| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis | ||||||||
| Official Title † | Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis | ||||||||
| 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. |
||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Role Functioning Scale [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Heinrichs-Carpenter Quality of Life Scale (QLS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Global Functioning Scale [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] |
||||||||
| Secondary Outcome Measure † | Brief Evaluation of Medication Influences and Beliefs [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Brief Trauma Questionnaire (BTQ) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] PTSD Checklist (PCL) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Alcohol Use Scale and Drug Use Scale (AUS/DUS) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Number of hospital admissions [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: Yes ] Ambiguous Intentions Hostility Questionnaire (AIHQ) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Goal attainment ratings [ Time Frame: Measured at post-test ] [ Designated as safety issue: No ] Scales of Wellbeing [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Social Skills Performance Assessment (SSPA) [ Time Frame: Measured at baseline, post-test, and Month 3 follow-up ] [ Designated as safety issue: No ] Treatment Compliance Scale (TCS) [ Time Frame: Measured at post-test ] [ Designated as safety issue: No ] |
||||||||
| Condition † | Psychotic Disorders Schizophrenia |
||||||||
| Intervention † | Behavioral: Graduated Recovery Intervention Program (GRIP) Behavioral: Treatment as usual (TAU) |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | April 2006 | ||||||||
| Completion Date | April 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00307216 | ||||||||
| Organization ID | R34 MH71252 | ||||||||
| Secondary IDs †† | DATR A2-AISZ | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | March 23, 2006 | ||||||||
| Last Updated Date | August 27, 2008 | ||||||||
|
