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

March 14, 2016 updated by: Anne H Berman, Karolinska Institutet

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Institutet, department of clinical neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eChange web-based relapse prevention
A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.
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
Active Comparator: 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
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Identification Test (AUDIT)
Time Frame: 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)
Post, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Line Follow Back (TLFB)
Time Frame: Post, 3, 6 and 12 months
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)
Time Frame: Post, 3, 6 and 12 months
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)
Time Frame: Post, 3, 6 and 12 months
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Post, 3, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Use Identification Test (DUDIT)
Time Frame: Post, 3, 6 and 12 months
Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems)
Post, 3, 6 and 12 months
Biological tests for alcohol markers
Time Frame: Post
Biological marker outcomes post-treatment. B-PEth and CDT.
Post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 18, 2013

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1391-31/5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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