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Psychotic DisordersPhase 1NCT00231933

Culturally Responsive Person-Centered Care for Psychosis

A Phase 1 study testing Person-centered planning (PCP), Community integration (CI) and Illness management recovery (IMR) in people with Psychotic Disorders, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychotic Disorders
What is being tested?
Person-centered planning (PCP), Community integration (CI) and Illness management recovery (IMR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteUnited States
Study dates
Oct 2005to May 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Connecticut Mental Health Center

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Person-centered planning (PCP), Community integration (CI), Illness management recovery (IMR)
Keywords
Person-centered Care, Recovery, Disparities, Culturally Responsive Care, Psychosis
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-centered planning (PCP)Behavioural

    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.

  • Community integration (CI)Behavioural

    CI includes recovery group sessions and community integration activities.

  • Illness management recovery (IMR)Behavioural

    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.

Study groups in NCT00231933
Study groupRoleWhat they receive
1Active comparatorParticipants will receive standard care incorporating illness management recovery
Receives: Behavioral: Illness management recovery (IMR)
2ExperimentalParticipants will receive illness management recovery plus person-centered planning
Receives: Behavioral: Person-centered planning (PCP); Behavioral: Illness management recovery (IMR)
3ExperimentalParticipants will receive illness management recovery plus person-centered planning and community integration
Receives: Behavioral: Person-centered planning (PCP); Behavioral: Community integration (CI); Behavioral: Illness management recovery (IMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychiatric symptoms

    Measured: Measured at Months 6 and 18

  2. Social functioning

    Measured: Measured at Months 6 and 18

  3. Quality of life

    Measured: Measured at Months 6 and 18

  4. Community integration

    Measured: Measured at Months 6 and 18

Secondary outcomes (2)
  1. Collaborative nature of care

    Measured: Measured at Months 6 and 18

  2. Culturally responsive nature of care

    Measured: Measured at Months 6 and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00231933
Sponsor's protocol ID
0502027488
Other IDs
R01MH067687, DSIR 82-SESC
Status last verified
Mar 2020
First submitted
30 Sep 2005
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Person-centered planning (PCP), Community integration (CI) and Illness management recovery (IMR) in people with Psychotic Disorders, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychiatric symptoms (time frame: Measured at Months 6 and 18). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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