Culturally Responsive Person-Centered Care for Psychosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Larry Davidson, Yale University
ClinicalTrials.gov Identifier:
NCT00231933
First received: September 30, 2005
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Psychotic Disorders
Behavioral: Person-centered planning (PCP)
Behavioral: Community integration (CI)
Behavioral: Illness management recovery (IMR)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally-responsive, Person-centered Care for Psychosis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Psychiatric symptoms [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]
  • Community integration [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collaborative nature of care [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]
  • Culturally responsive nature of care [ Time Frame: Measured at Months 6 and 18 ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: October 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive standard care incorporating illness management recovery
Behavioral: Illness management recovery (IMR)
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
Behavioral: Person-centered planning (PCP)
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.
Behavioral: Illness management recovery (IMR)
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: 3
Participants will receive illness management recovery plus person-centered planning and community integration
Behavioral: Person-centered planning (PCP)
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.
Behavioral: Community integration (CI)
CI includes recovery group sessions and community integration activities.
Behavioral: Illness management recovery (IMR)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231933

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Larry Davidson, PhD Yale University
  More Information

No publications provided

Responsible Party: Larry Davidson, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00231933     History of Changes
Other Study ID Numbers: R01 MH67687, R01MH067687, DSIR 82-SESC
Study First Received: September 30, 2005
Last Updated: April 9, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Person-centered Care
Recovery
Disparities
Culturally Responsive Care
Psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 28, 2014