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

Not Applicable

Terminated

• Conditions: Alcohol Abuse; Alcohol Addiction
• Interventions: Behavioral: eChange; Behavioral: Face-to-face therapy

• Registration Number: NCT02014779
• Lead Sponsor: Karolinska Institutet

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-01
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eChange web-based relapse prevention	eChange	A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.
Face-to-face therapy	Face-to-face therapy	Face-to-face psychotherapy, consisting of 20 sessions. The content will be vary for different therapists, but all have an evidence-based approach to therapy

Primary Outcome Measures

Name	Time	Method
Alcohol Use Identification Test (AUDIT)	Post, 3, 6 and 12 months	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

Secondary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB)	Post, 3, 6 and 12 months	Change in total TLFB score, as a summarized measure of alcohol consumption
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)	Post, 3, 6 and 12 months	Change in total MADRS-S score, as a summarized measure of depression
World Health Quality of Life Scale (WHOQOL-BREF)	Post, 3, 6 and 12 months	Change in total WHOQOL-BREF score, as a summarized measure of quality of life

Trial Locations

Locations (1)

Karolinska institutet, Department of Clinical Neuroscience; 🇸🇪 Stockholm, Sweden