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Dual-Diagnosis and Compulsory Treatment

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ClinicalTrials.gov Identifier: NCT00970372
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF

Tracking Information
First Submitted Date September 1, 2009
First Posted Date September 2, 2009
Last Update Posted Date April 16, 2014
Study Start Date September 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2009)
Substance use outcomes measured by Europ-ASI Quality of Life [ Time Frame: 6 months after discharge ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00970372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 1, 2009)
Psychological distress (SCL-90-R) [ Time Frame: 6 months after discharge ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dual-Diagnosis and Compulsory Treatment
Official Title Compulsory Treatment of Alcohol and Drug Dependent Patients and Dual Diagnosis in 5 Counties of Health Region South-East, Norway
Brief Summary

The Norwegian Social and Welfare Act of 1992, opened for compulsory commitment of patients with serious alcohol and drug problems to inpatient care. Clinical research of compulsory committed dual diagnosed patients is to date unavailable and is demanded by the health authorities of Norway. Because there has been limited examination/screening and no post-treatment research efforts on this group of patients, the investigators have limited knowledge of the treatment as well as the patient group. Do compulsory treated patients differ from those voluntarily admitted? Does this type of treatment influence the patients' motivation to change their behaviour, and does the treatment effort lead to positive outcome effects in the long run?

The primary aim is to acquire new and in depth descriptive knowledge about the compulsory treated group of patients according to: Drug dependence, psychiatric and somatic co-morbidity and socio-demographic characteristics, and investigate whether the treatment yields the intended outcomes in terms of improved substance abuse measures.

A second aim is to compare the group with a corresponding group of voluntarily admitted patients within the same wards. A follow-up interview focusing on motivational issues within 6 months post treatment to evaluate the long-term results of the treatment is planned.

A quasi-experimental, prospective case-control study will be conducted. Compulsory committed patients in five counties during a two year period, will be compared to a group of voluntarily admitted patients. The groups will be compared regarding 1) description and screening 2) motivation to change and 3) outcome results after 6 months.

Both official authorities as well as clinical practitioners would benefit from valid Norwegian results and knowledge within this field to form further policies and evidence based best practice for this vulnerable group of patients.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population In five counties there are a total of eight beds reserved for compulsory treatment according to the LOST § 6.2 regulation. Of these, four are situated at the Addiction Unit at Sørlandet Hospital (Kristiansand) and four at the Vestfold Clinic, part of the psychiatric section in the county of Vestfold, Tønsberg. It will be necessary to include both sites for two years of inclusion in this study to obtain sufficient samples, as there are only approximately 35 patients in the compulsory committed category annually in this region. All eligible patients compulsory committed to the two wards in Kristiansand and Tønsberg during a twenty-four month period will be asked to participate during their initial assessment.
Condition
  • Substance-Related Disorders
  • Dual Diagnosis
Intervention Not Provided
Study Groups/Cohorts
  • Involuntary patients
    Compulsory treated patients according to the Norwegian Social and Welfare Act of 1992. Most patients have dualdiagnosis.
  • Voluntary patients
    Voluntary patients on the same wards. Most patients have dual-diagnosis.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 15, 2014)
202
Original Estimated Enrollment
 (submitted: September 1, 2009)
220
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with alcohol and substance use disorders
  • Estimated premorbid IQ of 70 or higher

Exclusion Criteria:

  • Active drug or alcohol abuse
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00970372
Other Study ID Numbers SSHF_815360
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sorlandet Hospital HF
Study Sponsor Sorlandet Hospital HF
Collaborators Not Provided
Investigators
Study Director: Øistein Kristensen Sørlandet Sykehus HF
PRS Account Sorlandet Hospital HF
Verification Date April 2014