Condition category
Mental and Behavioural Disorders
Date applied
17/11/2017
Date assigned
07/06/2018
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Alcohol dependence is a common disorder and has a continuum regarding severity. Most alcohol dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment seeking in this group is low however, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is relevant to discuss in many primary care (PC) consultations and PC is less stigmatizing than addiction care units. But general practitioners (GPs) are reluctant to engage in treating alcohol problems due to time constraints and lack of knowledge about how to ask about and how to treat alcohol problems. Screening and brief interventions are effective for high consumers but there are few studies on dependence. Internet based interventions are attractive to and are shown to reach people with alcohol problems. Yet there are no internet studies on alcohol dependence in PC. The aim with this study is to broaden the base for treatment of alcohol dependence by lowering the threshold for treatment seeking and to reach a larger part of the target group with evidence based treatment. In the present project, the aim is to study the effectiveness of an Internet based Cognitive Behavioral Therapy (iCBT) when added to treatment as usual (TAU) for alcohol dependence in PC, and compare treatment outcome with TAU only.

Who can participate?
Adults aged 18 and older who have a dependence on alcohol.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive TAU from their GPs. Those in the second group receive TAU as well as the iCBT therapy for two months. All participants are then answering questionnaires, take blood samples again at 3 and 12 months which they are given computerized feedback on.

What are the possible benefits and risks of participating?
Participants may benefit from receive extra treatment. All participants will be given what GPs provide patients according to the routines in primary care so there is no added risk.

Where is the study run from?
Karolinska Institutet Stockholm (Sweden)

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
1. Swedish Research Council for Health, Working Life and Welfare (Sweden)
2. Swedish Research Council Funding for Clinical Research in Medicine (Sweden)

Who is the main contact?
Professor Sven Andréasson
sven.andreasson@ki.se

Trial website

www.alkoholohalsa.se

Contact information

Type

Scientific

Primary contact

Prof Sven Andréasson

ORCID ID

Contact details

Riddargatan 1
Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden
+46 (0)8 12345780
sven.andreasson@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Internet-based Treatment of Alcohol Dependence in primary care - a randomised controlled trial

Acronym

iTAP

Study hypothesis

Internet based treatment (iCBT), when added to treatment as usual (TAU) for patients with alcohol dependence in PC, improves treatment outcome.

Ethics approval

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

Study design

Randomized controlled trial between-groups design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol dependence

Intervention

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.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

01/01/2016

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant 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

Recruitment start date

24/08/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet Stockholm
Riddargatan 1 11435 Stockholm
11435

Sponsor information

Organisation

Addiction Centre Stockholm (Beroendecentrum Stockholm)

Sponsor details

Finsens väg 8
Stockholm
11219
Sweden
+46 (0)8 12345780
sven.andreasson@sll.se

Sponsor type

Hospital/treatment centre

Website

www.beroendecentrumstockholm.se

Funders

Funder type

Research council

Funder name

Forskningsrådet om Hälsa, Arbetsliv och Välfärd

Alternative name(s)

Swedish Research Council for Health, Working Life and Welfare, FORTE

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Swedish Research Council Funding for Clinical Research in Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Sven Andreasson, sven.andreasson@ki.se

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes