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Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders (ROP)

Primary Purpose

Anxiety Disorders, Mood Disorders, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated mental health and substance use treatment
Treatment as usual
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring mental health, substance use, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Integrated treatment

    Treatment as usual

    Arm Description

    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.

    Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.

    Outcomes

    Primary Outcome Measures

    The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT).
    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.

    Secondary Outcome Measures

    The Addiction Severity Index (Europ ASI)
    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.

    Full Information

    First Posted
    March 14, 2007
    Last Updated
    March 23, 2012
    Sponsor
    University of Oslo
    Collaborators
    SINTEF Health Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00447733
    Brief Title
    Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
    Acronym
    ROP
    Official Title
    Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo
    Collaborators
    SINTEF Health Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Integrated Treatment is effective in the treatment of anxiety and/or depression with co-occurring substance use disorders.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Mood Disorders, Substance Use Disorders
    Keywords
    mental health, substance use, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Integrated treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as usual
    Arm Type
    Active Comparator
    Arm Description
    Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Integrated mental health and substance use treatment
    Other Intervention Name(s)
    dual disorder treatment, co-occurring disorders
    Intervention Description
    Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual
    Other Intervention Name(s)
    TAU, non-manualized
    Intervention Description
    Non-standardized psychiatric outpatient treatment
    Primary Outcome Measure Information:
    Title
    The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT).
    Description
    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.
    Time Frame
    Change during 6 and 12 months follow-up
    Secondary Outcome Measure Information:
    Title
    The Addiction Severity Index (Europ ASI)
    Description
    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.
    Time Frame
    Change during 6 and 12 months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rolf W. Gråwe, Ph.D
    Organizational Affiliation
    Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24597469
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    22933843
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders

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