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Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

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ClinicalTrials.gov Identifier: NCT01732055
Recruitment Status : Terminated (Study ended because recruitment goals unmet and further funding unlikely)
First Posted : November 22, 2012
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
The Foundation of Hope for Research and Treatment of Mental Illness
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE November 6, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2012)
Hamilton Rating Scale for Depression-17 item version (HRSD-17) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ]
Change from baseline in symptoms of Major Depressive Disorder
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2012)
Dyadic Adjustment Scale (DAS) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ]
Change from baseline in relationship satisfaction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
Official Title  ICMJE Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Partner Assisted Interpersonal Psychotherapy
  • Treatment as Usual
Intervention  ICMJE
  • Behavioral: Partner-Assisted Interpersonal Psychotherapy
    Other Names:
    • PA-IPT
    • PAT
  • 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:
    • TAU
    • Watchful Waiting
    • Antidepressant Medication
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Partner-Assisted Interpersonal Psychotherapy
  • Treatment as Usual
    Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.
    Intervention: Other: Treatment as Usual
Publications * Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2012)
104
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732055
Other Study ID Numbers  ICMJE 12-0235
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE The Foundation of Hope for Research and Treatment of Mental Illness
Investigators  ICMJE
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
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP