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

March 23, 2006
March 28, 2013
April 2006
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Measured post-treatment and at the 3-month follow-up: Social Functioning Scale (SFS)
  • Heinrichs-Carpenter Quality of Life Scale (QLS)
  • Multidimensional Scale of Perceived Social Support (MSPSS)
Complete list of historical versions of study NCT00307216 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured post-treatment and at the 3-month follow-up: 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
  • Measure of ego-resilience
Not Provided
Not Provided
 
Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Psychotic Disorders
  • Schizophrenia
  • 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.
  • Experimental: 1
    Participants will receive Graduated Recovery Intervention Program plus treatment as usual
    Interventions:
    • Behavioral: Graduated Recovery Intervention Program (GRIP)
    • Behavioral: Treatment as usual (TAU)
  • Active Comparator: 2
    Participants will receive treatment as usual
    Intervention: Behavioral: Treatment as usual (TAU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00307216
R34 MH071252, R34MH071252, DATR A2-AISZ
Yes
David Penn, PhD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Principal Investigator: David L. Penn, PhD University of North Carolina, Chapel Hill
Principal Investigator: Diana O. Perkins, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP