Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder, Harmful Alcohol Use
Conditions
Keywords
Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy
Brief summary
Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.
Detailed description
A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.
Interventions
BEHAVIORALAlkoholhjälpen counselor support
Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.
BEHAVIORALeChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
BEHAVIORALAlkoholhjälpen
A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum
Sponsors
Public Health Agency of Sweden
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
AUDIT-score \>16 points and/or at least 3 criteria of alcohol dependence (ICD-10)
Exclusion criteria
Inadequate Swedish language skills No Internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days) | 3, 6, 12 and 24 months | Change in total in consumption of alcohol last 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met) | 3, 6, 12 and 24 months | Change in number of criteria for alcohol use disorder met |
| The EuroQol generic health index (EQ5D) | 3, 6, 12 and 24 months | Change in total EQ5D score, as a summarized measure of quality of life |
| Questions about help-seeking behavior | 3, 6, 12 and 24 months | Change in help-seeking for alcohol related problems from professionals |
| Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends) | 3, 6, 12 and 24 months | Change in help-seeking for alcohol related problems from family and friends |
| Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days) | 3, 6, 12 and 24 months | Change in number of standard drinks per day during last 7 days |
| Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days) | 3, 6, 12 and 24 months | Change in number of consumption days during last 7 days |
| Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days) | 3, 6, 12 and 24 months | Change in number of days binge-drinking days during last 7 days |
| Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met) | 3, 6, 12 and 24 months | Change in number of criteria for alcohol dependence met |
| Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use) | 3, 6, 12 and 24 months | Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems) |
| Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score) | 3, 6, 12 and 24 months | Change in total MADRS-S score, as a summarized measure of depression |
| Generalised Anxiety Disorder Assessment (GAD-7) | 3, 6, 12 and 24 months | Change in total GAD-7 score, as a summarized measure of anxiety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention ) | 2 and 5 weeks | 4 scale questions on the users alliance with the internet based intervention (program and/or website) |
| The Readiness Ruler (Scores between 0 and 100) | 3, 6, 12 and 24 months | Scores between 0 and 100. In this study, I am not ready to change my drinking habits and I am very much ready to change my drinking habits. |
| Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website) | From baseline to 3 months | Number of visits and number of completed exercises in the Internet based program and website |
Countries
Sweden
Outcome results
None listed