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Alcohol DependencePhase 2NCT00423904

Brief Alcohol Intervention in General Hospitals

A Phase 2 study testing Brief intervention in people with Alcohol Dependence and Alcohol Abuse, run by University Medicine Greifswald.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to reveal the most promising procedure for implementing alcohol screening and intervention in general hospitals and to find out, if and to which extent non-specialist health professionals can be qualified to carry out motivational intervention on their own or if there is a need for a… Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Brief intervention
How many people
1,035 participants
Where
No sites listed yet
Study dates
Oct 2001to Aug 2005
Phase
Phase 2
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 to 64 years
  • All sexes
  • Adult

Who may be able to join

  • Alcohol dependence
  • Alcohol abuse
  • At-risk drinking
  • Heavy episodic drinking

Who cannot join

  • Persons physically and mentally not capable of participating in study
  • Persons with a hospital stay of less than 24 hours

About this study

Official title: Implementing Early Intervention for Alcohol Use Disorders in the General Hospital

The purpose of the study is to reveal the most promising procedure for implementing alcohol screening and intervention in general hospitals and to find out, if and to which extent non-specialist health professionals can be qualified to carry out motivational intervention on their own or if there is a need for a specialized counseling services. In a randomized controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to three conditions: (1) Intervention by a liaison service (LC): Counselling based on the Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI, and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be conducted after 12 months and includes abstinent point prevalence rates, drinks per day, help-seeking, stage progress and cost-effectiveness analysis.

Read the detailed description

Background: High prevalence rates (10 - 25 %) and a promising setting for proactive intervention strategies make the general hospital a first choice setting for secondary prevention of alcohol-related disorders. Efficient screening instruments have been developed for early detection. With regard to the severity of alcohol problem (e.g. alcohol dependence vs. heavy episodic drinking) and the motivation to change, the target group is very heterogeneous. Although there are counseling strategies that take into account this heterogeneity, there is still a lack of implementation and poor knowledge about different implementation strategies in routine care. Objectives: To evaluate the effectiveness of a proactive secondary preventive intervention based on the TTM and on MI in a representative sample of general hospital patients carried out by a liaison service versus non-specialist physicians trained in counseling techniques by staff of the study. Methods: A sample of 1,479 alcohol at-risk-drinking, alcohol abusing or alcohol dependent patients from four general hospitals detected by screening questionnaires will be assigned to (1) a group counseled by an addiction liaison service, (2) a group counseled by the physicians of the ward, and (3) to an assessment-only condition with treatment as usual. Outcome will be measured one year later and will include abstinence point prevalence rates, stage progress, help seeking, and cost-effectiveness analysis. Expected impact: The project will yield new scientific knowledge on how to implement early intervention for alcohol at-risk-drinking and alcohol use disorders in the general hospital. Results of the study shall be transferred to nationwide practice guideline proposals. The study will contribute to the improvement of the health care system as well as the education of medical students. The study is designed to reveal empirical evidence for proactive TTM-based interventions for individuals suffering from a prevalent substance use disorder.

Being tested
Brief intervention
Keywords
Early intervention, Brief intervention, alcohol, general hospital
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief interventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduced alcohol consumption

  2. Increased alcohol-specific help-seeking

Secondary outcomes (2)

  1. Increased readiness to change drinking behaviour

  2. Increased well-being

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startOct 2001
  3. Study completionAug 2005

Resources

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 2
Primary purpose
Early clinical test
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
1,035 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423904
Sponsor's protocol ID
E1_P1
Other IDs
01EB0120, 01EB0420
Status last verified
Jan 2007
First submitted
17 Jan 2007
Last updated
18 Jan 2007
Results posted
No

Publications

  • Freyer J, Bott K, Riedel J, Wedler B, Meyer C, Rumpf HJ, John U, Hapke U. Psychometric properties of the 'Processes of Change' scale for alcohol misuse and its short form (POC-20). Addict Behav. 2006 May;31(5):821-32. doi: 10.1016/j.addbeh.2005.06.007. Epub 2005 Jul 1.

    PubMed 15993545

  • Freyer J, Coder B, Bischof G, Baumeister SE, Rumpf HJ, John U, Hapke U. Intention to utilize formal help in a sample with alcohol problems: a prospective study. Drug Alcohol Depend. 2007 Mar 16;87(2-3):210-6. doi: 10.1016/j.drugalcdep.2006.08.018. Epub 2006 Sep 18.

    PubMed 16979304

  • Freyer J, Coder B, Pockrandt C, Hartmann B, Rumpf HJ, John U, Hapke U. [General hospital patients with alcohol problems welcome counselling]. Gesundheitswesen. 2006 Jul;68(7):429-35. doi: 10.1055/s-2006-926908. German.

    PubMed 16868869

  • Freyer J, Tonigan JS, Keller S, John U, Rumpf HJ, Hapke U. Readiness to change versus readiness to seek help for alcohol problems: the development of the Treatment Readiness Tool (TReaT). J Stud Alcohol. 2004 Nov;65(6):801-9. doi: 10.15288/jsa.2004.65.801.

    PubMed 15700519

  • Freyer J, Tonigan JS, Keller S, Rumpf HJ, John U, Hapke U. Readiness for change and readiness for help-seeking: a composite assessment of client motivation. Alcohol Alcohol. 2005 Nov-Dec;40(6):540-4. doi: 10.1093/alcalc/agh195. Epub 2005 Sep 26.

    PubMed 16186144

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brief intervention in people with Alcohol Dependence and Alcohol Abuse, run by University Medicine Greifswald.

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 4 inclusion and 2 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 18 Jan 2007. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Reduced alcohol consumption. The study lists 2 primary outcomes in all. 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 NCT00423904, which also lists 5 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 18 Jan 2007.

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