N/A
Completed N=386
Life Enhancing Activities for Family Caregivers (LEAF 2.0)
Caregivers
Source: ClinicalTrials.gov NCT03610698 ↗
Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a — 40.87; 40.73; 39.91; 42.49 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a |
40.87; 40.73; 39.91; 42.49; 41.36; 39.62 | — |
| PRIMARY Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a |
55.62; 55.73; 57.31; 54.38; 54.51; 56.35 | — |
| PRIMARY Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a |
54.85; 53.70; 55.07; 53.06; 53.67; 56.74 | — |
| PRIMARY Perceived Stress Using Perceived Stress Scale (PSS-4) |
7.08; 7.04; 7.27; 6.72; 6.53; 7.56 | — |
| SECONDARY Caregiver Burden Measured Using the Zarit Burden Interview. |
12.56; 12.12; 12.89; 12.13; 12.27; 13.09 | — |
| SECONDARY Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure |
22.74; 22.78; 21.93; 23.89; 23.79; 22.68 | — |
| SECONDARY Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale |
35.85; 36.14; 34.59; 36.72; 37.21; 33.74 | — |
| SECONDARY Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire. |
44.04; 44.81; 41.87; 45.80; 45.45; 41.98 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03610698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.