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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2019
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.


Description:

A 12 week Internet based self help program based on cognitive behavioral therapy and relapse prevention is tested among Internet help seekers as well as among patients seeking help in addiction care.The design is a one armed pilot study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, self efficacy, craving, as well as depression and quality of life. 20 participants are recruited entirely online from an open access website and 20 participants are recruited through information given to them at an addiction clinic. All participants have access to the same self help program and have access to a licensed psychologist who guides the person all the way through the program.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet-based CBT for alcohol problems
A 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention

Locations

Country Name City State
Sweden Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

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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