Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

NCT00804739 | Completed DMC

• 1 other identifier: 1R34MH082141-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to test whether a new model of collaborative care depression treatment adapted to the needs and preferences of low-income, urban mothers with perinatal depression and to a pediatric clinic setting increases engagement in and adherence to perinatal depression treatment.

Conditions

Postpartum Depression

Keywords

Major Depression; Postpartum Depression; Perinatal Depression; Treatment Feasibility; Treatment Engagement; Treatment Adherence; Postpartum; Interpersonal Psychotherapy; IPT; Sertraline; Zoloft

Outcome Measures

Primary Outcomes (2)

• Treatment Engagement

  6 weeks

• Treatment Adherence

  18 weeks

Secondary Outcomes (5)

• Treatment Response

  12 weeks

• Treatment Remission

  12 weeks

• Maternal functional assessment

  12 weeks

• Maternal healthcare utilization

  18 weeks

• Infant healthcare utilization

  18 weeks

Study Arms (1)

MITT

EXPERIMENTAL

Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach.

Other: Mother-Infant Treatment Team

Interventions

Mother-Infant Treatment Team OTHER

This is a treatment team approach that allows for outreach. The clinical team will be a nurse practitioner of psychiatry and a social worker. The nurse practitioner will provide either interpersonal psychotherapy, sertraline or both as indicated.

MITT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers of infants 12 months of age or younger who present to the Pediatric Practice at Golisano Children's Hospital
• Women who are 18 years of age or older
• Mothers who understand and speak English sufficiently to participate in therapy with an English speaking provider
• Have a current score of \> 10 on the EPDS
• Provide written informed consent
• Meet criteria for unipolar major depressive disorder.

You may not qualify if:

• Women who:
• do not speak or understand English well enough to participate in the therapy with an English speaking provider
• are under 18 years of age
• children are not cared for at the Pediatric Practice at the Golisano Children's Hospital
• are actively psychotic, suicidal or homicidal,
• require treatment (including additional psychotropic medications) not provided by MITT,
• in the judgment of the MITT psychiatric provider require a higher level of psychiatric care (i.e. partial hospitalization, hospitalization, intensive case management),
• are in active counseling or psychotherapy,
• are under the care of a psychiatric provider and/or are receiving active treatment for depression including light therapy, ECT, or antidepressants
• are receiving psychotropic medications not allowed in this study,
• previously participated in and/or were terminated from the study,
• have a diagnosis of bipolar disorder, schizophrenia, other psychotic disorder or alcohol/substance use disorder, and/or
• have a medical condition or are taking medications that are contraindicated for sertraline

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depressive Disorder, Major; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Linda H Chaudron, MD, MS

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 27, 2012

Record last verified: 2012-02

Locations

US (1)