- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
|
Aktiv komparator: 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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT).
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Addiction Severity Index (Europ ASI)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rolf W. Gråwe, Ph.D, Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 78i068
- NFR175394/V50 (Andet bevillings-/finansieringsnummer: The Norwegian Research Council/NFR175394/V50)
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