Back to results

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

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:

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

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

NCT ID

NCT00804739

First Posted

December 8, 2008

Last Updated

February 23, 2012

Sponsor

University of Rochester

Collaborators

National Institute of Mental Health (NIMH)

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

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

Learn more about this trial

Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

We'll reach out to this number within 24 hrs