Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
Status and phase
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Treatments
Details and patient eligibility
About
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program.
Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners.
Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.
Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Females aged 18-45 years
- 16-29 weeks estimated gestational age
- Able to provide informed consent
- English or Spanish language literacy
- In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment Scale rating < 90 or with an identified family member or friend residing in the same home
- Meet criteria for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition Text Revision (DSM-IV) diagnosis of Major Depressive Disorder (MDD)
- HRSD-17 score is equal or greater than 16 at diagnostic evaluation and randomization
- Medically healthy and without fetal anomaly according to history
Exclusion criteria
- No identified primary care, nurse midwife, or obstetrical physician to monitor pregnancy; participant or physician refuses to sign release of information
- By patient report, history of partner verbal, emotional, or physical abuse
- Partner unable or unwilling to participate
- DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- Substance abuse within the last 6 months
- Eating Disorder
- Current use of other therapies for depression including individual psychotherapy, herbal remedies or other complementary/alternative therapies, antidepressant medication outside the study protocol
- Active suicidal ideation
- Identified partner has DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- Interpersonal violence or abuse
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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