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Alcohol AbuseNCT02377726

Anonymous Treatment on the Internet for Alcohol Dependence: A Randomised, Controlled Trial

A study testing Alkoholhjälpen counselor support, eChange Alkoholhjälpen and Alkoholhjälpen in people with Alcohol Abuse and Alcohol Dependence, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alkoholhjälpen counselor support, eChange Alkoholhjälpen and Alkoholhjälpen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,170 participants
Where
1 siteSweden
Study dates
1 Apr 2015to 30 Nov 2019
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 at least 3 criteria of alcohol dependence (ICD-10)

Who cannot join

  • 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

Other trials in Sweden

About this study

Official title: Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial

Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.

Read the detailed description

A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled 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. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.

Being tested
Alkoholhjälpen counselor support, eChange Alkoholhjälpen, Alkoholhjälpen
Keywords
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alkoholhjälpen counselor supportBehavioural

    Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.

  • eChange AlkoholhjälpenBehavioural

    An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help

  • AlkoholhjälpenBehavioural

    Also called alcoholhjalpen.se, alcohol-help-site

    A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum

Study groups in NCT02377726
Study groupRoleWhat they receive
Internet self-help with supportExperimentaleChange Alkoholhjälpen is an internet based self help program consisting of 5 modules. Patients will have access to Alkoholhjälpen counselor support through secure comments at every module they complete.
Receives: Behavioral: Alkoholhjälpen counselor support; Behavioral: eChange Alkoholhjälpen
Internet self-helpExperimentaleChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.
Receives: Behavioral: eChange Alkoholhjälpen
InformationActive comparatorBrief information on resources that can be accessed through the open access website Alkoholhjälpen: Information on alcohol and health, where and how to find treatment and an internet discussion forum.
Receives: Behavioral: Alkoholhjälpen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days)

    Change in total in consumption of alcohol last 7 days

    Measured: 3, 6, 12 and 24 months

Secondary outcomes (11)

  1. Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days)

    Change in number of standard drinks per day during last 7 days

    Measured: 3, 6, 12 and 24 months

  2. Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days)

    Change in number of consumption days during last 7 days

    Measured: 3, 6, 12 and 24 months

  3. Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days)

    Change in number of days binge-drinking days during last 7 days

    Measured: 3, 6, 12 and 24 months

  4. Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met)

    Change in number of criteria for alcohol dependence met

    Measured: 3, 6, 12 and 24 months

  5. Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met)

    Change in number of criteria for alcohol use disorder met

    Measured: 3, 6, 12 and 24 months

  6. Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use)

    Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

    Measured: 3, 6, 12 and 24 months

  7. Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score)

    Change in total MADRS-S score, as a summarized measure of depression

    Measured: 3, 6, 12 and 24 months

  8. 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

  9. The EuroQol generic health index (EQ5D)

    Change in total EQ5D score, as a summarized measure of quality of life

    Measured: 3, 6, 12 and 24 months

  10. Questions about help-seeking behavior

    Change in help-seeking for alcohol related problems from professionals

    Measured: 3, 6, 12 and 24 months

  11. Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends)

    Change in help-seeking for alcohol related problems from family and friends

    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.

  1. First posted4 Mar 2015 (estimated)
  2. Study start1 Apr 2015
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377726
Sponsor's protocol ID
2014/1758-31-2
Status last verified
Nov 2023
First submitted
26 Feb 2015
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No

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

  • Johansson M, Berman AH, Sinadinovic K, Lindner P, Hermansson U, Andreasson S. Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial. J Med Internet Res. 2021 Nov 24;23(11):e29666. doi: 10.2196/29666.

    PubMed 34821563

Questions about this trial

What is this clinical trial studying?

A study testing Alkoholhjälpen counselor support, eChange Alkoholhjälpen and Alkoholhjälpen 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 1 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 13 Nov 2023. 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) (Change in total in consumption of alcohol last 7 days) (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 NCT02377726, which also lists 2 linked publications.

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 13 Nov 2023.

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