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

Primary Purpose

Psychotic Disorders, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Graduated Recovery Intervention Program (GRIP)
Treatment as usual (TAU)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring First Episode Psychosis, Early Psychosis, Psychosocial Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Hospitals OASIS Program for Early Psychosis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive Graduated Recovery Intervention Program plus treatment as usual

Participants will receive treatment as usual

Outcomes

Primary Outcome Measures

Role Functioning Scale
Heinrichs-Carpenter Quality of Life Scale (QLS)
Multidimensional Scale of Perceived Social Support (MSPSS)
Global Functioning Scale

Secondary Outcome Measures

Brief Evaluation of Medication Influences and Beliefs
Positive and Negative Syndrome Scale (PANSS)
Calgary Depression Scale for Schizophrenia (CDSS)
Brief Trauma Questionnaire (BTQ)
PTSD Checklist (PCL)
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Number of hospital admissions
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Goal attainment ratings
Scales of Wellbeing
Social Skills Performance Assessment (SSPA)
Treatment Compliance Scale (TCS)

Full Information

First Posted
March 23, 2006
Last Updated
March 28, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00307216
Brief Title
Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Official Title
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia
Keywords
First Episode Psychosis, Early Psychosis, Psychosocial Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Graduated Recovery Intervention Program (GRIP)
Intervention Description
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
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
Primary Outcome Measure Information:
Title
Role Functioning Scale
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Heinrichs-Carpenter Quality of Life Scale (QLS)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Global Functioning Scale
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Secondary Outcome Measure Information:
Title
Brief Evaluation of Medication Influences and Beliefs
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Brief Trauma Questionnaire (BTQ)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
PTSD Checklist (PCL)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Number of hospital admissions
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Goal attainment ratings
Time Frame
Measured at post-test
Title
Scales of Wellbeing
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Social Skills Performance Assessment (SSPA)
Time Frame
Measured at baseline, post-test, and Month 3 follow-up
Title
Treatment Compliance Scale (TCS)
Time Frame
Measured at post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L. Penn, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diana O. Perkins, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospitals OASIS Program for Early Psychosis
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

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