Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Phase 1

Terminated

• Conditions: Partner Assisted Interpersonal Psychotherapy; Treatment as Usual

• Registration Number: NCT01732055
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-17
• Study First Posted: 2012-11-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression-17 item version (HRSD-17)	Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)	Change from baseline in symptoms of Major Depressive Disorder

Secondary Outcome Measures

Name	Time	Method
Dyadic Adjustment Scale (DAS)	Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)	Change from baseline in relationship satisfaction

Trial Locations

Locations (1)

University of North Carolina Hospitals and Clinics; 🇺🇸 Chapel Hill, North Carolina, United States