Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program

Alcohol Abuse Clinical Trial

— FoBeMA  

Official title:

Internet-Based Relapse Prevention With Therapist Support vs Face to Face Therapy at an Employee Assistance Program: A Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02014779
• Other study ID #: 2013/1391-31/5
• Status: Terminated
• Phase: N/A
• First received: December 12, 2013
• Last updated: March 14, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection BoardSweden: Personal Data Act
• Study type: Interventional

Clinical Trial Summary

Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life.

Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.

Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.

Exclusion Criteria:

Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Addiction
• Alcoholism

Intervention

Behavioral:
• eChange
A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system
• Face-to-face therapy
Face-to-face psychotherapy, consisting of 20 sessions. The content will be different for different therapists, but all have an evidence based approach to therapy

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug Use Identification Test (DUDIT)	Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems)	Post, 3, 6 and 12 months	No
Other	Biological tests for alcohol markers	Biological marker outcomes post-treatment. B-PEth and CDT.	Post	No
Primary	Alcohol Use Identification Test (AUDIT)	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)	Post, 3, 6 and 12 months	No
Secondary	Time Line Follow Back (TLFB)	Change in total TLFB score, as a summarized measure of alcohol consumption	Post, 3, 6 and 12 months	No
Secondary	Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)	Change in total MADRS-S score, as a summarized measure of depression	Post, 3, 6 and 12 months	No
Secondary	World Health Quality of Life Scale (WHOQOL-BREF)	Change in total WHOQOL-BREF score, as a summarized measure of quality of life	Post, 3, 6 and 12 months	No

External Links

•   Anne H Berman's research group profile