Trial Outcomes & Findings for Mommy-Baby Treatment for Perinatal Depression (NCT NCT01744041)
NCT ID: NCT01744041
Last Updated: 2022-01-11
Results Overview
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum
Results posted on
2022-01-11
Participant Flow
Participant milestones
| Measure |
Dyadic Interpersonal Psychotherapy
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
|
Enhanced Treatment as Usual
Personalized referral to community resources for depression treatment
Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mommy-Baby Treatment for Perinatal Depression
Baseline characteristics by cohort
| Measure |
Dyadic Interpersonal Psychotherapy
n=21 Participants
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
|
Enhanced Treatment as Usual
n=21 Participants
Personalized referral to community resources for depression treatment
Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.
|
Total
n=42 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
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 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
|
26.9 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
26.38 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
26.64 years
STANDARD_DEVIATION 5.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Edinburgh Depression Scale score
|
17.81 units on a scale
STANDARD_DEVIATION 3.71 • n=5 Participants
|
17.90 units on a scale
STANDARD_DEVIATION 4.60 • n=7 Participants
|
17.86 units on a scale
STANDARD_DEVIATION 4.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartumPopulation: Data shown are for the participants who completed study questionnaires at that time-point. Due to participant drop-out, this number may be less than the overall number of participants analyzed.
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Outcome measures
| Measure |
Dyadic Interpersonal Psychotherapy
n=21 Participants
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Dyadic Interpersonal Psychotherapy: This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
|
Enhanced Treatment as Usual
n=21 Participants
Personalized referral to community resources for depression treatment
Enhanced Treatment as Usual: This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.
|
|---|---|---|
|
Change in Edinburgh Depression Scale From Baseline
Baseline Score
|
17.81 units on a scale
Standard Deviation 3.71
|
17.9 units on a scale
Standard Deviation 4.6
|
|
Change in Edinburgh Depression Scale From Baseline
37-39 week gestation score
|
12.04 units on a scale
Standard Deviation 1.22
|
11.41 units on a scale
Standard Deviation 1.72
|
|
Change in Edinburgh Depression Scale From Baseline
3-month postpartum score
|
11.0 units on a scale
Standard Deviation 6.1
|
10.3 units on a scale
Standard Deviation 6.8
|
|
Change in Edinburgh Depression Scale From Baseline
6-month postpartum score
|
9.5 units on a scale
Standard Deviation 2.9
|
9.4 units on a scale
Standard Deviation 5.8
|
|
Change in Edinburgh Depression Scale From Baseline
9-month postpartum score
|
10.6 units on a scale
Standard Deviation 5.9
|
9.4 units on a scale
Standard Deviation 4.7
|
|
Change in Edinburgh Depression Scale From Baseline
12-month postpartum score
|
10.8 units on a scale
Standard Deviation 4.0
|
8.8 units on a scale
Standard Deviation 4.9
|
Adverse Events
Dyadic Interpersonal Psychotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Treatment as Usual
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
Dr. Shannon Lenze
Washington University - School of Medicine
Phone: 3143622752
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place