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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Penn, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00307216
First received: March 23, 2006
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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
Psychotic Disorders
Schizophrenia
Behavioral: Graduated Recovery Intervention Program (GRIP)
Behavioral: Treatment as usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Role Functioning Scale [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Heinrichs-Carpenter Quality of Life Scale (QLS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Global Functioning Scale [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Evaluation of Medication Influences and Beliefs [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Brief Trauma Questionnaire (BTQ) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • PTSD Checklist (PCL) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Alcohol Use Scale and Drug Use Scale (AUS/DUS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Number of hospital admissions [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: Yes ]
  • Ambiguous Intentions Hostility Questionnaire (AIHQ) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Goal attainment ratings [ Time Frame: Measured at post-test ] [ Designated as safety issue: No ]
  • Scales of Wellbeing [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Social Skills Performance Assessment (SSPA) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ]
  • Treatment Compliance Scale (TCS) [ Time Frame: Measured at post-test ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
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.
Active Comparator: 2
Participants will receive treatment as usual
Behavioral: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307216

Locations
United States, North Carolina
UNC Hospitals OASIS Program for Early Psychosis
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David L. Penn, PhD University of North Carolina, Chapel Hill
Principal Investigator: Diana O. Perkins, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: David Penn, PhD, Professor of Psychology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00307216     History of Changes
Other Study ID Numbers: R34 MH071252, R34MH071252, DATR A2-AISZ
Study First Received: March 23, 2006
Last Updated: March 28, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
First Episode Psychosis
Early Psychosis
Psychosocial Intervention

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 15, 2014