Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
|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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression|
|Study Start Date :||November 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
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
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.
- 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
- Dyadic Adjustment Scale (DAS) [ Time Frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum) ]Change from baseline in relationship satisfaction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732055
|United States, North Carolina|
|University of North Carolina Hospitals and Clinics|
|Chapel Hill, North Carolina, United States, 27599-7160|
|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|