Internet treatment of alcohol dependence in primary care

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN69957414
• Date of registration: 07/06/2018
• Prospective Registration: No
• Primary sponsor: Addiction Centre Stockholm (Beroendecentrum Stockholm)
• Public title: Internet treatment of alcohol dependence in primary care
• Scientific title: Internet-based Treatment of Alcohol Dependence in primary care - a randomised controlled trial
• Date of first enrolment: 24/08/2017
• Target sample size: 260
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN69957414
• Study type: Interventional
• Study design: Randomized controlled trial between-groups design (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Sven Andréasson

Key inclusion & exclusion criteria

Inclusion criteria: 1. Alcohol dependence according to ICD-10 criteria, hazardous alcohol consumption
2. Male and female, >18 years of age
3. Housing in Stockholm county
Exclusion criteria: 1. Severe mental illness
2. Severe dependence in need of specialist treatment
3. Abuse or dependence of other substances apart from alcohol and/or nicotine
4. Severe somatic illness
5. Non-Swedish speaking

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol dependence
Mental and Behavioural Disorders
Alcohol dependence

Intervention(s)

The participants will first do an application and read information about the study. After this the participants will provide their concent and answer a number of questionnaires. If inclusion criteria are fulfilled and exclusion criteria are checked, the study coordinator will contact the participant and do the randomization. All participants then provide a blood sample and are scheduled for an appointment to the GP. Participants are randomly allocated to one of two groups.

The Treatment as usual (TAU) receive care from the general practitioners provide treatmnt according to local routines and the training given on feedback on assessment questionairs and biomarkers in blood, offer mediciaton for treatment if applicable.

The iCBT groups receive of adaptation of motivational enhancement therapy and CBT, for two months added to TAU (treatment as usual). In the intervention arm iCBT is added to TAU and will run for two months. Participants are reminded to start work with a new task every week in iCBT.

The treatment duration depends on what the GP finds applicable and will probably differ in duration and in content. TAU is given in both study arms. Follow up in both study arms (as described before) are 3 and 12 months from baseline and involves providing blood samples and answering questionnaires.

Primary Outcome(s)

Change of weekly alcohol consumption and number of heavy drinking days measured by the Time line follow back instrument.

Secondary Outcome(s)

1. Change of degree of alcohol dependence ICD 10 criteria is measured using questionnaires at baseline, 3 and 12months
2. Change of consequences of drinking AUDIT scores is measured using questionnaires at baseline, 3 and 12 months
3. Change of symptoms of anxiety and depression HAD scores is measured using questionnaires at baseline, 3 and 12 months
4. Change of quality of life EQ5D is measured using questionnaires at baseline, 3 and 12 months
5. Change of levels of phosphatidylethanol (PEth) are measured using bloodsample at baseline, 3 and 12 months
6. Change of levels of aspartate aminotransferase (ASAT) are measured using bloodsample at baseline, 3 and 12 months
7. Change of levels of alanine aminotransferase (ALAT) are measured using bloodsample at baseline, 3 and 12 months
8. Change of levels of gamma-glutamyltransferase (GGT) are measured using bloodsample at baseline, 3 and 12 months
9. Patients’ satisfaction with treatment CSQ is measured using questionnaire at 3 months

Secondary ID(s)

N/A

Source(s) of Monetary Support

Forskningsrådet om Hälsa, Arbetsliv och Välfärd, Swedish Research Council Funding for Clinical Research in Medicine

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regional Ethics Review Board in Stockholm, 07/12/2016, 17/10/2017, ref: Dnr 2016/1367-31/2.

Results

• Results available: Yes
• Date Completed: 31/03/2021