Guided and Unguided Internet Treatment for Problematic Alcohol Use

Alcohol Abuse Clinical Trial

Official title:

Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384304
• Other study ID #: 2012/1761-31/5
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: August 31, 2015
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

Description:

Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years

• access to the Internet

• problematic alcohol use defined as = 8 p or more for men and = 6 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

• not adequately fluent in Swedish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Addiction
• Alcoholism

Intervention

Behavioral:
• Choice
A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions
• Messages
A self help program consisting of 8 modules and access to therapist guidance through messages
• Self help
A self help program consisting of 8 modules

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Line Follow Back (TLFB)	Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption	Baseline and 10 weeks	No
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)	Baseline and 10 weeks	No
Secondary	Hamilton Anxiety and Depression Scale (HADS)	Change in total HADS score, as a summarized measure of depression and anxiety, respectively	Baseline and 10 weeks	No
Secondary	EQ5	Change in total EQ5 score, as a summarized measure of quality of life	Baseline and 10 weeks	No
Secondary	WHOQOL-BREF	Change in total WHOQOL-BREF score, as a summarized measure of quality of life	Baseline and 10 weeks	No

External Links

•   Anne H Berman's research group profile