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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00447733
Other study ID # 78i068
Secondary ID NFR175394/V50
Status Completed
Phase N/A
First received March 14, 2007
Last updated March 23, 2012
Start date March 2007
Est. completion date December 2010

Study information

Verified date March 2012
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
Treatment as usual
Non-standardized psychiatric outpatient treatment

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Oslo SINTEF Health Research

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Change during 6 and 12 months follow-up No
Secondary 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. Change during 6 and 12 months follow up No
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