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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00307216
Enrollment
46
Registered
2006-03-27
Start date
2006-04-30
Completion date
2008-12-31
Last updated
2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders, Schizophrenia

Keywords

First Episode Psychosis, Early Psychosis, Psychosocial Intervention

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.

Interventions

BEHAVIORALGraduated 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.

BEHAVIORALTreatment as usual (TAU)

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Role Functioning ScaleMeasured 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 ScaleMeasured at baseline, post-test, and Month 3 follow-up

Secondary

MeasureTime frame
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 admissionsMeasured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)Measured at baseline, post-test, and Month 3 follow-up
Brief Evaluation of Medication Influences and BeliefsMeasured at baseline, post-test, and Month 3 follow-up
Scales of WellbeingMeasured 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
Goal attainment ratingsMeasured at post-test
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026