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Completed

NCT Number: NCT03610698

Life Enhancing Activities for Family Caregivers (LEAF 2.0)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEAF Positive Emotion Intervention

Behavioral

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

Emotion Reporting Control Condition

Other

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

Primary outcomes

  1. Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  2. Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  3. Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  4. Perceived Stress Using Perceived Stress Scale (PSS-4)

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

Secondary outcomes

  1. Caregiver Burden Measured Using the Zarit Burden Interview.

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

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

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  3. Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  4. Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire.

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

Other outcomes

  1. 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

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

  2. Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b

    Time frame: Baseline and 8 weeks post-intervention start date

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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