- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00231933
Culturally Responsive Person-Centered Care for Psychosis
Culturally-responsive, Person-centered Care for Psychosis
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Participants will receive standard care incorporating illness management recovery
|
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.
|
|
Experimental: 2
Participants will receive illness management recovery plus person-centered planning
|
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.
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.
|
|
Experimental: 3
Participants will receive illness management recovery plus person-centered planning and community integration
|
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.
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.
CI includes recovery group sessions and community integration activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Psychiatric symptoms
Time Frame: Measured at Months 6 and 18
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Measured at Months 6 and 18
|
|
Social functioning
Time Frame: Measured at Months 6 and 18
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Measured at Months 6 and 18
|
|
Quality of life
Time Frame: Measured at Months 6 and 18
|
Measured at Months 6 and 18
|
|
Community integration
Time Frame: Measured at Months 6 and 18
|
Measured at Months 6 and 18
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collaborative nature of care
Time Frame: Measured at Months 6 and 18
|
Measured at Months 6 and 18
|
|
Culturally responsive nature of care
Time Frame: Measured at Months 6 and 18
|
Measured at Months 6 and 18
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Larry Davidson, PhD, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0502027488
- DSIR 82-SESC
- R01MH067687 (U.S. NIH Grant/Contract)
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