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Problematic Alcohol UseeChangeNATNCT02283593

Self-help Internet-based Relapse Prevention for Problematic Alcohol Use

An observational study of Problematic Alcohol Use, 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

The purpose of this study is to observe and evaluate the use of a relapse prevention program over time among internet help-seekers. Participants are recruited via a nationally known portal for assisting anonymous individuals with changing their problematic alcohol use in a healthier direction (alkoholhjalpen.se). Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Problematic Alcohol Use
What is being tested?
eChange.se
How many people
4,165 participants
Where
1 siteSweden
Study dates
Mar 2013to May 2015
Phase
Observational
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Internet help-seekers with problematic alcohol use.

Who may be able to join

  • AUDIT >5 points for women
  • AUDIT >7 points for men

Who cannot join

  • AUDIT <6 points for women
  • AUDIT <8 points for men

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet, Department of Clinical Neuroscience

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: Self-help Internet-based Relapse Prevention for Problematic Alcohol Use: A Naturalistic Study Among Internet Help-seekers

The purpose of this study is to observe and evaluate the use of a relapse prevention program over time among internet help-seekers. Participants are recruited via a nationally known portal for assisting anonymous individuals with changing their problematic alcohol use in a healthier direction (alkoholhjalpen.se). The intervention offered lasts 10 weeks and includes 7 relapse prevention modules, with a three-week pause between the 6th and 7th modules. Baseline data are collected regarding substance use and psychosocial health and follow-up takes place 10 weeks after recruitment. The study is observational.

Being tested
eChange.se

What participants receive

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

  • eChange.seBehavioural

    Also called SO (Self-help online, see Blankers et al., 2011)

    7 modules: 1. Making a decisional balance 2. Setting a goal for alcohol consumption 3. Learning self control skills 4. Identifying risk situations 5. Dealing with urges 6. Dealing with emotions and with social pressure 7. Developing a crisis plan

What is being measured

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

  1. Timeline Follow Back (TLFB)

    Quantity/frequency measure of alcohol consumption

    Measured: 10 weeks

  2. The Alcohol Use Disorders Identification Test (AUDIT)

    3 consumption questions and 7 problem-related questions regarding alcohol consumption

    Measured: 10 weeks

Secondary outcomes (6)

  1. The Drug Use Disorders Identification Test (DUDIT)

    3 consumption questions and 7 problem-related questions regarding drug consumption

    Measured: 10 weeks

  2. The Hospital Anxiety and Depression Scale (HADS)

    14 questions, 7 on anxiety symptoms and 7 on depression symptoms

    Measured: 10 weeks

  3. The Readiness to Change Questionnaire (RTCQ)

    12 questions rated from -2 to +2 and divided into 3 dimensions: precontemplation, contemplation and action

    Measured: 10 weeks

  4. The Readiness Ruler

    Scores between 0 and 100. In this study, "I am not ready to change my drinking habits" and "I am very much ready to change my drinking habits".

    Measured: 10 weeks

  5. The World Health Quality of Life - shorter version (WHOQOL - BREF)

    26 questions measuring four domains of quality of life: physical, psychological, social and environment.

    Measured: 10 weeks

  6. EQ-5D-5L

    5 questions on the following dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/discomfort

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
4,165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283593
Sponsor's protocol ID
2013/686-31/5
Other IDs
KI 2-1341/2014
Acronym
eChangeNAT
Status last verified
Aug 2015
First submitted
2 Nov 2014
Last updated
1 Sep 2015
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

Questions about this trial

What is this clinical trial studying?

An observational study of Problematic Alcohol Use, 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 2 inclusion and 2 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 1 Sep 2015. 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?

Timeline Follow Back (TLFB) (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 NCT02283593, 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 1 Sep 2015.

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