Trial Outcomes & Findings for Life Enhancing Activities for Family Caregivers (LEAF 2.0) (NCT NCT03610698)
NCT ID: NCT03610698
Last Updated: 2025-12-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
386 participants
Primary outcome timeframe
Baseline and 8 weeks post-intervention start date
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
154
|
157
|
38
|
37
|
|
Overall Study
COMPLETED
|
146
|
142
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Life Enhancing Activities for Family Caregivers (LEAF 2.0)
Baseline characteristics by cohort
| Measure |
Self-Guided Intervention
n=157 Participants
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
|
Facilitated Intervention
n=154 Participants
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
|
Emotion Reporting Control Facilitated Crossover
n=38 Participants
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.
|
Emotion Reporting Control Self-Guided Crossover
n=37 Participants
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.
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=4 Participants
|
80 Participants
n=68 Participants
|
20 Participants
n=219 Participants
|
20 Participants
n=219 Participants
|
210 Participants
n=880 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=4 Participants
|
74 Participants
n=68 Participants
|
18 Participants
n=219 Participants
|
17 Participants
n=219 Participants
|
176 Participants
n=880 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
133 Participants
n=4 Participants
|
132 Participants
n=68 Participants
|
33 Participants
n=219 Participants
|
32 Participants
n=219 Participants
|
330 Participants
n=880 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
23 Participants
n=4 Participants
|
22 Participants
n=68 Participants
|
5 Participants
n=219 Participants
|
5 Participants
n=219 Participants
|
55 Participants
n=880 Participants
|
|
Sex/Gender, Customized
Gender · Prefer Not to Answer
|
1 Participants
n=4 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=4 Participants
|
8 Participants
n=68 Participants
|
2 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
19 Participants
n=880 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=4 Participants
|
146 Participants
n=68 Participants
|
36 Participants
n=219 Participants
|
36 Participants
n=219 Participants
|
367 Participants
n=880 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=4 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=4 Participants
|
9 Participants
n=68 Participants
|
4 Participants
n=219 Participants
|
2 Participants
n=219 Participants
|
25 Participants
n=880 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=4 Participants
|
137 Participants
n=68 Participants
|
33 Participants
n=219 Participants
|
34 Participants
n=219 Participants
|
346 Participants
n=880 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=4 Participants
|
2 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
5 Participants
n=68 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
|
Region of Enrollment
United States
|
157 participants
n=4 Participants
|
154 participants
n=68 Participants
|
38 participants
n=219 Participants
|
37 participants
n=219 Participants
|
386 participants
n=880 Participants
|
|
PROMIS Positive Affect
|
40.73 units on a scale
STANDARD_DEVIATION 8.47 • n=4 Participants
|
40.87 units on a scale
STANDARD_DEVIATION 8.88 • n=68 Participants
|
40.51 units on a scale
STANDARD_DEVIATION 7.71 • n=219 Participants
|
39.29 units on a scale
STANDARD_DEVIATION 7.83 • n=219 Participants
|
40.63 units on a scale
STANDARD_DEVIATION 8.49 • n=880 Participants
|
|
PROMIS Depression
|
53.70 units on a scale
STANDARD_DEVIATION 7.29 • n=4 Participants
|
54.85 units on a scale
STANDARD_DEVIATION 7.80 • n=68 Participants
|
54.08 units on a scale
STANDARD_DEVIATION 7.48 • n=219 Participants
|
56.08 units on a scale
STANDARD_DEVIATION 7.67 • n=219 Participants
|
54.42 units on a scale
STANDARD_DEVIATION 7.56 • n=880 Participants
|
|
PROMIS Anxiety
|
55.73 units on a scale
STANDARD_DEVIATION 7.66 • n=4 Participants
|
55.62 units on a scale
STANDARD_DEVIATION 8.65 • n=68 Participants
|
55.89 units on a scale
STANDARD_DEVIATION 7.48 • n=219 Participants
|
58.78 units on a scale
STANDARD_DEVIATION 8.10 • n=219 Participants
|
56.00 units on a scale
STANDARD_DEVIATION 8.11 • n=880 Participants
|
|
Perceived Stress (PSS)
|
7.04 units on a scale
STANDARD_DEVIATION 3.10 • n=4 Participants
|
7.08 units on a scale
STANDARD_DEVIATION 3.13 • n=68 Participants
|
6.82 units on a scale
STANDARD_DEVIATION 2.88 • n=219 Participants
|
7.73 units on a scale
STANDARD_DEVIATION 3.09 • n=219 Participants
|
7.10 units on a scale
STANDARD_DEVIATION 3.08 • n=880 Participants
|
|
Zarit Burden Score
|
12.12 units on a scale
STANDARD_DEVIATION 4.94 • n=4 Participants
|
12.56 units on a scale
STANDARD_DEVIATION 5.64 • n=68 Participants
|
12.21 units on a scale
STANDARD_DEVIATION 5.04 • n=219 Participants
|
13.59 units on a scale
STANDARD_DEVIATION 5.58 • n=219 Participants
|
12.45 units on a scale
STANDARD_DEVIATION 5.30 • n=880 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post-assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a
Baseline
|
40.87 score on a scale
Standard Error 0.71
|
40.73 score on a scale
