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

Study Overview
=================
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).

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

Conditions
-----------------
Alcohol Abuse, Alcohol Addiction

Intervention / Treatment
-----------------
* Behavioral: eChange
* Behavioral: Face-to-face therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eChange web-based relapse prevention<br>A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system. | Behavioral: eChange<br>* A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system<br>|
| Active Comparator: Face-to-face therapy<br>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 | Behavioral: Face-to-face therapy<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow Back (TLFB) | Change in total TLFB score, as a summarized measure of alcohol consumption | Post, 3, 6 and 12 months | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy