Trial Outcomes & Findings for SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support (NCT NCT05562583)
NCT ID: NCT05562583
Last Updated: 2023-10-24
Results Overview
This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Post-study (week 6)
Results posted on
2023-10-24
Participant Flow
Participants were recruited from a group of individuals who responded to social media advertisements for another caregiver study but were not eligible (3/15, 20%) and from dementia caregiver support groups (12/15, 80%).
Participant milestones
| Measure |
Intervention (Single Arm)
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Baseline characteristics by cohort
| Measure |
Intervention (Single Arm)
n=15 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Age, Continuous
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62.8 years
STANDARD_DEVIATION 11.31 • n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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15 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Duration of caregiving
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4.27 years
STANDARD_DEVIATION 2.94 • n=5 Participants
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Diagnosis
Frontotemporal dementia
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11 Participants
n=5 Participants
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Diagnosis
Uncategorized dementia
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4 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Post-study (week 6)This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.
Outcome measures
| Measure |
Intervention (Single Arm)
n=15 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant
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72 Percentage of skill pages
Standard Deviation 42
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PRIMARY outcome
Timeframe: Post-study (week 6)This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Willingness to Recommend SAGE-LEAF to Other AD Caregivers
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8 score on a scale
Interval 6.25 to 9.5
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PRIMARY outcome
Timeframe: Post-study (week 6)This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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System Usability Scale
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73.75 score on a scale
Interval 57.5 to 85.63
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Zarit Burden Interview
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15.67 score on a scale
Standard Deviation 3.54
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Oberst Caregiving Burden Scale - Time
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3.07 score on a scale
Standard Deviation 0.75
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Oberst Caregiving Burden Scale - Difficulty
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2.77 score on a scale
Standard Deviation 0.82
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring positive aspects to caregiving for dementia patients. Score range: 5-45. Higher scores indicate better caregivers' outlook on life and self-affirmations.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Positive Aspects of Caregiving Scale
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22.23 score on a scale
Standard Deviation 9.27
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Role Captivity Sub-scale of Caregiver Reaction Assessment
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2.55 score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Overload Sub-scale of Caregiver Reaction Assessment
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2.65 score on a scale
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Caregiving Mastery Subscale of the Caregiving Appraisal Measure
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2.66 score on a scale
Standard Deviation 0.45
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Cohen's Perceived Stress Scale
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7.5 score on a scale
Standard Deviation 1.78
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Positive Affect in Differential Emotions Scale
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1.82 score on a scale
Standard Deviation 0.68
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Negative Affect in Differential Emotions Scale
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1.34 score on a scale
Standard Deviation 0.72
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Patient-Reported Outcomes Measurement Information System - Depression
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57.96 score on a scale
Standard Deviation 5.05
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Patient-Reported Outcomes Measurement Information System - Anxiety
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57.45 score on a scale
Standard Deviation 7.96
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
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52.73 score on a scale
Standard Deviation 7.27
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Patient-Reported Outcomes Measurement Information System - Meaning and Purpose
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47.19 score on a scale
Standard Deviation 5.63
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SECONDARY outcome
Timeframe: Pre-study and post-study (week 6)Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.
Outcome measures
| Measure |
Intervention (Single Arm)
n=10 Participants
5 session self-guided online delivered positive emotion regulation intervention with social components.
SAGE LEAF: SAGE LEAF covers 8 skills and each skill has related home-practice activities that "unlock" every week. Each week will consist of 1-2 days of didactic material and 5-6 days of real-life home practice. Participants can access the skills at their own leisure and as often as they'd like within that week. Participants cannot skip modules with didactic material and can only progress to the next lesson if they have completed the current one. However, participants can return to old lessons or exercises if they choose to do so at a later time.
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Patient-Reported Outcomes Measurement Information System - Social Isolation
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51.27 score on a scale
Standard Deviation 5.73
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Adverse Events
Intervention (Single Arm)
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