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Evaluation of Person-Centered Care With and Without Community Integration for Treating Psychosis in Adults of Hispanic and African Descent
This study is ongoing, but not recruiting participants.
Study NCT00231933   Information provided by National Institute of Mental Health (NIMH)
First Received: September 30, 2005   Last Updated: August 22, 2008   History of Changes

September 30, 2005
August 22, 2008
October 2005
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Psychiatric symptoms; measured at Months 6 and 18
  • Social functioning; measured at Months 6 and 18
  • Quality of life; measured at Months 6 and 18
  • Community integration; measured at Months 6 and 18
Complete list of historical versions of study NCT00231933 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Collaborative nature of care; measured at Months 6 and 18
  • Culturally responsive nature of care; measured at Months 6 and 18
 
Evaluation of Person-Centered Care With and Without Community Integration for Treating Psychosis in Adults of Hispanic and African Descent
Culturally-Responsive, Person-Centered Care for Psychosis

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.

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.

Phase I
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Psychotic Disorders
  • Behavioral: Person-centered planning (PCP)
  • Behavioral: Community integration (CI)
  • Behavioral: Illness management recovery (IMR)
  • Active Comparator: Participants will receive standard care incorporating illness management recovery
  • Experimental: Participants will receive illness management recovery plus person-centered planning
  • Experimental: Participants will receive illness management recovery plus person-centered planning and community integration
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
360
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231933
Larry Davidson, PhD, Associate Professor, Yale University School of Medicine
R01 MH67687, DSIR 82-SESC
National Institute of Mental Health (NIMH)
 
Principal Investigator: Larry Davidson, PhD Yale University
National Institute of Mental Health (NIMH)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP