Anxiety DisordersROPNCT00447733
Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
A study testing Integrated mental health and substance use treatment and Treatment as usual in people with Anxiety Disorders and Mood Disorders, run by University of Oslo.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Mood Disorders, Substance Use Disorders
- What is being tested?
- Integrated mental health and substance use treatment and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders, Mood Disorders, Substance Use Disorders
- Being tested
- Integrated mental health and substance use treatment, Treatment as usual
- Keywords
- mental health, substance use, treatment
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated mental health and substance use treatmentBehavioural
Also called dual disorder treatment, co-occurring disorders
Psychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way.
Treatment as usualBehavioural
Also called TAU, non-manualized
Non-standardized psychiatric outpatient treatment
| Study group | Role | What they receive |
|---|---|---|
| Integrated treatment | Experimental | 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. Receives: Behavioral: Integrated mental health and substance use treatment |
| Treatment as usual | Active comparator | Non-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change during 6 and 12 months follow-up
Secondary outcomes (1)
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.
Measured: Change during 6 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research
- Responsible party
- Principal investigator, Rolf W. Grawe, University of Oslo
- Investigators
- Rolf W. Gråwe, Ph.D, Principal investigator, Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447733
- Sponsor's protocol ID
- 78i068
- Other IDs
- NFR175394/V50
- Acronym
- ROP
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2007
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24597469Wusthoff 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.
PubMed 22933843
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
- ClinicalTrials.gov ID
- NCT00447733
- Acronym / sponsor ID
- ROP / 78i068
- Conditions
- Anxiety Disorders, Mood Disorders, Substance Use Disorders
- Keywords
- mental health, substance use, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- SINTEF Health Research
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated treatment | Experimental | Behavioral: Integrated mental health and substance use treatmentEvidence-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. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualNon-manualized clinic-based treatment provided by therapists without formal training in integrated treatment of co-occurring disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- schizophrenia spectrum disorders
- other psychotic disorders
- mental retardation
- nicotine abuse/dependency only
- prescription drug abuse/dependency only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated mental health and substance use treatmentAlso: dual disorder treatment, co-occurring disordersPsychosocial and drug treatment targeting both the substance use disorder and the psychiatric disorder in an integrated and comprehensive way. | Behavioural | Integrated treatment |
| Treatment as usualAlso: TAU, non-manualizedNon-standardized psychiatric outpatient treatment | Behavioural | Treatment as usual |
Primary outcome
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.
1 secondary outcome
The Addiction Severity Index (Europ ASI)
Time frame: Change during 6 and 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 24597469Wusthoff 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.
- Derived from this study: PubMed 22933843Wusthoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf W. Gråwe, Ph.D principal investigator
Alcohol and Drug Treatment Health Trust in Central Norway; Norwegian Centre of Addiction Research, University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Integrated mental health and substance use treatment and Treatment as usual in people with Anxiety Disorders and Mood Disorders, run by University of Oslo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447733, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.