Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase (MITT)

Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Other: Mother-Infant Treatment Team

Detailed Description

This research project consists of two phases that are designed, in sequence, to adapt standard collaborative care depression treatment to the unique needs of low-income depressed postpartum women and to the pediatric setting where women will receive the treatment. These adaptations, in turn, are designed to improve maternal engagement in and adherence to depression treatment, the primary outcomes at this early stage of intervention development. Phase I is the initial pilot project in which the model will be developed. We will 1) adapt standard collaborative care depression models into the Mother-Infant Treatment Team (MITT) intervention and develop a procedure manual based on maternal and provider input, 2) pilot the MITT intervention with 10 depressed mothers to test the feasibility of implementing the model, and 3) evaluate the experiences of participating mothers and providers to revise and finalize MITT processes and procedures.

Phase II will be an open label trial of MITT to determine whether MITT is associated with improved maternal engagement and adherence to depression treatment.

We will pilot MITT with 10 mothers to determine the feasibility of implementing MITT. We will collect recruitment and logistical feasibility measures. We will also determine engagement and adherence rates to treatment as well as the effort required to engage women in treatment.

We will determine mothers' and providers' perceptions of their experiences with MITT and will use all of this information to revise the MITT protocol in preparation for Phase II.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

Women who:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MITT; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment Engagement	6 weeks
Treatment Adherence	18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment Response	12 weeks
Treatment Remission	12 weeks
Maternal functional assessment	12 weeks
Maternal healthcare utilization	18 weeks
Infant healthcare utilization	18 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Linda H Chaudron, MD, MS, University of Rochester

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: December 8, 2008
• First Posted (Estimate): December 9, 2008

Study Record Updates

• Last Update Posted (Estimate): February 27, 2012
• Last Update Submitted That Met QC Criteria: February 23, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Postpartum Depression; Postpartum; Major Depression; Sertraline; Perinatal Depression; Treatment Feasibility; Treatment Engagement; Treatment Adherence; Interpersonal Psychotherapy; IPT; Zoloft
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 1R34MH082141-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No