Self-help Internet-based Relapse Prevention for Problematic Alcohol Use (eChangeNAT)

August 31, 2015 updated by: Anne H Berman, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet, department of clinical neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Internet help-seekers with problematic alcohol use.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow Back (TLFB)
Time Frame: 10 weeks
Quantity/frequency measure of alcohol consumption
10 weeks
The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 10 weeks
3 consumption questions and 7 problem-related questions regarding alcohol consumption
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Drug Use Disorders Identification Test (DUDIT)
Time Frame: 10 weeks
3 consumption questions and 7 problem-related questions regarding drug consumption
10 weeks
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: 10 weeks
14 questions, 7 on anxiety symptoms and 7 on depression symptoms
10 weeks
The Readiness to Change Questionnaire (RTCQ)
Time Frame: 10 weeks
12 questions rated from -2 to +2 and divided into 3 dimensions: precontemplation, contemplation and action
10 weeks
The Readiness Ruler
Time Frame: 10 weeks
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".
10 weeks
The World Health Quality of Life - shorter version (WHOQOL - BREF)
Time Frame: 10 weeks
26 questions measuring four domains of quality of life: physical, psychological, social and environment.
10 weeks
EQ-5D-5L
Time Frame: 10 weeks
5 questions on the following dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/discomfort
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 2, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/686-31/5
  • KI 2-1341/2014 (Other Identifier: Karolinska Institutet, Personal data act registrar)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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