Alcohol AbuseIMSNCT02888002
Internet-based vs Face-to-face Treatment for Alcohol Dependence
A study testing Guide to better alcohol habits in people with Alcohol Abuse and Alcohol Dependence, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use
- 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
- 310 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2015to 30 Mar 2020
- 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
- AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)
Who cannot join
- Risk of severe withdrawal symptoms.
- Risk of suicide.
- Other psychiatric diagnosis that requires current treatment.
- Need for medication for alcohol dependence.
- Inadequate Swedish language skills.
- No Internet access
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Public Health Sciences
Stockholm, 17176
About this study
Official title: Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.
Read the detailed description
A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.
- 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
Also called Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), Behavioral Self-Control Training, eChange
A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based treatment | Experimental | "Guide to better alcohol habits online". An Internet-based treatment program with online counselor support. Receives: Behavioral: Guide to better alcohol habits |
| Face-to-face treatment | Experimental | "Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic. Receives: Behavioral: Guide to better alcohol habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back (TLFB)
Change in number of standard drinks per day during last 7 days
Measured: 3, 6, 12 and 24 months
Secondary outcomes (8)
Time Line Follow Back (TLFB) Change in number of consumption days
Change in number of drinking days during last 7 days
Measured: 3, 6, 12 and 24 months
Time Line Follow Back (TLFB) Change in number of days binge-drinking days
Change in number of binge-drinking days during last 7 days
Measured: 3, 6, 12 and 24 months
Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Change in Quantity, Frequency and Binge-drinking scores during the time since last reported
Measured: 3, 6, 12 and 24 months
Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use since last reported
Measured: 3, 6, 12 and 24 months
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Change in total MADRS-S score, as a summarized measure of depression
Measured: 3, 6, 12 and 24 months
Generalised Anxiety Disorder Assessment (GAD-7)
Change in total GAD-7 score, as a summarized measure of anxiety
Measured: 3, 6, 12 and 24 months
Questions about help-seeking behavior from family and friends
Change in help-seeking for alcohol related problems from family and friends. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387
Measured: 3, 6, 12 and 24 months
Questions about help-seeking behavior from professionals
Change in help-seeking for alcohol related problems from professionals. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start1 Dec 2015
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Sven Andreasson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888002
- Sponsor's protocol ID
- 2014/1758-31/2-2
- Acronym
- IMS
- Status last verified
- Sep 2020
- First submitted
- 17 Jan 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.
PubMed 25300885
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02888002
- Acronym / sponsor ID
- IMS / 2014/1758-31/2-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Sep 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.
A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.
Detailed description
A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based treatment | Experimental | Behavioral: Guide to better alcohol habits"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support. |
| Face-to-face treatment | Experimental | Behavioral: Guide to better alcohol habits"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)
Key exclusion criteria (6 listed)
- Risk of severe withdrawal symptoms.
- Risk of suicide.
- Other psychiatric diagnosis that requires current treatment.
- Need for medication for alcohol dependence.
- Inadequate Swedish language skills.
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 habitsAlso: Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), Behavioral Self-Control Training, eChangeA 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist. | Behavioural | Face-to-face treatment, Internet-based treatment |
Primary outcome
Time Line Follow Back (TLFB)
Time frame: 3, 6, 12 and 24 months
Change in number of standard drinks per day during last 7 days
8 secondary outcomes
Time Line Follow Back (TLFB) Change in number of consumption days
Time frame: 3, 6, 12 and 24 months
Time Line Follow Back (TLFB) Change in number of days binge-drinking days
Time frame: 3, 6, 12 and 24 months
Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Time frame: 3, 6, 12 and 24 months
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 3, 6, 12 and 24 months
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Time frame: 3, 6, 12 and 24 months
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 3, 6, 12 and 24 months
Questions about help-seeking behavior from family and friends
Time frame: 3, 6, 12 and 24 months
Questions about help-seeking behavior from professionals
Time frame: 3, 6, 12 and 24 months
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 2 Sep 2020.
- Background: PubMed 25300885Sinadinovic K, Wennberg P, Johansson M, Berman AH. Targeting individuals with problematic alcohol use via Web-based cognitive-behavioral self-help modules, personalized screening feedback or assessment only: a randomized controlled trial. Eur Addict Res. 2014;20(6):305-18. doi: 10.1159/000362406. Epub 2014 Oct 4.
- Clinic websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sven Andreasson, MD, PhD principal investigator
Karolinska Institutet
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 Abuse and Alcohol Dependence, 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 1 inclusion and 6 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 2 Sep 2020. 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?
Time Line Follow Back (TLFB) (time frame: 3, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888002, which also lists 1 linked publication.
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 2 Sep 2020.