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Completed

NCT Number: NCT00307216

Graduated Recovery Intervention Program for Enhancing Treatment 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.

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Key information

Conditions

Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals OASIS Program for Early Psychosis

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graduated Recovery Intervention Program (GRIP)

Behavioral

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)

Behavioral

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

Primary outcomes

  1. Role Functioning Scale

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  2. Heinrichs-Carpenter Quality of Life Scale (QLS)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  3. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  4. Global Functioning Scale

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

Secondary outcomes

  1. Brief Evaluation of Medication Influences and Beliefs

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  2. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  3. Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  4. Brief Trauma Questionnaire (BTQ)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  5. PTSD Checklist (PCL)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  6. Alcohol Use Scale and Drug Use Scale (AUS/DUS)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  7. Number of hospital admissions

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  8. Ambiguous Intentions Hostility Questionnaire (AIHQ)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  9. Goal attainment ratings

    Time frame: Measured at post-test

  10. Scales of Wellbeing

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  11. Social Skills Performance Assessment (SSPA)

    Time frame: Measured at baseline, post-test, and Month 3 follow-up

  12. Treatment Compliance Scale (TCS)

    Time frame: Measured at post-test

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2006
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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