Internet treatment of alcohol dependence in primary care

ISRCTN	ISRCTN69957414
DOI	https://doi.org/10.1186/ISRCTN69957414
Secondary identifying numbers	N/A

Submission date: 17/11/2017
Registration date: 07/06/2018
Last edited: 17/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 March 2021

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

Study website

Contact information

Prof Sven Andréasson
Scientific

Riddargatan 1
Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden

Phone	+46 (0)8 12345780
Email	sven.andreasson@ki.se

Study information

Study design	Randomized controlled trial between-groups design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Internet-based Treatment of Alcohol Dependence in primary care - a randomised controlled trial
Study acronym	iTAP
Study objectives	Internet based treatment (iCBT), when added to treatment as usual (TAU) for patients with alcohol dependence in PC, improves treatment outcome.
Ethics approval(s)	Regional Ethics Review Board in Stockholm, 07/12/2016, 17/10/2017, ref: Dnr 2016/1367-31/2.
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2016
Completion date	31/03/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	260
Total final enrolment	264
Key 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
Key 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
Date of first enrolment	24/08/2017
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institutet Stockholm

Riddargatan 1
11435 Stockholm
11435
Sweden

Sponsor information

Addiction Centre Stockholm (Beroendecentrum Stockholm)
Hospital/treatment centre

Finsens väg 8
Stockholm
11219
Sweden

Phone	+46 (0)8 12345780
Email	sven.andreasson@sll.se
Website	www.beroendecentrumstockholm.se
"ROR"	https://ror.org/04g380834

Funders

Funder type

Research council

Forskningsrådet om Hälsa, Arbetsliv och Välfärd
Government organisation / Local government

Alternative name(s): Swedish Research Council for Health, Working Life and Welfare, FORTE
Location: Sweden

Swedish Research Council Funding for Clinical Research in Medicine

No information available

Results and Publications

Intention to publish date	30/06/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Sven Andreasson, sven.andreasson@ki.se

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/12/2019	16/12/2020	Yes	No
Other unpublished results			10/05/2022	No	No
Results article		23/02/2023	11/07/2023	Yes	No
Other publications	Moderation analysis	14/02/2025	17/02/2025	Yes	No

Additional files

34436 Abstract results.pdf

Editorial Notes

17/02/2025: Publication reference added.
11/07/2023: Publication reference added.
10/05/2022: Unpublished results have been uploaded as an additional file.
16/12/2020: The following changes have been made:
1. The overall trial end date has been updated from 31/12/2020 to 31/03/2021.
2. The intention to publish date has been updated from 31/12/2021 to 30/06/2022.
3. Publication reference and total final enrolment added.
10/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 31/12/2019.
2. The overall trial end date has been updated from 31/12/2019 to 31/12/2020.
3. The intention to publish date has been updated from 31/12/2020 to 31/12/2021.