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Culturally Responsive Person-Centered Care for Psychosis

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Person-centered planning (PCP)
Community integration (CI)
Illness management recovery (IMR)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Person-centered Care, Recovery, Disparities, Culturally Responsive Care, Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Of Hispanic and/or African origin DSM-IV diagnosis of an axis I psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features) Exclusion Criteria: N/A

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Participants will receive standard care incorporating illness management recovery

Participants will receive illness management recovery plus person-centered planning

Participants will receive illness management recovery plus person-centered planning and community integration

Outcomes

Primary Outcome Measures

Psychiatric symptoms
Social functioning
Quality of life
Community integration

Secondary Outcome Measures

Collaborative nature of care
Culturally responsive nature of care

Full Information

First Posted
September 30, 2005
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00231933
Brief Title
Culturally Responsive Person-Centered Care for Psychosis
Official Title
Culturally-responsive, Person-centered Care for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare standard individualized care to person-centered care and community-integrating care for treating psychosis in adults of Hispanic or African descent.
Detailed Description
Patient-centered care is a type of customized mental health care that is based on each individual's needs, values, and preferences. This type of care has become increasingly important, especially for members of ethnic minorities. However, although this type of care is, in theory, more effective than standard, less personalized care in treating psychotic disorders, there is a significant gap between theory and practice. Research has shown that this gap is particularly evident in the treatment of psychotic disorders in individuals of ethnic backgrounds. This study will address these disparities by comparing the effectiveness of standard individualized care versus person-centered care and community-integrating care in treating psychosis in adults of Hispanic and African descents. This open-label study will consist of two phases. In Phase I, interview data on self-management of mental illness and treatment seeking behaviors will be collected and analyzed. In Phase II, participants from two urban mental health centers will be randomly assigned to receive one of three treatment combinations: standard care incorporating illness management recovery (IMR); IMR plus person-centered planning (PCP); or IMR plus PCP and community integration (CI). IMR will focus on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs. PCP will aid participants in discovering a vision of a desirable future and developing a plan for achieving that goal. Techniques will include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of setbacks as part of the path to success. CI will include recovery group sessions and community integration activities. Recovery groups will consist of 10 to 12 people per group, and will aid participants in asserting the skills they learned in IMR and PCP. Community integration activities will entail a variety of excursions and social and recreational activities in the community to promote community involvement and acquisition of social roles. All treatments will last a total of 6 months. Assessments of psychiatric symptoms, social functioning, quality of life, and community integration will occur at Month 6 and at a follow-up visit at Month 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Person-centered Care, Recovery, Disparities, Culturally Responsive Care, Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive standard care incorporating illness management recovery
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive illness management recovery plus person-centered planning
Arm Title
3
Arm Type
Experimental
Arm Description
Participants will receive illness management recovery plus person-centered planning and community integration
Intervention Type
Behavioral
Intervention Name(s)
Person-centered planning (PCP)
Intervention Description
PCP aids participants in discovering a vision of a desirable future and developing a plan for achieving that goal. Techniques include providing direction in the planning process, involving significant others, generating focus on assets and capacities, identifying and providing access to integrated community settings, and promoting acceptance of set backs as part of the path to success.
Intervention Type
Behavioral
Intervention Name(s)
Community integration (CI)
Intervention Description
CI includes recovery group sessions and community integration activities.
Intervention Type
Behavioral
Intervention Name(s)
Illness management recovery (IMR)
Intervention Description
IMR focuses on nine topic areas: recovery strategies; facts about psychosis; a stress-vulnerability model; building social support; reducing relapses; effective use of medications; coping with stress; coping with problems or symptoms; and meeting health care needs.
Primary Outcome Measure Information:
Title
Psychiatric symptoms
Time Frame
Measured at Months 6 and 18
Title
Social functioning
Time Frame
Measured at Months 6 and 18
Title
Quality of life
Time Frame
Measured at Months 6 and 18
Title
Community integration
Time Frame
Measured at Months 6 and 18
Secondary Outcome Measure Information:
Title
Collaborative nature of care
Time Frame
Measured at Months 6 and 18
Title
Culturally responsive nature of care
Time Frame
Measured at Months 6 and 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Of Hispanic and/or African origin DSM-IV diagnosis of an axis I psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features) Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Davidson, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Culturally Responsive Person-Centered Care for Psychosis

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