Alcohol Use DisordersNCT02671019
Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
A study testing Guide to better alcohol habits in people with Alcohol Use Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- Guide to better alcohol habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteSweden
- Study dates
- 12 Nov 2015to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- Resident in Stockholm County
Who cannot join
- Lack of understanding of the Swedish language.
- Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- Doctor's assessment that there is a need for medication for alcohol dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
- The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
- The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
Read more
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
- Conditions
- Alcohol Use Disorders
- Being tested
- Guide to better alcohol habits
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guide to better alcohol habitsBehavioural
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based treatment | Experimental | A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention. Receives: Behavioral: Guide to better alcohol habits |
| Face-to-face treatment | Active comparator | Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment. Receives: Behavioral: Guide to better alcohol habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Measured: 3 months post-randomization
Secondary outcomes (35)
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Measured: 6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Measured: 12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Measured: 24 months post-randomization
Alcohol Use Disorders Identification Test score
Measured: 3 months post-randomization
Alcohol Use Disorders Identification Test score
Measured: 6 months post-randomization
Alcohol Use Disorders Identification Test score
Measured: 12 months post-randomization
Alcohol Use Disorders Identification Test score
Measured: 24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Measured: 3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Measured: 6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Measured: 12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Measured: 24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Measured: 3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Measured: 6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Measured: 12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Measured: 24 months post-randomization
Number of days absent from work due to illness
Measured: 3 months post-randomization
Number of days absent from work due to illness
Measured: 6 months post-randomization
Number of days absent from work due to illness
Measured: 12 months post-randomization
Number of days absent from work due to illness
Measured: 24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Measured: 3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Measured: 6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Measured: 12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Measured: 24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Measured: 3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Measured: 6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Measured: 12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Measured: 24 months post-randomization
Score on EQ-5D measuring the quality of life
Measured: 3 months post-randomization
Score on EQ-5D measuring the quality of life
Measured: 6 months post-randomization
Score on EQ-5D measuring the quality of life
Measured: 12 months post-randomization
Score on EQ-5D measuring the quality of life
Measured: 24 months post-randomization
Cost for treatment
Measured: 3 months post-randomization
Cost for treatment
Measured: 6 months post-randomization
Cost for treatment
Measured: 12 months post-randomization
Cost for treatment
Measured: 24 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start12 Nov 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Kristina Sinadinovic, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671019
- Sponsor's protocol ID
- 2014/1758-31/2
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2016
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02671019
- Acronym / sponsor ID
- 2014/1758-31/2
- Conditions
- Alcohol Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
- The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
- The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based treatment | Experimental | Behavioral: Guide to better alcohol habitsA five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention. |
| Face-to-face treatment | Active comparator | Behavioral: Guide to better alcohol habitsSame treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- Resident in Stockholm County
Key exclusion criteria (3 listed)
- Lack of understanding of the Swedish language.
- Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- Doctor's assessment that there is a need for medication for alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guide to better alcohol habitsA treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention. | Behavioural | Face-to-face treatment, Internet-based treatment |
Primary outcome
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 3 months post-randomization
35 secondary outcomes
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time frame: 24 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 3 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 6 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 12 months post-randomization
Alcohol Use Disorders Identification Test score
Time frame: 24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time frame: 24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time frame: 24 months post-randomization
Number of days absent from work due to illness
Time frame: 3 months post-randomization
Number of days absent from work due to illness
Time frame: 6 months post-randomization
Number of days absent from work due to illness
Time frame: 12 months post-randomization
Number of days absent from work due to illness
Time frame: 24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Time frame: 24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Time frame: 24 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 3 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 6 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 12 months post-randomization
Score on EQ-5D measuring the quality of life
Time frame: 24 months post-randomization
Cost for treatment
Time frame: 3 months post-randomization
Cost for treatment
Time frame: 6 months post-randomization
Cost for treatment
Time frame: 12 months post-randomization
Cost for treatment
Time frame: 24 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guide to better alcohol habits in people with Alcohol Use Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method (time frame: 3 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.