Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program (FoBeMA)
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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Stockholm, Sverige, 171 76
- Karolinska Institutet, department of clinical neuroscience
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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A web-based relapse intervention program consisting of 14 modules.
The patient will have access to therapist support through a secure messaging system
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Aktiv komparator: 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
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Alcohol Use Identification Test (AUDIT)
Tidsram: Post, 3, 6 and 12 months
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Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
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Post, 3, 6 and 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time Line Follow Back (TLFB)
Tidsram: Post, 3, 6 and 12 months
|
Change in total TLFB score, as a summarized measure of alcohol consumption
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Post, 3, 6 and 12 months
|
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Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Tidsram: Post, 3, 6 and 12 months
|
Change in total MADRS-S score, as a summarized measure of depression
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Post, 3, 6 and 12 months
|
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World Health Quality of Life Scale (WHOQOL-BREF)
Tidsram: Post, 3, 6 and 12 months
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Change in total WHOQOL-BREF score, as a summarized measure of quality of life
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Post, 3, 6 and 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Drug Use Identification Test (DUDIT)
Tidsram: Post, 3, 6 and 12 months
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Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems)
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Post, 3, 6 and 12 months
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Biological tests for alcohol markers
Tidsram: Post
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Biological marker outcomes post-treatment.
B-PEth and CDT.
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Post
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Anne H Berman, PhD, Karolinska Institutet
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2013/1391-31/5
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