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
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring mental health, substance use, treatment
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
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
NCT ID
NCT00447733
First Posted
March 14, 2007
Last Updated
March 23, 2012
Sponsor
University of Oslo
Collaborators
SINTEF Health Research
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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