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

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ClinicalTrials.gov Identifier: NCT00804739
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : February 27, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linda Chaudron, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Other: Mother-Infant Treatment Team Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Treatment Engagement [ Time Frame: 6 weeks ]
  2. Treatment Adherence [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Treatment Response [ Time Frame: 12 weeks ]
  2. Treatment Remission [ Time Frame: 12 weeks ]
  3. Maternal functional assessment [ Time Frame: 12 weeks ]
  4. Maternal healthcare utilization [ Time Frame: 18 weeks ]
  5. Infant healthcare utilization [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804739

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
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Principal Investigator: Linda H Chaudron, MD, MS University of Rochester
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Responsible Party: Linda Chaudron, Associate Professor, Department of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT00804739    
Other Study ID Numbers: 1R34MH082141-01 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012
Keywords provided by Linda Chaudron, University of Rochester:
Major Depression
Postpartum Depression
Perinatal Depression
Treatment Feasibility
Treatment Engagement
Treatment Adherence
Interpersonal Psychotherapy
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications