Trial Outcomes & Findings for Preventing Depressive Relapse in Pregnant Women With Recurrent Depression (NCT NCT03623620)
NCT ID: NCT03623620
Last Updated: 2023-06-06
Results Overview
Depression relapse from randomization through 6 month postpartum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
Randomization through 6 months postpartum
Results posted on
2023-06-06
Participant Flow
The UPWARD randomized clinical trial was conducted nationally, recruiting euthymic pregnant women with recurrent depression treated with antidepressants. Participant recruitment for UPWARD began March 7, 2019, and concluded July 8, 2020.
745 individuals were eligible after the initial phone screen, 512 completed the baseline interview and surveys (66 were found ineligible during the baseline interview, 20 did not complete baseline surveys within 1 week, and 147 were non-responsive to follow-up), and 500 were randomized (12 were lost to follow up before randomization).
Participant milestones
| Measure |
Digital Delivery of MBCT (Mindful Mood Balance for Moms)
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Digital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills
|
Usual Care
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
251
|
|
Overall Study
COMPLETED
|
249
|
251
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Baseline characteristics by cohort
| Measure |
Digital Delivery of MBCT (Mindful Mood Balance for Moms)
n=249 Participants
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Digital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills
|
Usual Care
n=251 Participants
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
249 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 4.65 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 4.43 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 4.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
216 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
426 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization through 6 months postpartumDepression relapse from randomization through 6 month postpartum
Outcome measures
| Measure |
Digital Delivery of MBCT (Mindful Mood Balance for Moms)
n=249 Participants
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Digital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills
|
Usual Care
n=251 Participants
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.
|
|---|---|---|
|
Number of Participants Experiencing Relapse of Depression
|
81 Participants
|
111 Participants
|
Adverse Events
Digital Delivery of MBCT (Mindful Mood Balance for Moms)
Serious events: 0 serious events
Other events: 177 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 209 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digital Delivery of MBCT (Mindful Mood Balance for Moms)
n=249 participants at risk
Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.
Digital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills
|
Usual Care
n=251 participants at risk
Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
All events categorized as "unexpected" and "non-Severe"
|
71.1%
177/249 • Number of events 177 • March 12, 2019 to September 12, 2021 (18 months)
Adverse events were probed for in every phone interview with study participants using standardized health questionnaires for each interview timepoint.
|
83.3%
209/251 • Number of events 209 • March 12, 2019 to September 12, 2021 (18 months)
Adverse events were probed for in every phone interview with study participants using standardized health questionnaires for each interview timepoint.
|
Additional Information
Lee Cohen, MD
Massachusetts General Hospital, Center for Women's Mental Health
Phone: 617-724-8020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place