Alcohol Use Disorders Clinical Trial
— ICBT-APOfficial title:
Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study
| NCT number | NCT02384278 |
| Other study ID # | ID10 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | July 2017 |
| Verified date | August 2019 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | July 2017 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - = 18 years - access to the Internet - problematic alcohol use defined as = 16 p or more for men and = 14 p or more for women in the Alcohol Use Identification Scale Exclusion Criteria: - not adequately fluent in Swedish - reading or writing impairment if this is so severe as to affect treatment - ongoing psychological treatment with content similar to the treatment being studied - suicide risk defined as = 4 p på MADRS-S Q 9 or through a telephone interview with clinician - severe depression defined as MADRS-S = 30 p - somatic or psychiatric conditions that are contraindicated for the treatment such as psychosis, bipolar disorder (depressive or manic phase), severe post traumatic stress disorder. - has during the last 3 weeks begun using medication for alcohol problems or other psychiatric disorder |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Göteborg University |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time Line Follow Back (TLFB) | Change in total TLFB score (consumption during preceding week), as a summarized | Baseline, 14 and 26 weeks | |
| Secondary | Alcohol Use Disorders Identification Test (AUDIT) | Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems) | Baseline, 14 and 26 weeks | |
| Secondary | Drug Use Identification Test (DUDIT) | Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems) | Baseline, 14 and 26 weeks | |
| Secondary | Montgomery Asberg Depression Rating Scale - self report (MADRS-S) | Change in total MADRS-S score, as a summarized measure of depression | Baseline, 14 and 26 weeks | |
| Secondary | World Health Organization Quality of Life Scale (WHOQOL-BREF) | Change in total WHOQOL-BREF score, as a summarized measure of quality of life | Baseline, 14 and 26 weeks | |
| Secondary | Alcohol Abstinence Self Efficacy Scale (AASES) | Change in total AASES score, as a summarized measure of self efficacy | Baseline, 14 and 26 weeks | |
| Secondary | Penn Alcohol Craving Scale (PACS) | Baseline, 14 and 26 weeks | ||
| Secondary | Readiness to Change Questionnaire (RTCQ) | Score in RTCQ as a summarized measure of motivation used as predictor for other outcomes | Baseline, 14 and 26 weeks |
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