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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mother-Infant Treatment Team
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postpartum Depression focused on measuring Major Depression, Postpartum Depression, Perinatal Depression, Treatment Feasibility, Treatment Engagement, Treatment Adherence, Postpartum, Interpersonal Psychotherapy, IPT, Sertraline, Zoloft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MITT

Arm Description

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

Outcomes

Primary Outcome Measures

Treatment Engagement
Treatment Adherence

Secondary Outcome Measures

Treatment Response
Treatment Remission
Maternal functional assessment
Maternal healthcare utilization
Infant healthcare utilization

Full Information

First Posted
December 8, 2008
Last Updated
February 23, 2012
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00804739
Brief Title
Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase
Acronym
MITT
Official Title
Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Major Depression, Postpartum Depression, Perinatal Depression, Treatment Feasibility, Treatment Engagement, Treatment Adherence, Postpartum, Interpersonal Psychotherapy, IPT, Sertraline, Zoloft

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MITT
Arm Type
Experimental
Arm Description
Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach.
Intervention Type
Other
Intervention Name(s)
Mother-Infant Treatment Team
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Engagement
Time Frame
6 weeks
Title
Treatment Adherence
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Treatment Response
Time Frame
12 weeks
Title
Treatment Remission
Time Frame
12 weeks
Title
Maternal functional assessment
Time Frame
12 weeks
Title
Maternal healthcare utilization
Time Frame
18 weeks
Title
Infant healthcare utilization
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda H Chaudron, MD, MS
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

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