Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Phase 1

Terminated

• Conditions: Partner Assisted Interpersonal Psychotherapy; Treatment as Usual
• Interventions: Behavioral: Partner-Assisted Interpersonal Psychotherapy; Other: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partner-Assisted Interpersonal Psychotherapy	Partner-Assisted Interpersonal Psychotherapy	Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner.
Treatment as Usual	Treatment as Usual	Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.

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