Alcohol Abuse, Alcohol Addiction
Conditions
Keywords
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy
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).
Interventions
BEHAVIORALeChange
A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system
BEHAVIORALFace-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
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Identification Test (AUDIT) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Line Follow Back (TLFB) | Post, 3, 6 and 12 months | Change in total TLFB score, as a summarized measure of alcohol consumption |
| Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) | Post, 3, 6 and 12 months | Change in total MADRS-S score, as a summarized measure of depression |
| World Health Quality of Life Scale (WHOQOL-BREF) | Post, 3, 6 and 12 months | Change in total WHOQOL-BREF score, as a summarized measure of quality of life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biological tests for alcohol markers | Post | Biological marker outcomes post-treatment. B-PEth and CDT. |
| Drug Use Identification Test (DUDIT) | Post, 3, 6 and 12 months | Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems) |
Countries
Sweden
Outcome results
None listed