Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Treatment as Usual Clinical Trial

Official title:

Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01732055
• Other study ID #: 12-0235
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 6, 2012
• Last updated: January 13, 2014
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partner Assisted Interpersonal Psychotherapy
• Treatment as Usual

Intervention

Behavioral:
• Partner-Assisted Interpersonal Psychotherapy

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.

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals and Clinics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	The Foundation of Hope for Research and Treatment of Mental Illness

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression-17 item version (HRSD-17)	Change from baseline in symptoms of Major Depressive Disorder	Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)	Yes
Secondary	Dyadic Adjustment Scale (DAS)	Change from baseline in relationship satisfaction	Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)	No