Clinical trial NCT00804739: Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase
Official title: Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Major Depression
Postpartum Depression
Perinatal Depression
Treatment Feasibility
Treatment Engagement
Treatment Adherence
Postpartum
Interpersonal Psychotherapy
IPT
Sertraline
Zoloft
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-12-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Treatment Engagement
timeFrame: 6 weeks
measure: Treatment Adherence
timeFrame: 18 weeks
Secondary outcomes:
measure: Treatment Response
timeFrame: 12 weeks
measure: Treatment Remission
timeFrame: 12 weeks
measure: Maternal functional assessment
timeFrame: 12 weeks
measure: Maternal healthcare utilization
timeFrame: 18 weeks
measure: Infant healthcare utilization
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Linda H Chaudron, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: