Trial Outcomes & Findings for HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease (NCT NCT05129631)
NCT ID: NCT05129631
Last Updated: 2026-08-31
Results Overview
Assesses depression over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater depression. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of depression and a T-score of 70 and above is indicative of a severe level of depression.
COMPLETED
NA
30 participants
Weeks 1, 2, 3, 4, 6
2026-08-31
Participant Flow
Recruitment began in July 2023 and ended in March 2025. Perinatal nurse coordinators at Nemours Children's Health provided eligible expectant mothers with information about the research study during fetal cardiology appointments or by phone and directly referred mothers to the study. Expectant mothers were then contacted by a research team member to provide more information about the study and conduct the informed consent process.
Participant milestones
| Measure |
HEARTPrep Intervention
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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23
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
HEARTPrep Intervention
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Overall Study
Lost to Follow-up
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2
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Overall Study
Withdrawal by Subject
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1
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Overall Study
No longer eligible (early delivery, change in fetal diagnosis)
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3
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Overall Study
Participant was hospitalized (unrelated to the study)
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1
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Baseline Characteristics
17 participants completed measures at Week 0 (Baseline)
Baseline characteristics by cohort
| Measure |
HEARTPrep Intervention
n=30 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Age, Customized
18-24 years old
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4 Participants
n=14 Participants
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Age, Customized
25-29 years old
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10 Participants
n=14 Participants
|
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Age, Customized
30-34 years old
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11 Participants
n=14 Participants
|
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Age, Customized
35-43 years old
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5 Participants
n=14 Participants
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Sex: Female, Male
Female
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30 Participants
n=14 Participants
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Sex: Female, Male
Male
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0 Participants
n=14 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Black or African American
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10 Participants
n=14 Participants
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Race (NIH/OMB)
White
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19 Participants
n=14 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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29 Participants
n=14 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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Region of Enrollment
United States
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30 Participants
n=14 Participants
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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58.03 T-score
STANDARD_DEVIATION 10.92 • n=14 Participants • 17 participants completed measures at Week 0 (Baseline)
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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59.85 T-score
STANDARD_DEVIATION 12.89 • n=14 Participants • 17 participants completed measures at Week 0 (Baseline)
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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47.98 T-score
STANDARD_DEVIATION 8.41 • n=14 Participants • 17 participants completed measures at Week 0 (Baseline)
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Self-Efficacy - Short Form
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13 Scores on a scale
STANDARD_DEVIATION 3.71 • n=14 Participants • 17 participants completed measures at Week 0 (Baseline)
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Hope - Short Form
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15.47 Scores on a scale
STANDARD_DEVIATION 3.45 • n=14 Participants • 17 participants completed measures at Week 0 (Baseline)
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PRIMARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6Population: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).
Assesses depression over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater depression. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of depression and a T-score of 70 and above is indicative of a severe level of depression.
Outcome measures
| Measure |
HEARTPrep Intervention
n=24 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 1
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53.64 T-score
Standard Deviation 11.75
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 2
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54.47 T-score
Standard Deviation 10.58
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 3
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53.55 T-score
Standard Deviation 10.54
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 4
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54.97 T-score
Standard Deviation 10.93
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Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 6
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51.31 T-score
Standard Deviation 7.62
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PRIMARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6Population: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).
Assesses anxiety over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater anxiety. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of anxiety and a T-score of 70 and above is indicative of a severe level of anxiety.
Outcome measures
| Measure |
HEARTPrep Intervention
n=24 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 1
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57.53 T-score
Standard Deviation 9.60
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 2
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58.29 T-score
Standard Deviation 8.44
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 3
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56.03 T-score
Standard Deviation 10.17
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 4
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58.9 T-score
Standard Deviation 11.36
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Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 6
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55.12 T-score
Standard Deviation 8.95
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PRIMARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6Population: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).
Assesses social isolation over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater social isolation. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of social isolation and a T-score of 70 and above is indicative of a severe level of social isolation.
Outcome measures
| Measure |
HEARTPrep Intervention
n=24 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 1
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47.48 T-score
Standard Deviation 10.32
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 2
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48.53 T-score
Standard Deviation 11.89
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 3
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45.87 T-score
Standard Deviation 11.82
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 4
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47.85 T-score
Standard Deviation 10.19
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Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Week 6
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43.21 T-score
Standard Deviation 8.26
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SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6Population: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).
Assesses feelings of self-efficacy over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater self-efficacy; minimum score = 4; maximum score = 20)
Outcome measures
| Measure |
HEARTPrep Intervention
n=24 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Self-Efficacy Short-Form
Week 1
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14.14 Scores on a scale
Standard Deviation 3.90
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Self-Efficacy Short-Form
Week 2
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13.87 Scores on a scale
Standard Deviation 3.78
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Self-Efficacy Short-Form
Week 3
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14.5 Scores on a scale
Standard Deviation 3.47
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Self-Efficacy Short-Form
Week 4
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14.91 Scores on a scale
Standard Deviation 2.59
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Self-Efficacy Short-Form
Week 6
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15.6 Scores on a scale
Standard Deviation 3.92
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SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6Population: Participating mothers were asked to complete brief measures on a weekly basis throughout participation in HEARTPrep. Due to variability in timing of measure completion, weeks were defined as 1 (8-14 days after starting HEARTPrep), 2 (15-21 days), 3 (22-28 days), 4 (29-35 days), and 6 (36-49 days).
Assesses feelings of hope over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater hope; minimum score = 4; maximum score = 20)
Outcome measures
| Measure |
HEARTPrep Intervention
n=24 Participants
HEARTPrep is a prenatal psychosocial intervention aimed at improving mental health and wellbeing for mothers expecting a baby with congenital heart disease (CHD). HEARTPrep is virtually delivered via mobile app and consists of three self-paced modules containing tools for coping and videos of parents sharing their experiences and corresponding live telehealth sessions with a psychosocial provider.
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|---|---|
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Hope Short-Form
Week 1
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17.14 Scores on a scale
Standard Deviation 3.72
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Hope Short-Form
Week 2
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16.2 Scores on a scale
Standard Deviation 3.65
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Hope Short-Form
Week 3
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17 Scores on a scale
Standard Deviation 3.43
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Hope Short-Form
Week 4
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16.91 Scores on a scale
Standard Deviation 2.66
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Hope Short-Form
Week 6
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18 Scores on a scale
Standard Deviation 3.06
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Adverse Events
HEARTPrep Intervention
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