Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Stopped early · Phase 1/Phase 2

Conditions studied: Partner Assisted Interpersonal Psychotherapy, Treatment as Usual

In brief

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.

Key facts

Study ID

NCT01732055

Run by

University of North Carolina, Chapel Hill

People needed

2

Starts

2012-11-01

Expected to finish

2013-12-01

Last updated by the study team

2014-01-14

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina Hospitals and Clinics — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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