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Sponsors and Collaborators: |
University of Rochester National Institute of Mental Health (NIMH) |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00804739 |
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 | Intervention |
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Postpartum Depression |
Other: Mother-Infant Treatment Team |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label, Single Group Assignment |
Official Title: | Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase |
Estimated Enrollment: | 15 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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MITT: Experimental
Mothers will be assigned to the Mother-Infant Treatment Team and will receive either psychotherapy or sertraline or both as well as outreach.
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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.
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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 a pilot randomized controlled trial comparing MITT to enhanced referral as usual (ERAU) 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.
PHASE II: We will pilot a randomized controlled trial (RCT) to test whether MITT results in greater engagement in and adherence to depression treatment than enhanced referral as usual (ERAU)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Women who:
Contact: Holly I Wadkins, MA | 585-275-9583 | holly_wadkins@urmc.rochester.edu |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Linda H Chaudron, MD, MS | University of Rochester |
Responsible Party: | University of Rochester ( Linda Chaudron, MD, MS - Principal Investigator ) |
Study ID Numbers: | 1R34 MH082141-01 |
Study First Received: | December 8, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00804739 |
Health Authority: | United States: Institutional Review Board |
Major Depression Postpartum Depression Perinatal Depression Treatment Feasibility Treatment Engagement Treatment Adherence |
Postpartum Interpersonal Psychotherapy IPT Sertraline Zoloft |
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum Mental Disorders |
Mood Disorders Sertraline Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |