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Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.
We propose to conduct a clinical trial for first episode psychosis patients not eligible for CMHC services that will compare randomized access to care at CMHC versus the usual procedure of referral to community providers outside CMHC. Patients randomized to access to CMHC services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. This care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. All consenting subjects will undergo research evaluations every six months for up to five years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.
Age
16 - 45 years
Sex
ALL
Healthy Volunteers
No
Connecticut Mental Health Center
New Haven, Connecticut, United States
Start Date
March 1, 2006
Primary Completion Date
August 1, 2013
Completion Date
August 1, 2013
Last Updated
February 8, 2017
120
ACTUAL participants
Cognitive Behavioral Group Therapy
BEHAVIORAL
Cognitive remediation
BEHAVIORAL
Medications
DRUG
MFG
BEHAVIORAL
Assertive case management
BEHAVIORAL
Treatment as Usual in the community
OTHER
Lead Sponsor
Yale University
NCT06939088
NCT02928965
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02307396