Clinical trial NCT01732055: Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
Official title: Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Partner Assisted Interpersonal Psychotherapy
Treatment as Usual
Keywords: Pregnancy
Antenatal
Major Depressive Disorder
Psychotherapy
Antidepressant Medication
Partners
Spouses
Interpersonal Psychotherapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The Foundation of Hope for Research and Treatment of Mental Illness
First posted: 2012-11-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression-17 item version (HRSD-17)
timeFrame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Secondary outcomes:
measure: Dyadic Adjustment Scale (DAS)
timeFrame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals and Clinics
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Anna R. Brandon, PhD, MSCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Samantha Meltzer-Brody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.