- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723058
The Integrated Care Model for Homeless Mothers (ICMHM)
March 24, 2016 updated by: Linda Weinreb, University of Massachusetts, Worcester
The purpose of this study is to pilot test an adapted collaborative care model for homeless mothers with depression.
Study Overview
Detailed Description
Homeless mothers are more vulnerable to Major Depressive Disorder (MDD) than comparable groups of impoverished mothers, with rates in recent community studies approaching 50%.
Even though primary care offers an ideal venue to identify and manage depression among women who commonly fail to receive needed mental health services, rigorously tested primary care-based treatment strategies that address the needs of homeless mothers with depression are lacking.
This study reports results on a pilot test and feasibility findings of a new intervention, the Integrated Care Model for Homeless Mothers (ICMHM), adapted from the collaborative care model for depression (CCM) to address unique aspects of care for homeless mothers who screened positive for depression during a shelter-based primary care visit.
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers who are residing in emergency shelter
- 18 years of age or older
- Screen positive for depression
- Speak English or Spanish
Exclusion Criteria:
- Not pregnant
- Not currently receiving depression treatment
- Not currently psychotic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICMHM
ICMHM mothers receive services of a primary care clinician (PCP) and a care manager both trained in depression care management in a shelter-based primary care clinic.
|
ICMHM participants receive a collaborative care model adapted to include an engagement interview, attention to co-morbid conditions, and attention to basic needs.
|
No Intervention: Treatment as Usual
Treatment as Usual mothers receive usual services of a PCP and case manager from a shelter-based primary care clinic. .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in The Hopkins Depression Symptom Checklist -Depression Scale 20 (Williams et al, 2004)
Time Frame: The primary end point is 6 months
|
The primary end point is 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of visits to the care manager and primary care physician
Time Frame: The primary end point is 6 months
|
Visits documented between study entry and six months recorded from EMR
|
The primary end point is 6 months
|
New antidepressant medication prescriptions
Time Frame: The primary end point is 6 months
|
Documentation of new antidepressant medication prescriptions between study entry and six months recorded in EMR
|
The primary end point is 6 months
|
Patient Reactions Assessment (Galassi et al, 1992)
Time Frame: The primary end point is 6 months
|
The primary end point is 6 months
|
|
Helping Alliance Questionnaire (Luborsky et al, 1985)
Time Frame: The primary end point is 6 months
|
The primary end point is 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 21, 2016
First Submitted That Met QC Criteria
March 24, 2016
First Posted (Estimate)
March 30, 2016
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 24, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH085881 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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