- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00307216
Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- UNC Hospitals OASIS Program for Early Psychosis
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 2
참가자는 평소와 같이 치료를 받게 됩니다.
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Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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실험적: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
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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.
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Role Functioning Scale
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Heinrichs-Carpenter Quality of Life Scale (QLS)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Multidimensional Scale of Perceived Social Support (MSPSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Global Functioning Scale
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Brief Evaluation of Medication Influences and Beliefs
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Positive and Negative Syndrome Scale (PANSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Calgary Depression Scale for Schizophrenia (CDSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Brief Trauma Questionnaire (BTQ)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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PTSD Checklist (PCL)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Alcohol Use Scale and Drug Use Scale (AUS/DUS)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Number of hospital admissions
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Ambiguous Intentions Hostility Questionnaire (AIHQ)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Goal attainment ratings
기간: Measured at post-test
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Measured at post-test
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Scales of Wellbeing
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Social Skills Performance Assessment (SSPA)
기간: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Treatment Compliance Scale (TCS)
기간: Measured at post-test
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Measured at post-test
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공동 작업자 및 조사자
수사관
- 수석 연구원: David L. Penn, PhD, University of North Carolina, Chapel Hill
- 수석 연구원: Diana O. Perkins, MD, University of North Carolina, Chapel Hill
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R34MH071252 (미국 NIH 보조금/계약)
- DATR A2-AISZ (World Health Organization ICTRP)
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