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Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase (MITT)
This study is not yet open for participant recruitment.
Verified by University of Rochester, December 2008
Sponsors and Collaborators: University of Rochester
National Institute of Mental Health (NIMH)
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00804739
  Purpose

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
Postpartum Depression
 Other: Mother-Infant Treatment Team

MedlinePlus related topics: Depression Postpartum Depression
Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
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

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Treatment Engagement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Treatment Adherence [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Treatment Remission [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maternal functional assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maternal healthcare utilization [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Infant healthcare utilization [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

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
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.
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.

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 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804739

Contacts
Contact: Holly I Wadkins, MA 585-275-9583 holly_wadkins@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Linda H Chaudron, MD, MS University of Rochester
  More Information

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

Keywords provided by University of Rochester:
Major Depression
Postpartum Depression
Perinatal Depression
Treatment Feasibility
Treatment Engagement
Treatment Adherence
 Postpartum
Interpersonal Psychotherapy
IPT
Sertraline
Zoloft

Study placed in the following topic categories:
Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum
Mental Disorders
 Mood Disorders
Sertraline
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 10, 2009



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