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Clinical Trials/NCT02384278
NCT02384278CompletedNot Applicable

Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study

Karolinska Institutet1 site in 1 country13 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
Time Line Follow Back (TLFB)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Internet-based CBT for alcohol problems

Experimental

A 12-week internet-based cognitive behavior treatment (CBT) and relapse prevention program. The subjects will have access to a psychologist guiding them through the program.

Intervention: Internet-based CBT for alcohol problems (Behavioral)

Outcomes

Primary Outcomes

Time Line Follow Back (TLFB)

Time Frame: Baseline, 14 and 26 weeks

Change in total TLFB score (consumption during preceding week), as a summarized

Secondary Outcomes

  • World Health Organization Quality of Life Scale (WHOQOL-BREF)(Baseline, 14 and 26 weeks)
  • Alcohol Abstinence Self Efficacy Scale (AASES)(Baseline, 14 and 26 weeks)
  • Alcohol Use Disorders Identification Test (AUDIT)(Baseline, 14 and 26 weeks)
  • Drug Use Identification Test (DUDIT)(Baseline, 14 and 26 weeks)
  • Montgomery Asberg Depression Rating Scale - self report (MADRS-S)(Baseline, 14 and 26 weeks)
  • Readiness to Change Questionnaire (RTCQ)(Baseline, 14 and 26 weeks)
  • Penn Alcohol Craving Scale (PACS)(Baseline, 14 and 26 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne H Berman

Associate Professor

Karolinska Institutet

Study Sites (1)

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