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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH071252 | U.S. NIH Grant/Contract | View source | |
| DATR A2-AISZ |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive Graduated Recovery Intervention Program plus treatment as usual |
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| 2 | Active Comparator | Participants will receive treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L. Penn, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Diana O. Perkins, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals OASIS Program for Early Psychosis | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual (TAU) | Behavioral | Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. |
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| 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 |