Clinical trial NCT00307216: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Keywords: First Episode Psychosis
Early Psychosis
Psychosocial Intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-03-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Role Functioning Scale
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Heinrichs-Carpenter Quality of Life Scale (QLS)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Global Functioning Scale
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
Secondary outcomes:
measure: Brief Evaluation of Medication Influences and Beliefs
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Brief Trauma Questionnaire (BTQ)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: PTSD Checklist (PCL)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Alcohol Use Scale and Drug Use Scale (AUS/DUS)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Number of hospital admissions
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Ambiguous Intentions Hostility Questionnaire (AIHQ)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Goal attainment ratings
timeFrame: Measured at post-test
measure: Scales of Wellbeing
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Social Skills Performance Assessment (SSPA)
timeFrame: Measured at baseline, post-test, and Month 3 follow-up
measure: Treatment Compliance Scale (TCS)
timeFrame: Measured at post-test
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals OASIS Program for Early Psychosis
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David L. Penn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Diana O. Perkins, MD
role: PRINCIPAL_INVESTIGATOR
References: