Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Study Overview
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Brief Summary
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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.

Official Title
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Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Conditions
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Partner Assisted Interpersonal Psychotherapy, Treatment as Usual

Intervention / Treatment
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* Behavioral: Partner-Assisted Interpersonal Psychotherapy
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partner-Assisted Interpersonal Psychotherapy<br>Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner. | Behavioral: Partner-Assisted Interpersonal Psychotherapy<br> <br> * Other names: PAT;|
| Other: Treatment as Usual<br>Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm. | Other: Treatment as Usual<br>* Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms.<br>* Other names: Antidepressant Medication;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyadic Adjustment Scale (DAS) | Change from baseline in relationship satisfaction | Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Antenatal, Major Depressive Disorder, Psychotherapy, Antidepressant Medication, Partners, Spouses, Interpersonal Psychotherapy