Depressive Disorder, Major, Postpartum Depression
Conditions
Keywords
depression, pregnancy, postpartum, psychotherapy
Brief summary
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.
Interventions
BEHAVIORALDyadic 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.
OTHEREnhanced 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.
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women * 18 years and older * between 12 and 30 weeks gestation * Score greater than or equal to 13 on Edinburgh Depression Scale * Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified * English Speaking
Exclusion criteria
* Substance abuse or dependence in past 3 months * Active suicidal or homicidal ideation * Bipolar disorder, psychotic disorder * unstable medical condition or other medical/obstetrical complication * Evidence of severe intimate partner violence * Ongoing psychosocial or pharmacotherapy for depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edinburgh Depression Scale From Baseline | 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 | Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Dyadic Interpersonal Psychotherapy | Enhanced Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age, Continuous | 26.9 years STANDARD_DEVIATION 5.81 | 26.38 years STANDARD_DEVIATION 5.9 | 26.64 years STANDARD_DEVIATION 5.79 |
| Edinburgh Depression Scale score | 17.81 units on a scale STANDARD_DEVIATION 3.71 | 17.90 units on a scale STANDARD_DEVIATION 4.6 | 17.86 units on a scale STANDARD_DEVIATION 4.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 20 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 16 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | Baseline Score | 17.81 units on a scale | Standard Deviation 3.71 |
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | 37-39 week gestation score | 12.04 units on a scale | Standard Deviation 1.22 |
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | 3-month postpartum score | 11.0 units on a scale | Standard Deviation 6.1 |
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | 6-month postpartum score | 9.5 units on a scale | Standard Deviation 2.9 |
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | 9-month postpartum score | 10.6 units on a scale | Standard Deviation 5.9 |
| Dyadic Interpersonal Psychotherapy | Change in Edinburgh Depression Scale From Baseline | 12-month postpartum score | 10.8 units on a scale | Standard Deviation 4 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | 9-month postpartum score | 9.4 units on a scale | Standard Deviation 4.7 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | Baseline Score | 17.9 units on a scale | Standard Deviation 4.6 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | 6-month postpartum score | 9.4 units on a scale | Standard Deviation 5.8 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | 37-39 week gestation score | 11.41 units on a scale | Standard Deviation 1.72 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | 12-month postpartum score | 8.8 units on a scale | Standard Deviation 4.9 |
| Enhanced Treatment as Usual | Change in Edinburgh Depression Scale From Baseline | 3-month postpartum score | 10.3 units on a scale | Standard Deviation 6.8 |