- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00447733
Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders (ROP)
Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
연구 개요
상태
상세 설명
Patients with mental disorders and co-occuring substance use disorders are characterized by high suicide rates, high treatment drop-out rates and long-lasting interpersonal, work, school, health and legal problems. Because mental disorders and substance use disorders co-exist and interact, it may be important to provide a treatment that addresses the substance misuse and mental health problems in an integrated and comprehensive way. Additionally, the health services for patients with mental health and substance use disorders are usually provided by different services and health professionals that rarely cooperate or have qualifications on both kinds of disorders. This also calls for an integration of the services on an organizational level. This approach of integrating services and treatment approaches for both diseases in a comprehensive way is called Integrated Treatment. Several studies have shown that Integrated Treatment is effective in treating the comorbidity of severe mental illness and substance use disorders. The over-all aim of this study is to evaluate the effects of evidence-based Integrated Treatment in anxiety and/or depression with co-occurring substance use disorders. The effects of the treatment will be assesses on changes in substance use and psychopathology.
Comparison: patients receiving treatment-as-usual or non-manualized treatment at general mental health outpatients clinics.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- clinical diagnosis of substance use disorder
- clinical diagnosis of anxiety disorders
- clinical diagnosis of nonpsychotic mood disorders
- written consent
- planning to live in the catchment area during the treatment
Exclusion Criteria:
- schizophrenia spectrum disorders
- other psychotic disorders
- mental retardation
- nicotine abuse/dependency only
- prescription drug abuse/dependency only
- planning to move out of the catchment area during the study
- not able to read or write Norwegian
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Integrated treatment
Evidence-based psychosocial and pharmacological treatment of both the substance use disorder and the mental health disorder is provided at the same time and by the same therapists in a comprehensive way.
|
Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
다른 이름들:
|
활성 비교기: Treatment as usual
Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.
|
Non-standardized psychiatric outpatient treatment
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT).
기간: Change during 6 and 12 months follow-up
|
We use the SCL-90r to measure symptoms in regard to anxiety, depression and the General Severity Index. We use the AUDIT and the DUDIT to measure changes in the use of alcohol and illegal drugs respectively. |
Change during 6 and 12 months follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The Addiction Severity Index (Europ ASI)
기간: Change during 6 and 12 months follow up
|
The Addiction Severity Index (Europ ASI) is used to assess changes in the use of alcohol and illegal substances during the course of the trial.
|
Change during 6 and 12 months follow up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rolf W. Gråwe, Ph.D, Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
간행물 및 유용한 링크
일반 간행물
- Wusthoff LE, Waal H, Grawe RW. The effectiveness of integrated treatment in patients with substance use disorders co-occurring with anxiety and/or depression--a group randomized trial. BMC Psychiatry. 2014 Mar 5;14:67. doi: 10.1186/1471-244X-14-67.
- Wusthoff LE, Waal H, Grawe RW. When research meets reality-lessons learned from a pragmatic multisite group-randomized clinical trial on psychosocial interventions in the psychiatric and addiction field. Subst Abuse. 2012;6:95-106. doi: 10.4137/SART.S9245. Epub 2012 Aug 16.
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 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. .