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

Schizophrenia Clinical Trial

Official title:

Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307216
• Other study ID #: R34MH071252
• Secondary ID: R34MH071252DATR
• Status: Completed
• Phase: N/A
• First received: March 23, 2006
• Last updated: March 28, 2013
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.
• Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Locations

Country	Name	City	State
United States	UNC Hospitals OASIS Program for Early Psychosis	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role Functioning Scale		Measured at baseline, post-test, and Month 3 follow-up	No
Primary	Heinrichs-Carpenter Quality of Life Scale (QLS)		Measured at baseline, post-test, and Month 3 follow-up	No
Primary	Multidimensional Scale of Perceived Social Support (MSPSS)		Measured at baseline, post-test, and Month 3 follow-up	No
Primary	Global Functioning Scale		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Brief Evaluation of Medication Influences and Beliefs		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Positive and Negative Syndrome Scale (PANSS)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Calgary Depression Scale for Schizophrenia (CDSS)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Brief Trauma Questionnaire (BTQ)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	PTSD Checklist (PCL)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Alcohol Use Scale and Drug Use Scale (AUS/DUS)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Number of hospital admissions		Measured at baseline, post-test, and Month 3 follow-up	Yes
Secondary	Ambiguous Intentions Hostility Questionnaire (AIHQ)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Goal attainment ratings		Measured at post-test	No
Secondary	Scales of Wellbeing		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Social Skills Performance Assessment (SSPA)		Measured at baseline, post-test, and Month 3 follow-up	No
Secondary	Treatment Compliance Scale (TCS)		Measured at post-test	No