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

Problematic Alcohol Use Clinical Trial

— eChangeNAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283593
• Other study ID #: 2013/686-31/5
• Secondary ID: KI 2-1341/2014
• Status: Completed
• Phase: N/A
• First received: November 2, 2014
• Last updated: August 31, 2015
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review BoardSweden: Swedish Data Inspection BoardSweden: Karolinska Institutet: The Swedish Personal Data Act Registrar
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4165
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcohol Drinking
• Problematic Alcohol Use

Intervention

Behavioral:
• eChange.se
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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Neuroscience	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow Back (TLFB)	Quantity/frequency measure of alcohol consumption	10 weeks	No
Primary	The Alcohol Use Disorders Identification Test (AUDIT)	3 consumption questions and 7 problem-related questions regarding alcohol consumption	10 weeks	No
Secondary	The Drug Use Disorders Identification Test (DUDIT)	3 consumption questions and 7 problem-related questions regarding drug consumption	10 weeks	No
Secondary	The Hospital Anxiety and Depression Scale (HADS)	14 questions, 7 on anxiety symptoms and 7 on depression symptoms	10 weeks	No
Secondary	The Readiness to Change Questionnaire (RTCQ)	12 questions rated from -2 to +2 and divided into 3 dimensions: precontemplation, contemplation and action	10 weeks	No
Secondary	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".	10 weeks	No
Secondary	The World Health Quality of Life - shorter version (WHOQOL - BREF)	26 questions measuring four domains of quality of life: physical, psychological, social and environment.	10 weeks	No
Secondary	EQ-5D-5L	5 questions on the following dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/discomfort	10 weeks	No