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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00307216 |
This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Condition | Intervention |
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Psychotic Disorders Schizophrenia |
Behavioral: Graduated Recovery Intervention Program (GRIP) Behavioral: Treatment as usual (TAU) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis |
Estimated Enrollment: | 50 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
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Behavioral: Graduated Recovery Intervention Program (GRIP)
GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.
Behavioral: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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2: Active Comparator
Participants will receive treatment as usual
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Behavioral: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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Several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. Psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly.
First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. The symptoms can be disturbing and unfamiliar to those who have not previously experienced them. The person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. Psychosis is treatable, however, and most people recover. Standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. GRIP is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. This study will determine the effectiveness of GRIP in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Participants in this study will be randomly assigned to receive either treatment as usual (TAU) or TAU plus GRIP. Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. Assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David L. Penn, PhD | 919-843-7514 | dpenn@email.unc.edu |
United States, North Carolina | |
UNC Hospitals OASIS Program for Early Psychosis | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: David L. Penn, PhD 919-843-7514 dpenn@email.unc.edu | |
Principal Investigator: David L. Penn, PhD |
Principal Investigator: | David L. Penn, PhD | The University of North Carolina, Chapel Hill |
Principal Investigator: | Diana O. Perkins, MD | The University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill ( David L. Penn, PhD ) |
Study ID Numbers: | R34 MH071252, DATR A2-AISZ |
Study First Received: | March 23, 2006 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00307216 History of Changes |
Health Authority: | United States: Federal Government |
First Episode Psychosis Early Psychosis Psychosocial Intervention |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |