NCT02723058

Brief Summary

The purpose of this study is to pilot test an adapted collaborative care model for homeless mothers with depression.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 21, 2016

Last Update Submit

March 24, 2016

Conditions

Keywords

DepressionHomelessnessPrimary care

Outcome Measures

Primary Outcomes (1)

  • Change in The Hopkins Depression Symptom Checklist -Depression Scale 20 (Williams et al, 2004)

    The primary end point is 6 months

Secondary Outcomes (4)

  • Number of visits to the care manager and primary care physician

    The primary end point is 6 months

  • New antidepressant medication prescriptions

    The primary end point is 6 months

  • Patient Reactions Assessment (Galassi et al, 1992)

    The primary end point is 6 months

  • Helping Alliance Questionnaire (Luborsky et al, 1985)

    The primary end point is 6 months

Study Arms (2)

ICMHM

EXPERIMENTAL

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.

Behavioral: ICMHM

Treatment as Usual

NO INTERVENTION

Treatment as Usual mothers receive usual services of a PCP and case manager from a shelter-based primary care clinic. .

Interventions

ICMHMBEHAVIORAL

ICMHM participants receive a collaborative care model adapted to include an engagement interview, attention to co-morbid conditions, and attention to basic needs.

ICMHM

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers who are residing in emergency shelter
  • years of age or older
  • Screen positive for depression
  • Speak English or Spanish

You may not qualify if:

  • Not pregnant
  • Not currently receiving depression treatment
  • Not currently psychotic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Weinreb L, Upshur CC, Fletcher-Blake D, Reed G, Frisard C. Managing Depression Among Homeless Mothers: Pilot Testing an Adapted Collaborative Care Intervention. Prim Care Companion CNS Disord. 2016 Apr 21;18(2):10.4088/PCC.15m01907. doi: 10.4088/PCC.15m01907. eCollection 2016.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice chair and professor, Family Medicine and Community Health

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 30, 2016

Study Start

December 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2013

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share