Alcohol Use Disorders Clinical Trial
Official title:
Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
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.
Two Internet based programs based on cognitive behavioral therapy and relapse prevention are
evaluated among Internet help seekers, and compared to a waiting list. The design is a three
armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol
consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol
use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition
to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality
assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment
Credibility and Adverse Events will also be assessed, the former once during the third week
of treatment, and the latter once half way through treatment and once after treatment.
Primary hypothesis is that the more extended program with guidance (group 1) is more
effective in reducing mean alcohol consumption and number of heavy drinking days compared to
the briefer program with no guidance (group 2), as well as compared to a waiting list (group
3). A responder to treatment is defined as a participant drinking less than 9 (women)/
14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during
that week.
A minimum of 169 participants will be recruited in two phases: first through an online
screening and then through a diagnostic telephone assessment, where SCID will be used to
diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses.
The telephone assessment and all guidance will be conducted by licensed psychologists or
master students in psychology under supervision by licensed psychologists.
Included participants will be randomized into three groups:
Group 1: All participants in this group will have access to an extended cognitive behavioral
treatment program and have access to a guide with basic training in psychotherapy (CBT) who
assists and counsels the participant throughout the program.
Group 2: Participants in this group will have access to a briefer cognitive behavior
treatment program with no access to a guide.
Group 3: Participants in this group will be placed on a waiting list for 12 weeks.
Thereafter, they will be given access to the same extended cognitive behavior treatment
program as Group 1; they will also be offered a possibility to choose between three guidance
options: Choice 1: guide with intensive support, Choice 2: guide with support only at
request, Choice 3: no guide.
Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology
writing their MSc theses.
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