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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Stockholm, Sverige, 171 76
- Karolinska Institutet, department of clinical neuroscience
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcohol Use Identification Test (AUDIT)
Tidsramme: 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)
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Post, 3, 6 and 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time Line Follow Back (TLFB)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Drug Use Identification Test (DUDIT)
Tidsramme: Post, 3, 6 and 12 months
|
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
Tidsramme: Post
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Biological marker outcomes post-treatment.
B-PEth and CDT.
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Post
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Anne H Berman, PhD, Karolinska Institutet
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013/1391-31/5
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