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
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression||Other: Mother-Infant Treatment Team||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
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.
- Treatment Engagement [ Time Frame: 6 weeks ]
- Treatment Adherence [ Time Frame: 18 weeks ]
- Treatment Response [ Time Frame: 12 weeks ]
- Treatment Remission [ Time Frame: 12 weeks ]
- Maternal functional assessment [ Time Frame: 12 weeks ]
- Maternal healthcare utilization [ Time Frame: 18 weeks ]
- Infant healthcare utilization [ Time Frame: 18 weeks ]
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
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Linda H Chaudron, MD, MS||University of Rochester|