start date

• Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure

  Baseline and 8 weeks post-intervention start date

• Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale

  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.

  Baseline and 8 weeks post-intervention start date

Other Outcomes (2)

• 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

  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

  Baseline and 8 weeks post-intervention start date

Study Arms (3)

Facilitated Intervention

EXPERIMENTAL

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

Behavioral: LEAF Positive Emotion Intervention

Self-Guided Intervention

EXPERIMENTAL

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

Behavioral: LEAF Positive Emotion Intervention

Emotion Reporting Control

ACTIVE COMPARATOR

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

Interventions

LEAF Positive Emotion Intervention BEHAVIORAL

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

Facilitated Intervention; Self-Guided Intervention

Emotion Reporting Control Condition OTHER

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

Emotion Reporting Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 38539083 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Alzheimer Disease

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Project Manager
• Organization: Northwestern University

amanda.summers@northwestern.edu

3125035247

Study Officials

• Judith Moskowitz, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 1, 2018
• Study Start: July 13, 2020
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-11

Locations

US (1)