Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis

NCT ID: NCT00307216

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychotic Disorders Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive Graduated Recovery Intervention Program plus treatment as usual

Group Type EXPERIMENTAL

Graduated Recovery Intervention Program (GRIP)

Intervention Type BEHAVIORAL

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.

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

2

Participants will receive treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Interventions

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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.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
* Has been in treatment for psychosis for less than 3 years
* Clinically stable (based on clinician judgement)
* IQ score greater than 70
* Currently receiving keyworker services at UNC Hospital's OASIS program

Exclusion Criteria

* Organic brain disorder
* Substance-induced psychotic disorder
* Mental retardation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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David Penn, PhD

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David L. Penn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Diana O. Perkins, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC Hospitals OASIS Program for Early Psychosis

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH071252

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A2-AISZ

Identifier Type: -

Identifier Source: secondary_id

R34MH071252

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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