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

This study has been completed.
Sponsor:
Collaborator:
SINTEF Health Research
Information provided by (Responsible Party):
Rolf W. Grawe, University of Oslo
ClinicalTrials.gov Identifier:
NCT00447733
First received: March 14, 2007
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Anxiety Disorders
Mood Disorders
Substance Use Disorders
Behavioral: Integrated mental health and substance use treatment
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT). [ Time Frame: Change during 6 and 12 months follow-up ] [ Designated as safety issue: No ]

    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) [ Time Frame: Change during 6 and 12 months follow up ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Integrated mental health and substance use treatment
Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
Other Names:
  • dual disorder treatment
  • co-occurring disorders
Active Comparator: Treatment as usual
Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.
Behavioral: Treatment as usual
Non-standardized psychiatric outpatient treatment
Other Names:
  • TAU
  • non-manualized

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447733

Sponsors and Collaborators
University of Oslo
SINTEF Health Research
Investigators
Principal Investigator: Rolf W. Gråwe, Ph.D Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
  More Information

Additional Information:
No publications provided by University of Oslo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rolf W. Grawe, Ph.d.; Assistent Professor; University of Oslo, University of Oslo
ClinicalTrials.gov Identifier: NCT00447733     History of Changes
Other Study ID Numbers: 78i068, NFR175394/V50
Study First Received: March 14, 2007
Last Updated: March 23, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Oslo:
mental health
substance use
treatment

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Mood Disorders
Psychotic Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014