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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Behavioral: Graduated Recovery Intervention Program (GRIP); Behavioral: Treatment as usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals OASIS Program for Early Psychosis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Role Functioning Scale	Measured at baseline, post-test, and Month 3 follow-up
Heinrichs-Carpenter Quality of Life Scale (QLS)	Measured at baseline, post-test, and Month 3 follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)	Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale	Measured at baseline, post-test, and Month 3 follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Brief Evaluation of Medication Influences and Beliefs	Measured at baseline, post-test, and Month 3 follow-up
Positive and Negative Syndrome Scale (PANSS)	Measured at baseline, post-test, and Month 3 follow-up
Calgary Depression Scale for Schizophrenia (CDSS)	Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)	Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)	Measured at baseline, post-test, and Month 3 follow-up
Alcohol Use Scale and Drug Use Scale (AUS/DUS)	Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions	Measured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)	Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings	Measured at post-test
Scales of Wellbeing	Measured at baseline, post-test, and Month 3 follow-up
Social Skills Performance Assessment (SSPA)	Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)	Measured at post-test

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• 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

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: March 23, 2006
• First Submitted That Met QC Criteria: March 23, 2006
• First Posted (Estimate): March 27, 2006

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Psychosocial Intervention; First Episode Psychosis; Early Psychosis
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: R34MH071252 (U.S. NIH Grant/Contract); DATR A2-AISZ (World Health Organization ICTRP)