Alcohol Use Disorders
Conditions
Brief summary
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that: 1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment. 2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment. The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups: Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program. Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
Interventions
BEHAVIORALGuide to better alcohol habits
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence * Resident in Stockholm County
Exclusion criteria
* Lack of understanding of the Swedish language. * Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care. * Doctor's assessment that there is a need for medication for alcohol dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method | 3 months post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method | 6 months post-randomization |
| Alcohol Use Disorders Identification Test score | 3 months post-randomization |
| Number of criteria for alcohol dependence according to International Classification of Diseases - 10 | 3 months post-randomization |
| Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V | 3 months post-randomization |
| Number of days absent from work due to illness | 3 months post-randomization |
| Score on Montgomery-Åsberg Depression Rating Scale | 3 months post-randomization |
| Score on Generalised Anxiety Disorder 7-item scale | 3 months post-randomization |
| Score on EQ-5D measuring the quality of life | 3 months post-randomization |
| Cost for treatment | 3 months post-randomization |
Countries
Sweden
Outcome results
None listed