Internet treatment of alcohol dependence in primary care
| ISRCTN | ISRCTN69957414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69957414 |
| Protocol serial number | N/A |
| Sponsor | Addiction Centre Stockholm (Beroendecentrum Stockholm) |
| Funders | Forskningsrådet om Hälsa, Arbetsliv och Välfärd, Swedish Research Council Funding for Clinical Research in Medicine |
- 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
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
Contact information
Scientific
Riddargatan 1
Mottagningen för alkohol och hälsa
Stockholm
11435
Sweden
| Phone | +46 (0)8 12345780 |
|---|---|
| sven.andreasson@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial between-groups design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Change of weekly alcohol consumption and number of heavy drinking days measured by the Time line follow back instrument. |
| Key secondary outcome measure(s) |
1. Change of degree of alcohol dependence ICD 10 criteria is measured using questionnaires at baseline, 3 and 12months |
| Completion date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
11435 Stockholm
11435
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | 23/02/2023 | 11/07/2023 | Yes | No | |
| Protocol article | protocol | 30/12/2019 | 16/12/2020 | Yes | No |
| Other publications | Moderation analysis | 14/02/2025 | 17/02/2025 | Yes | No |
| Other unpublished results | 10/05/2022 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 34436 Abstract results.pdf
- Other unpublished results
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.
