Condition category
Mental and Behavioural Disorders
Date applied
15/08/2006
Date assigned
04/12/2006
Last edited
09/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colin Drummond

ORCID ID

Contact details

Section of Addictive Behaviour
St Georges University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
sgju970@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

STEPWICE

Study hypothesis

1. Screening and stepped care interventions for alcohol use disorder are as effective as minimal interventions in primary care.
2. Screening and stepped care interventions for alcohol use disorder are as cost-effective as minimal interventions in primary care.

Ethics approval

Iechyd Morgannwg Health Local Research Ethics Committee approval gained on 5th July 2000.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Alcohol Use Disorders

Intervention

Stepped Care Intervention (SCI):
This consists of three care steps:
a. All SCI subjects receive one 40-minute session of Brief Motivational Intervention (BMI) in the general practice setting conducted by a trained Practice Nurse (PN). This intervention will be manual-guided using the method of Rollnick et al. All SCI subjects will then be followed-up by the PN with a phone call at two weeks, and face-to-face interview at one month post intervention in the primary care setting to assess response to the intervention. Subjects ‘not improved’ will be referred to Step b.
b. Manual-guided, outpatient Motivational Enhancement Therapy (MET) (four one hour sessions over two weeks) adapted from the Medical Research Council (MRC) funded UK Alcohol Treatment Trial intervention protocol (similar to the MET intervention used in Project MATCH), conducted by a trained Addiction Prevention Practitioner (APP) attached to the collaborating practices. The APP model has been described by Ghodse et al. This will be followed by a further phone call at two weeks and a follow-up face-to-face interview at one month post-MET by the PN to assess response to intervention.
c. Subjects ‘not improved’ will be referred to a specialist Community Alcohol Team (CAT) to receive specialist treatment (including, as necessary, inpatient care, outpatient counselling, group therapy, relapse prevention treatment, medication) with no limit on duration or intensity of Intervention.

Control intervention:
Minimal intervention will consist of one five minute session of advice to cut down drinking conducted by the trained PN and provision of an information leaflet on services available locally for problem drinkers, and a self-help booklet. The minimal intervention will also be manual guided.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Alcohol consumption obtained using the Time Line Follow-Back interview method (TLFB). This method will be used to provide two measures identical to the primary outcome measures used in project MATCH (Project MATCH Research Group, 1997), namely:
1. Mean number of Drinks per Drinking Day (DDD)
2. Percentage of Days Abstinent (PDA)

Secondary outcome measures

1. Alcohol-related problems: Alcohol Problems Questionnaire (APQ)
2. Blood investigations (Gamma-GlutamylTransferase [GGT], Carbohydrate-Deficient Transferrin [CDT-Axis], Mean Corpuscular Volume [MCV])
3. Health related Quality of Life (Euroqol questionnaire [EQ-5D], Short Form health surveys [SF-36, SF-12])
4. Health economic measures
5. Patient compliance (using attendance records)
6. Patient and clinician satisfaction using scales developed by the Kings College Group.

Alcohol consumption and secondary measures 1, 2, & 3 will be included in the baseline assessment to:
a. test the adequacy of matching between groups, and
b. to act as covariates in subsequent analyses to control for baseline values.

The Severity of Alcohol Dependence Questionnaire (SADQ), the Situational Confidence Questionnaire (SCQ) and the short Readiness to Change Questionnaire will also be administered at baseline and later investigated as predictors of outcome and care step utilisation.

Overall trial start date

01/06/2000

Overall trial end date

31/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. Age 18 to 65 (the reason for limiting the age range is that patients above and below this range are catered for by different services in Step 3)
3. Alcohol Use Disorders Identification Test (AUDIT) score more than or equal to eight
4. Diagnosis of an Alcohol Use Disorder according to the Internation Classification of Diseases (ICD-10) (hazardous or harmful drinking, alcohol dependence) as assessed by the baseline research interview
5. Consent to participate in either treatment, and follow-up
6. Willing to nominate an independent informant who the research team can contact to obtain information at baseline and during follow-up, and to nominate a ‘locator’ who will be able to assist in tracing the subject at follow-up (the independent informant and locator may be the same person)
7. Stable place of residence
8. Living within commuting distance of the practice
9. No treatment for substance misuse in previous 30 days

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

236

Participant exclusion criteria

1. Current severe mental illness
2. Primary drug dependence (except nicotine and cannabis)
3. Severe physical illness that would preclude participation
4. Current legal problems likely to interfere with follow-up
5. Severe brain damage or mental impairment

Recruitment start date

01/06/2000

Recruitment end date

31/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Addictive Behaviour
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

Wales Office of Research and Development (UK)

Sponsor details

National Assembly for Wales
Cardiff Bay
Cardiff
CF99 1NA
United Kingdom
+44 (0)29 2082 5111
WORD.Wales@gsi.gov.uk

Sponsor type

Government

Website

http://www.word.wales.gov.uk/

Funders

Funder type

Government

Funder name

Wales Office of Research and Development (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19880936

Publication citations

  1. Results

    Drummond C, Coulton S, James D, Godfrey C, Parrott S, Baxter J, Ford D, Lervy B, Rollnick S, Russell I, Peters T, Effectiveness and cost-effectiveness of a stepped care intervention for alcohol use disorders in primary care: pilot study., Br J Psychiatry, 2009, 195, 5, 448-456, doi: 10.1192/bjp.bp.108.056697.

Additional files

Editorial Notes