Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

NCT01732055 | Terminated Phase 1

• 1 other identifier: 12-0235
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Partner Assisted Interpersonal Psychotherapy; Treatment as Usual

Keywords

Pregnancy; Antenatal; Major Depressive Disorder; Psychotherapy; Antidepressant Medication; Partners; Spouses; Interpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Dyadic Adjustment Scale (DAS)

  Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)

Study Arms (2)

Partner-Assisted Interpersonal Psychotherapy

ACTIVE COMPARATOR

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

OTHER

Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm.

Other: Treatment as Usual

Interventions

Partner-Assisted Interpersonal Psychotherapy BEHAVIORAL

Also known as: PA-IPT, PAT

Partner-Assisted Interpersonal Psychotherapy

Treatment as Usual OTHER

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.

Also known as: TAU, Watchful Waiting, Antidepressant Medication

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 18-45 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• The Foundation of Hope for Research and Treatment of Mental Illness: collaborator

Study Sites (1)

University of North Carolina Hospitals and Clinics

Chapel Hill, North Carolina, 27599-7160, United States

Location

Related 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.

  PMID: 23053218 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics; Watchful Waiting; Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anna R. Brandon, PhD, MSCS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Samantha Meltzer-Brody, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 22, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

US (1)