Standard Error 0.71
|
39.91 score on a scale
Standard Error 1.02
|
|
Positive Emotion Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Positive Affect 15a
8 weeks post-intervention start date
|
42.49 score on a scale
Standard Error 0.75
|
41.36 score on a scale
Standard Error 0.77
|
39.62 score on a scale
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a
Baseline
|
55.62 score on a scale
Standard Error 0.69
|
55.73 score on a scale
Standard Error 0.68
|
57.31 score on a scale
Standard Error 0.98
|
|
Anxiety Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Anxiety 8a
8 weeks post-intervention start date
|
54.38 score on a scale
Standard Error 0.71
|
54.51 score on a scale
Standard Error 0.74
|
56.35 score on a scale
Standard Error 1.02
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a
Baseline
|
54.85 score on a scale
Standard Error 0.61
|
53.70 score on a scale
Standard Error 0.61
|
55.07 score on a scale
Standard Error 0.88
|
|
Depression Assessed Using Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a
8 weeks post-intervention start date
|
53.06 score on a scale
Standard Error 0.64
|
53.67 score on a scale
Standard Error 0.66
|
56.74 score on a scale
Standard Error 0.91
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Perceived Stress Using Perceived Stress Scale (PSS-4)
Baseline
|
7.08 score on a scale
Standard Error 0.26
|
7.04 score on a scale
Standard Error 0.25
|
7.27 score on a scale
Standard Error 0.37
|
|
Perceived Stress Using Perceived Stress Scale (PSS-4)
8 weeks post-intervention start date
|
6.72 score on a scale
Standard Error 0.27
|
6.53 score on a scale
Standard Error 0.28
|
7.56 score on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Caregiver Burden Measured Using the Zarit Burden Interview.
Baseline
|
12.56 score on a scale
Standard Error 0.42
|
12.12 score on a scale
Standard Error 0.41
|
12.89 score on a scale
Standard Error 0.60
|
|
Caregiver Burden Measured Using the Zarit Burden Interview.
8 weeks post-intervention start date
|
12.13 score on a scale
Standard Error 0.44
|
12.27 score on a scale
Standard Error 0.45
|
13.09 score on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure
Baseline
|
22.74 score on a scale
Standard Error 0.32
|
22.78 score on a scale
Standard Error 0.32
|
21.93 score on a scale
Standard Error 0.46
|
|
Caregiver Self-efficacy/Mastery Measured Using the Caregiving Mastery Subscale of the Caregiving Appraisal Measure
8 weeks post-intervention start date
|
23.89 score on a scale
Standard Error 0.34
|
23.79 score on a scale
Standard Error 0.35
|
22.68 score on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale
Baseline
|
35.85 score on a scale
Standard Error 0.78
|
36.14 score on a scale
Standard Error 0.77
|
34.59 score on a scale
Standard Error 1.12
|
|
Positive Aspects of Caregiving Measured Using the Positive Aspects of Caregiving Scale
8 weeks post-intervention start date
|
36.72 score on a scale
Standard Error 0.82
|
37.21 score on a scale
Standard Error 0.85
|
33.74 score on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire.
8 weeks post-intervention start date
|
45.80 score on a scale
Standard Error 0.74
|
45.45 score on a scale
Standard Error 0.75
|
41.98 score on a scale
Standard Error 1.03
|
|
Quality of Care Measured Using the Satisfaction of One's Own Performance as a Caregiver Subscale of the Sense of Competence Questionnaire.
Baseline
|
44.04 score on a scale
Standard Error 0.69
|
44.81 score on a scale
Standard Error 0.69
|
41.87 score on a scale
Standard Error 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
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
|
47.28 score on a scale
Standard Error 0.86
|
47.85 score on a scale
Standard Error 0.85
|
46.61 score on a scale
Standard Error 1.23
|
|
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
8 weeks post-intervention start date
|
49.11 score on a scale
Standard Error 0.89
|
48.20 score on a scale
Standard Error 0.92
|
46.39 score on a scale
Standard Error 1.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeks post-intervention start datePopulation: Not all enrolled participants completed the post assessment.
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.
Outcome measures
| Measure |
Facilitated Intervention
n=154 Participants
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
|
Self-Guided Intervention
n=157 Participants
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
|
Emotion Reporting Control
n=75 Participants
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.
|
|---|---|---|---|
|
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
|
53.72 score on a scale
Standard Error 0.72
|
54.78 score on a scale
Standard Error 0.71
|
54.53 score on a scale
Standard Error 1.03
|
|
Sleep Disturbance as Part of Psychological Well-Being, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0--Sleep Disturbance 8b
8 weeks post-intervention start date
|
51.80 score on a scale
Standard Error 0.75
|
53.58 score on a scale
Standard Error 0.78
|
55.37 score on a scale
Standard Error 1.08
|
Adverse Events
Facilitated Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Guided Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Emotion Reporting Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place