Internet Based Cognitive Behavior Treatment for Alcohol Problems (ICBT-AP)

August 12, 2019 updated by: Anne H Berman, Karolinska Institutet

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11364
        • Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based CBT for alcohol problems
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.
Behavioral: Internet-based CBT for alcohol problems
A 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Line Follow Back (TLFB)
Time Frame: Baseline, 14 and 26 weeks
Change in total TLFB score (consumption during preceding week), as a summarized
Baseline, 14 and 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Baseline, 14 and 26 weeks
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Baseline, 14 and 26 weeks
Drug Use Identification Test (DUDIT)
Time Frame: Baseline, 14 and 26 weeks
Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems)
Baseline, 14 and 26 weeks
Montgomery Asberg Depression Rating Scale - self report (MADRS-S)
Time Frame: Baseline, 14 and 26 weeks
Change in total MADRS-S score, as a summarized measure of depression
Baseline, 14 and 26 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time Frame: Baseline, 14 and 26 weeks
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Baseline, 14 and 26 weeks
Alcohol Abstinence Self Efficacy Scale (AASES)
Time Frame: Baseline, 14 and 26 weeks
Change in total AASES score, as a summarized measure of self efficacy
Baseline, 14 and 26 weeks
Penn Alcohol Craving Scale (PACS)
Time Frame: Baseline, 14 and 26 weeks
Baseline, 14 and 26 weeks
Readiness to Change Questionnaire (RTCQ)
Time Frame: Baseline, 14 and 26 weeks
Score in RTCQ as a summarized measure of motivation used as predictor for other outcomes
Baseline, 14 and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The dataset, unidentified, with background characteristics and outcomes is available as below.

IPD Sharing Time Frame

Since January 31, 2017

IPD Sharing Access Criteria

Availability of data and materials

The data set supporting the results of this article is available in the Open ICPSR repository with the following identifying information: Berman, A. H. (2017-01-31). High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorders - a pilot study. [Data set]. Ann Arbor, MI:

Inter-university Consortium of Political and Social Research [distributor]. http://doi.org/10.3886/E100415V1.

IPD Sharing Supporting Information Type

  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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