search
Back to results

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

Primary Purpose

Alcohol Abuse, Alcohol Addiction

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
eChange
Face-to-face therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska institutet, Department of Clinical Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eChange web-based relapse prevention

Face-to-face therapy

Arm Description

A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.

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

Outcomes

Primary Outcome Measures

Alcohol Use Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2013
Last Updated
March 14, 2016
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT02014779
Brief Title
Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Only 1 participant recruited to study. Qs addressed in other ongoing studies.
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Addiction
Keywords
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eChange web-based relapse prevention
Arm Type
Experimental
Arm Description
A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system.
Arm Title
Face-to-face therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
eChange
Intervention Description
A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Alcohol Use Identification Test (AUDIT)
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Time Frame
Post, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Time Line Follow Back (TLFB)
Description
Change in total TLFB score, as a summarized measure of alcohol consumption
Time Frame
Post, 3, 6 and 12 months
Title
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Description
Change in total MADRS-S score, as a summarized measure of depression
Time Frame
Post, 3, 6 and 12 months
Title
World Health Quality of Life Scale (WHOQOL-BREF)
Description
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Time Frame
Post, 3, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Drug Use Identification Test (DUDIT)
Description
Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems)
Time Frame
Post, 3, 6 and 12 months
Title
Biological tests for alcohol markers
Description
Biological marker outcomes post-treatment. B-PEth and CDT.
Time Frame
Post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institutet, Department of Clinical Neuroscience
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://ki.se/people/anberm
Description
Anne H Berman's research group profile

Learn more about this trial

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

We'll reach out to this number within 24 hrs