Trial Outcomes & Findings for Telehealth Group Intervention for Perinatal Depressive Symptoms (NCT NCT03932760)
NCT ID: NCT03932760
Last Updated: 2024-06-04
Results Overview
Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores \< 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; \> 20 = severe.
COMPLETED
NA
99 participants
Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention
2024-06-04
Participant Flow
During the period from May 1, 2020 through May 31, 2022, 535 women were reached out to for participation in the study. Participants were recruited from University of Utah UHealth clinics as well as rural health districts.
Out of the 535 women reached out to, 331 were unable to be contacted after four attempts. Of the remaining 204, 58 were ineligible for a combination of non-mutually exclusive factors including mental health diagnoses (n= 35), medication changes in the last 6 weeks (n=15), \>6 months postpartum (n=9), and other (n=6). Of the 147 who remained eligible to participate, 99 were consented. Of these, 17 were lost to contact prior to randomization, and 81participants were randomized.
Participant milestones
| Measure |
UPLIFT Program
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Pregnancy Skills Group
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
Baseline
|
36
|
33
|
|
Overall Study
Post
|
29
|
30
|
|
Overall Study
2 Months
|
31
|
29
|
|
Overall Study
4 Months
|
31
|
29
|
|
Overall Study
6 Months
|
30
|
28
|
|
Overall Study
8 Months
|
30
|
28
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
UPLIFT Program
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Pregnancy Skills Group
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
|---|---|---|
|
Overall Study
Became Ineligible
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
Baseline Characteristics
Telehealth Group Intervention for Perinatal Depressive Symptoms
Baseline characteristics by cohort
| Measure |
UPLIFT Program
n=40 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Pregnancy Skills Group
n=41 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30 years
n=99 Participants
|
31 years
n=107 Participants
|
31 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
41 participants
n=107 Participants
|
81 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-interventionPopulation: Number Analyzed differs from Overall Number of Participants Analyzed due to participants becoming ineligible, withdrawing, and opting to not complete surveys at certain time points.
Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores \< 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; \> 20 = severe.
Outcome measures
| Measure |
UPLIFT Program
n=40 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Pregnancy Skills Group
n=41 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
|---|---|---|
|
Change in Depressive Symptoms Over Time
Baseline
|
11.11 units on a scale
Standard Deviation 3.85
|
10.52 units on a scale
Standard Deviation 4.52
|
|
Change in Depressive Symptoms Over Time
Post
|
7.34 units on a scale
Standard Deviation 2.79
|
7.69 units on a scale
Standard Deviation 3.92
|
|
Change in Depressive Symptoms Over Time
2 months
|
8.84 units on a scale
Standard Deviation 3.45
|
8.90 units on a scale
Standard Deviation 5.31
|
|
Change in Depressive Symptoms Over Time
4 months
|
8.52 units on a scale
Standard Deviation 4.62
|
7.10 units on a scale
Standard Deviation 4.80
|
|
Change in Depressive Symptoms Over Time
6 months
|
8.16 units on a scale
Standard Deviation 5.52
|
6.35 units on a scale
Standard Deviation 4.49
|
|
Change in Depressive Symptoms Over Time
8 months
|
6.70 units on a scale
Standard Deviation 2.90
|
6.33 units on a scale
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Time 1 = pre-intervention; T2 = immediately following week 9 of group intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-interventionPopulation: Number Analyzed differs from Overall Number of Participants Analyzed due to participants becoming ineligible, withdrawing, and opting to not complete surveys at certain time points.
Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of \< 5 = no anxiety; 5-9 = mild; 10-14 = moderate; \> 15 = severe.
Outcome measures
| Measure |
UPLIFT Program
n=40 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
Pregnancy Skills Group
n=41 Participants
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
|
|---|---|---|
|
Change in Anxiety Symptoms Over Time
Baseline
|
6.97 units on a scale
Standard Deviation 3.01
|
6.97 units on a scale
Standard Deviation 3.01
|
|
Change in Anxiety Symptoms Over Time
Post
|
5.17 units on a scale
Standard Deviation 3.34
|
5.17 units on a scale
Standard Deviation 3.34
|
|
Change in Anxiety Symptoms Over Time
2 months
|
6.31 units on a scale
Standard Deviation 4.04
|
6.31 units on a scale
Standard Deviation 4.04
|
|
Change in Anxiety Symptoms Over Time
4 months
|
5.45 units on a scale
Standard Deviation 3.34
|
5.45 units on a scale
Standard Deviation 3.34
|
|
Change in Anxiety Symptoms Over Time
6 months
|
4.74 units on a scale
Standard Deviation 4.18
|
4.74 units on a scale
Standard Deviation 4.18
|
|
Change in Anxiety Symptoms Over Time
8 months
|
4.35 units on a scale
Standard Deviation 2.68
|
4.35 units on a scale
Standard Deviation 2.68
|
Adverse Events
UPLIFT Program
Pregnancy Skills Group
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