Postpartum DepressionMITTNCT00804739
Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase
A study testing Mother-Infant Treatment Team in people with Postpartum Depression, run by University of Rochester at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Mother-Infant Treatment Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who:
- 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,
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
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.
- Conditions
- Postpartum Depression
- Being tested
- Mother-Infant Treatment Team
- Keywords
- Major Depression, Postpartum Depression, Perinatal Depression, Treatment Feasibility, Treatment Engagement, Treatment Adherence, Postpartum, Interpersonal Psychotherapy, IPT, Sertraline, Zoloft
- Medical subject headings
- Depression, Postpartum, Depressive Disorder, Major, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-Infant Treatment TeamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MITT | Experimental | Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach. Receives: Other: Mother-Infant Treatment Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement
Measured: 6 weeks
Treatment Adherence
Measured: 18 weeks
Secondary outcomes (5)
Treatment Response
Measured: 12 weeks
Treatment Remission
Measured: 12 weeks
Maternal functional assessment
Measured: 12 weeks
Maternal healthcare utilization
Measured: 18 weeks
Infant healthcare utilization
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Linda Chaudron, University of Rochester
- Investigators
- Linda H Chaudron, MD, MS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804739
- Sponsor's protocol ID
- 1R34MH082141-01
- Acronym
- MITT
- Status last verified
- Feb 2012
- First submitted
- 8 Dec 2008
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
- ClinicalTrials.gov ID
- NCT00804739
- Acronym / sponsor ID
- MITT / 1R34MH082141-01
- Conditions
- Postpartum Depression
- Keywords
- Major Depression, Postpartum Depression, Perinatal Depression, Treatment Feasibility, Treatment Engagement, Treatment Adherence, Postpartum, Interpersonal Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MITT | Experimental | Other: Mother-Infant Treatment TeamMothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother-Infant Treatment TeamThis 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. | Other | MITT |
Primary outcome
Treatment Engagement
Time frame: 6 weeks
Treatment Adherence
Time frame: 18 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda H Chaudron, MD, MS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother-Infant Treatment Team in people with Postpartum Depression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Engagement (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.