Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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:
  • TAU
  • Watchful Waiting
  • Antidepressant Medication


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Dyadic Adjustment Scale (DAS) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ]
    Change from baseline in relationship satisfaction


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732055


Locations
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01732055    
Other Study ID Numbers: 12-0235
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
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:
Layout table for MeSH terms
Depression
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs