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

2013년 3월 28일 업데이트: David Penn, PhD, University of North Carolina, Chapel Hill

Randomized Controlled Trial of the Graduated Recovery Intervention Program 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.

연구 개요

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

중재적

등록 (실제)

46

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • UNC Hospitals OASIS Program for Early Psychosis

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

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

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 2
참가자는 평소와 같이 치료를 받게 됩니다.
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
실험적: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Role Functioning Scale
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Heinrichs-Carpenter Quality of Life Scale (QLS)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up

2차 결과 측정

결과 측정
기간
Brief Evaluation of Medication Influences and Beliefs
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Positive and Negative Syndrome Scale (PANSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Calgary Depression Scale for Schizophrenia (CDSS)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings
기간: Measured at post-test
Measured at post-test
Scales of Wellbeing
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Social Skills Performance Assessment (SSPA)
기간: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)
기간: Measured at post-test
Measured at post-test

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

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

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 4월 1일

기본 완료 (실제)

2008년 12월 1일

연구 완료 (실제)

2008년 12월 1일

연구 등록 날짜

최초 제출

2006년 3월 23일

QC 기준을 충족하는 최초 제출

2006년 3월 23일

처음 게시됨 (추정)

2006년 3월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 3월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 3월 28일

마지막으로 확인됨

2013년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R34MH071252 (미국 NIH 보조금/계약)
  • DATR A2-AISZ (World Health Organization ICTRP)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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