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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facilitated Intervention | Experimental | Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks. |
|
| Self-Guided Intervention | Experimental | Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEAF Positive Emotion Intervention | Behavioral | 5-week online intervention teaching 8 positive emotions skills for caregivers |
|
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Moskowitz, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38539083 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facilitated Intervention | Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
| FG001 | Self-Guided Intervention | Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
| FG002 | Emotion Reporting Control Crossover to Facilitated | Participants in the emotion reporting control condition (crossover to facilitated) will be reporting their emotions daily for the same length as the intervention. After six months, they will cross over to the facilitated intervention. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. |
| FG003 | Emotion Reporting Control Crossover to Self-Guided | Participants in the emotion reporting control condition (crossover to self-guided) will be reporting their emotions daily for the same length as the intervention. After six months, they will cross over to the self-guided intervention. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Facilitated Intervention | Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
| BG001 | Self-Guided Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Not all enrolled participants completed the post-assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
Adverse event data were monitored for each participant from baseline through their final assessment, for a total enrollment period of 18 months.
A team statistician reviewed the proportion of LEAF participants who crossed the threshold for possible depressive disorder, assessing changes bi-monthly. Any concerns about rates of increased depressive symptoms were to be reviewed with the PI. Safety monitoring occurred at the aggregate level (i.e., rates of change within the sample), given that this was a MINIMAL RISK TRIAL.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facilitated Intervention | Intervention arm facilitated by a trained team member, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Northwestern University | 3125035247 | amanda.summers@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2022 | Aug 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2025 | Nov 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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| Emotion Reporting Control Condition | Other | Daily reporting of emotions for participants assigned to the control condition. |
|
| 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 |
| 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 |
Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
| BG002 | Emotion Reporting Control Facilitated Crossover | Participants in the emotion reporting control facilitated crossover condition will be reporting their emotions daily for the same length as the intervention before crossing over to the facilitated intervention after 6 months.. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. |
| BG003 | Emotion Reporting Control Self-Guided Crossover | Participants in the emotion reporting control self-guided crossover condition will be reporting their emotions daily for the same length as the intervention before crossing over to the self-guided intervention after 6 months. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex/Gender, Customized | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| PROMIS Positive Affect | Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a , which assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement. Higher scores indicate higher levels of positive affect. 50 indicates the population mean with a standard deviation of 10. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Depression | Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Depression 8a which assesses self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate higher levels of depression. 50 indicates the population mean with a standard deviation of 10. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Anxiety | Measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0- Anxiety 8a, which assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores indicate higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress (PSS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Zarit Burden Score | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Self-Guided Intervention | Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers |
| OG002 | Emotion Reporting Control | Participants in the emotion reporting control condition will be reporting their emotions daily for the same length as the intervention. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. |
|
|
| Primary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Primary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Primary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Secondary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Secondary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Secondary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Secondary | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Other Pre-specified | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| Other Pre-specified | 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. | Not all enrolled participants completed the post assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 8 weeks post-intervention start date |
|
|
|
| 0 |
| 154 |
| 0 |
| 154 |
| 0 |
| 154 |
| EG001 | Self-Guided Intervention | Intervention arm that is self-guided on an online platform, delivering the 8 positive emotion skills over 5 weeks. LEAF Positive Emotion Intervention: 5-week online intervention teaching 8 positive emotions skills for caregivers | 0 | 157 | 0 | 157 | 0 | 157 |
| EG002 | Emotion Reporting Control | Participants in the emotion reporting control condition will be reporting their emotions daily for the same length as the intervention. Emotion Reporting Control Condition: Daily reporting of emotions for participants assigned to the control condition. | 0 | 75 | 0 | 75 | 0 | 75 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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| 8 weeks post-intervention start date |
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