An interventional study of Dyadic Interpersonal Psychotherapy and Enhanced Treatment as Usual in Depressive Disorder, Major and Postpartum Depression, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 42 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Behavioral: Dyadic Interpersonal Psychotherapy
Personalized referral to community resources for depression treatment
Other: Enhanced Treatment as Usual
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.
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
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Time frame: 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
| Milestone | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual |
|---|---|---|
| Started | 21 | 21 |
| Completed | 15 | 13 |
| Not completed | 6 | 8 |
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
| units on a scale | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual |
|---|---|---|
| Baseline Score | 17.81 ± 3.71 | 17.9 ± 4.6 |
| 37-39 week gestation score | 12.04 ± 1.22 | 11.41 ± 1.72 |
| 3-month postpartum score | 11.0 ± 6.1 | 10.3 ± 6.8 |
| 6-month postpartum score | 9.5 ± 2.9 | 9.4 ± 5.8 |
| 9-month postpartum score | 10.6 ± 5.9 | 9.4 ± 4.7 |
| 12-month postpartum score | 10.8 ± 4.0 | 8.8 ± 4.9 |
Collected over Baseline to 12 months postpartum, ranging from 14 to 40 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dyadic Interpersonal Psychotherapy | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Enhanced Treatment as Usual | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Mean | 26.9 ± 5.81 | 26.38 ± 5.9 | 26.64 ± 5.79 |
| Sex: Female, Male(Participants) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 20 | 41 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 17 | 16 | 33 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Edinburgh Depression Scale score(units on a scale) | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Mean | 17.81 ± 3.71 | 17.90 ± 4.60 | 17.86 ± 4.13 |
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Washington University School of Medicine