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

March 14, 2007
March 23, 2012
March 2007
December 2010   (final data collection date for primary outcome measure)
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.

  • alcohol and drug use at baseline, six and twelve months
  • Psychopathology at baseline, six and twelve months
  • Global functioning at baseline, six and twelve months
Complete list of historical versions of study NCT00447733 on ClinicalTrials.gov Archive Site
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.
  • Quality of life at baseline, six and twelve months
  • Therapist alliance at six and twelve months
  • Treatment fidelity at six and twelve months
Not Provided
Not Provided
 
Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anxiety Disorders
  • Mood Disorders
  • Substance Use Disorders
  • 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
  • Behavioral: Treatment as usual
    Non-standardized psychiatric outpatient treatment
    Other Names:
    • TAU
    • non-manualized
  • 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.
    Intervention: Behavioral: Integrated mental health and substance use treatment
  • Active Comparator: Treatment as usual
    Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.
    Intervention: Behavioral: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00447733
78i068, NFR175394/V50
Yes
Rolf W. Grawe, University of Oslo
University of Oslo
SINTEF Health Research
Principal Investigator: Rolf W. Gråwe, Ph.D Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
University of Oslo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP