Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

Postpartum Depression Clinical Trial

— MITT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804739
• Other study ID #: 1R34MH082141-01
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: February 23, 2012
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Engagement		6 weeks	No
Primary	Treatment Adherence		18 weeks	No
Secondary	Treatment Response		12 weeks	No
Secondary	Treatment Remission		12 weeks	No
Secondary	Maternal functional assessment		12 weeks	No
Secondary	Maternal healthcare utilization		18 weeks	No
Secondary	Infant healthcare utilization		18 weeks	No