CClinicalTrials.gg
CompletedNCT00804739MITTUpdated Feb 27, 2012

Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

An interventional study of Mother-Infant Treatment Team in Postpartum Depression, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-27.

Sponsored by University of Rochester · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Depression

Keywords

  • Major Depression
  • Postpartum Depression
  • Perinatal Depression
  • Treatment Feasibility
  • Treatment Engagement
  • Treatment Adherence
  • Postpartum
  • Interpersonal Psychotherapy
  • IPT
  • Sertraline
  • Zoloft
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 30 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • OtherMother-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.

06

What researchers measure

Primary outcomes

  1. Treatment Engagement

    Time frame: 6 weeks

  2. Treatment Adherence

    Time frame: 18 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00804739
Lead sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Linda Chaudron (Associate Professor, Department of Psychiatry, University of Rochester) — Principal investigator
First posted
Dec 9, 2008
Start date
Jan 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Feb 27, 2012

Study contacts

Linda H Chaudron, MD, MS
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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