NCT00231933

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

September 30, 2005

Last Update Submit

March 31, 2020

Conditions

Keywords

Person-centered CareRecoveryDisparitiesCulturally Responsive CarePsychosis

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

  • Collaborative nature of care

    Measured at Months 6 and 18

  • Culturally responsive nature of care

    Measured at Months 6 and 18

Study Arms (3)

1

ACTIVE COMPARATOR

Participants will receive standard care incorporating illness management recovery

Behavioral: Illness management recovery (IMR)

2

EXPERIMENTAL

Participants will receive illness management recovery plus person-centered planning

Behavioral: Person-centered planning (PCP)Behavioral: Illness management recovery (IMR)

3

EXPERIMENTAL

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

Behavioral: Person-centered planning (PCP)Behavioral: Community integration (CI)Behavioral: Illness management recovery (IMR)

Interventions

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.

23

CI includes recovery group sessions and community integration activities.

3

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.

123

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Larry Davidson, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations