Alcohol Use Disorders Clinical Trial
— ICBT-AUDOfficial title:
Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
NCT number | NCT02645721 |
Other study ID # | 2015/2014-31 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | June 2019 |
Verified date | June 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.
Status | Completed |
Enrollment | 166 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - = 18 years - access to the internet - consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week - AUDIT = 14 for females, = 16 for men - have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria) Exclusion Criteria: - insufficient Swedish skills - reading or writing difficulties, if it is to a degree that it will hamper the treatment - concurrent other psychological treatment with a content resembling treatments in this study - severe depression defined as a score of more than 30 on the MADRS-S - suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview - Drug use problems defined as = 8 p on the DUDIT - somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD) - has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time Line Follow Back | Number of standard drinks during preceding week (using the Time Line Follow Back) | Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment | |
Primary | Time Line Follow Back | Days of heavy drinking during preceding week (using the Time Line Follow Back) | Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment | |
Secondary | Alcohol Use Disorders Identification Test | assessement of alcohol use problems | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Alcohol Abstinence Self Efficacy Scale | instrument measuring self-efficacy | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Penn Alcohol Craving Scale | instrument measuring craving for alcohol | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Montgomery Asberg Depression Rating Scale | instrument measuring depression | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Euro-QOL 5 D | instrument measuring quality of life | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Generalized Anxiety Disorder-7 | instrument measuring anxiety | Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment | |
Secondary | Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P) | Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013 | Screening, 12 months, 24 months post-treatment | |
Secondary | Self-report questionnnaire on satisfaction with internet treatment usability features | This instrument contains 40 questions about satisfaction with various features of the internet-based treatment. Results will be analyzed on an aggregated group level. The questionnaire was constructed by the Internet psychiatry clinic in Stockholm. | Post-treatment (12 weeks after before-treatment measure) | |
Secondary | Adult ADHD Self Report Scale (ASRS) | Screening of ADHD symptoms to be used as predictor of treatment outcome | Screening | |
Secondary | Health-relevant Personality traits from a Five-factor perspective (hp5i) | Screening of personality traits to be used as predictor of treatment outcome | Screening | |
Secondary | Adverse Events | Brief questionnaire with questions about any negative side effects of the treatment | Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure) | |
Secondary | Treatment Credibility Scale | Brief questionnaire about if the treatment this far is perceived as effective | 3 weeks after before-treatment measure | |
Secondary | SCID- section of Alcohol Use Disorders (adjusted to DSM5) | Diagnostic interview via telephone, diagnostic criteria of Alcohol Use Disorders (this will be undertaken if resurces allow). This will be a masked assessment, the interviewer will not know which original group the participant was randomized to | Screening interview, 12 and 24 months post-treatment |
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