Clinical trial NCT02384278: Internet Based Cognitive Behavior Treatment for Alcohol Problems
Official title: Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorders
Keywords: alcohol use disorder
internet
cognitive behavior therapy
relapse prevention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2015-03-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Line Follow Back (TLFB)
timeFrame: Baseline, 14 and 26 weeks
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, 14 and 26 weeks
measure: Drug Use Identification Test (DUDIT)
timeFrame: Baseline, 14 and 26 weeks
measure: Montgomery Asberg Depression Rating Scale - self report (MADRS-S)
timeFrame: Baseline, 14 and 26 weeks
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: Baseline, 14 and 26 weeks
measure: Alcohol Abstinence Self Efficacy Scale (AASES)
timeFrame: Baseline, 14 and 26 weeks
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: Baseline, 14 and 26 weeks
measure: Readiness to Change Questionnaire (RTCQ)
timeFrame: Baseline, 14 and 26 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6.