Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

This study has been terminated.
(Study ended because recruitment goals unmet and further funding unlikely)
Sponsor:
Collaborator:
The Foundation of Hope for Research and Treatment of Mental Illness
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01732055
First received: November 6, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Partner Assisted Interpersonal Psychotherapy
Treatment as Usual
Behavioral: Partner-Assisted Interpersonal Psychotherapy
Other: Treatment as Usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression-17 item version (HRSD-17) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ] [ Designated as safety issue: Yes ]
    Change from baseline in symptoms of Major Depressive Disorder


Secondary Outcome Measures:
  • Dyadic Adjustment Scale (DAS) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ] [ Designated as safety issue: No ]
    Change from baseline in relationship satisfaction


Enrollment: 2
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Partner-Assisted Interpersonal Psychotherapy
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
Other Names:
  • PA-IPT
  • PAT
Treatment as Usual
Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.
Other: Treatment as Usual
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.
Other Names:
  • Treatment as Usual
  • TAU
  • Watchful Waiting
  • Antidepressant Medication

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732055

Locations
United States, North Carolina
University of North Carolina Hospitals and Clinics
Chapel Hill, North Carolina, United States, 27599-7160
Sponsors and Collaborators
University of North Carolina, Chapel Hill
The Foundation of Hope for Research and Treatment of Mental Illness
Investigators
Principal Investigator: Anna R. Brandon, PhD, MSCS University of North Carolina, Chapel Hill
Principal Investigator: Samantha Meltzer-Brody, MD, MPH University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01732055     History of Changes
Other Study ID Numbers: 12-0235
Study First Received: November 6, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Pregnancy
Antenatal
Major Depressive Disorder
Psychotherapy
Antidepressant Medication
Partners
Spouses
Interpersonal Psychotherapy

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014