NCT02283593

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,165

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

November 2, 2014

Last Update Submit

August 31, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Timeline Follow Back (TLFB)

    Quantity/frequency measure of alcohol consumption

    10 weeks

  • The Alcohol Use Disorders Identification Test (AUDIT)

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

    10 weeks

Secondary Outcomes (6)

  • The Drug Use Disorders Identification Test (DUDIT)

    10 weeks

  • The Hospital Anxiety and Depression Scale (HADS)

    10 weeks

  • The Readiness to Change Questionnaire (RTCQ)

    10 weeks

  • The Readiness Ruler

    10 weeks

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

    10 weeks

  • +1 more secondary outcomes

Interventions

eChange.seBEHAVIORAL

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

Also known as: SO (Self-help online, see Blankers et al., 2011)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Internet help-seekers with problematic alcohol use.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Department of Clinical Neuroscience

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25300885BACKGROUND

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2014

First Posted

November 5, 2014

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations