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

March 23, 2012 updated by: Rolf W. Grawe, University of Oslo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Addiction Severity Index (Europ ASI)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78i068
  • NFR175394/V50 (Other Grant/Funding Number: The Norwegian Research Council/NFR175394/V50)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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