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
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|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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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|
|Responsible Party:||Linda Chaudron, Associate Professor, Department of Psychiatry, University of Rochester|
|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|