Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression

NCT ID: NCT01732055

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Partner-Assisted Interpersonal Psychotherapy

Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner.

Group Type: ACTIVE_COMPARATOR

Partner-Assisted Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

Treatment as Usual

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

Group Type: OTHER

Treatment as Usual

Intervention Type: 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.

Interventions

Partner-Assisted Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

PA-IPT; PAT; TAU; Watchful Waiting; Antidepressant Medication

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Foundation of Hope for Research and Treatment of Mental Illness

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna R. Brandon, PhD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Samantha Meltzer-Brody, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Hospitals and Clinics

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23053218 (View on PubMed)

Other Identifiers

12-0235

Identifier Type: -

Identifier Source: org_study_id