Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00447733
Status:
COMPLETED
Last Update Posted:
2012-03-26
First Post:
2007-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2007-03-14', 'studyFirstSubmitQcDate': '2007-03-14', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT).', 'timeFrame': 'Change during 6 and 12 months follow-up', 'description': 'We use the SCL-90r to measure symptoms in regard to anxiety, depression and the General Severity Index.\n\nWe use the AUDIT and the DUDIT to measure changes in the use of alcohol and illegal drugs respectively.'}], 'secondaryOutcomes': [{'measure': 'The Addiction Severity Index (Europ ASI)', 'timeFrame': 'Change during 6 and 12 months follow up', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mental health', 'substance use', 'treatment'], 'conditions': ['Anxiety Disorders', 'Mood Disorders', 'Substance Use Disorders']}, 'referencesModule': {'references': [{'pmid': '24597469', 'type': 'DERIVED', '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.'}, {'pmid': '22933843', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nComparison: patients receiving treatment-as-usual or non-manualized treatment at general mental health outpatients clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of substance use disorder\n* clinical diagnosis of anxiety disorders\n* clinical diagnosis of nonpsychotic mood disorders\n* written consent\n* planning to live in the catchment area during the treatment\n\nExclusion Criteria:\n\n* schizophrenia spectrum disorders\n* other psychotic disorders\n* mental retardation\n* nicotine abuse/dependency only\n* prescription drug abuse/dependency only\n* planning to move out of the catchment area during the study\n* not able to read or write Norwegian'}, 'identificationModule': {'nctId': 'NCT00447733', 'acronym': 'ROP', 'briefTitle': 'Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders', 'orgStudyIdInfo': {'id': '78i068'}, 'secondaryIdInfos': [{'id': 'NFR175394/V50', 'type': 'OTHER_GRANT', 'domain': 'The Norwegian Research Council/NFR175394/V50'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated treatment', '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.', 'interventionNames': ['Behavioral: Integrated mental health and substance use treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders.', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Integrated mental health and substance use treatment', 'type': 'BEHAVIORAL', 'otherNames': ['dual disorder treatment', 'co-occurring disorders'], 'description': 'Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.', 'armGroupLabels': ['Integrated treatment']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'otherNames': ['TAU', 'non-manualized'], 'description': 'Non-standardized psychiatric outpatient treatment', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rolf W. Gråwe, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'SINTEF Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.d.; Assistent Professor; University of Oslo', 'investigatorFullName': 'Rolf W. Grawe', 'investigatorAffiliation': 'University of Oslo'}}}}