Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
Primary Purpose
Alcohol Use Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Guide to better alcohol habits
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorders
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- Resident in Stockholm County
Exclusion Criteria:
- Lack of understanding of the Swedish language.
- Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- Doctor's assessment that there is a need for medication for alcohol dependence.
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet-based treatment
Face-to-face treatment
Arm Description
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Outcomes
Primary Outcome Measures
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Secondary Outcome Measures
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Alcohol Use Disorders Identification Test score
Alcohol Use Disorders Identification Test score
Alcohol Use Disorders Identification Test score
Alcohol Use Disorders Identification Test score
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Number of days absent from work due to illness
Number of days absent from work due to illness
Number of days absent from work due to illness
Number of days absent from work due to illness
Score on Montgomery-Åsberg Depression Rating Scale
Score on Montgomery-Åsberg Depression Rating Scale
Score on Montgomery-Åsberg Depression Rating Scale
Score on Montgomery-Åsberg Depression Rating Scale
Score on Generalised Anxiety Disorder 7-item scale
Score on Generalised Anxiety Disorder 7-item scale
Score on Generalised Anxiety Disorder 7-item scale
Score on Generalised Anxiety Disorder 7-item scale
Score on EQ-5D measuring the quality of life
Score on EQ-5D measuring the quality of life
Score on EQ-5D measuring the quality of life
Score on EQ-5D measuring the quality of life
Cost for treatment
Cost for treatment
Cost for treatment
Cost for treatment
Full Information
NCT ID
NCT02671019
First Posted
January 11, 2016
Last Updated
May 29, 2019
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT02671019
Brief Title
Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
Official Title
Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based treatment
Arm Type
Experimental
Arm Description
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Arm Title
Face-to-face treatment
Arm Type
Active Comparator
Arm Description
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Intervention Type
Behavioral
Intervention Name(s)
Guide to better alcohol habits
Intervention Description
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Primary Outcome Measure Information:
Title
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time Frame
3 months post-randomization
Secondary Outcome Measure Information:
Title
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time Frame
6 months post-randomization
Title
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time Frame
12 months post-randomization
Title
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Time Frame
24 months post-randomization
Title
Alcohol Use Disorders Identification Test score
Time Frame
3 months post-randomization
Title
Alcohol Use Disorders Identification Test score
Time Frame
6 months post-randomization
Title
Alcohol Use Disorders Identification Test score
Time Frame
12 months post-randomization
Title
Alcohol Use Disorders Identification Test score
Time Frame
24 months post-randomization
Title
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time Frame
3 months post-randomization
Title
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time Frame
6 months post-randomization
Title
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time Frame
12 months post-randomization
Title
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Time Frame
24 months post-randomization
Title
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time Frame
3 months post-randomization
Title
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time Frame
6 months post-randomization
Title
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time Frame
12 months post-randomization
Title
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Time Frame
24 months post-randomization
Title
Number of days absent from work due to illness
Time Frame
3 months post-randomization
Title
Number of days absent from work due to illness
Time Frame
6 months post-randomization
Title
Number of days absent from work due to illness
Time Frame
12 months post-randomization
Title
Number of days absent from work due to illness
Time Frame
24 months post-randomization
Title
Score on Montgomery-Åsberg Depression Rating Scale
Time Frame
3 months post-randomization
Title
Score on Montgomery-Åsberg Depression Rating Scale
Time Frame
6 months post-randomization
Title
Score on Montgomery-Åsberg Depression Rating Scale
Time Frame
12 months post-randomization
Title
Score on Montgomery-Åsberg Depression Rating Scale
Time Frame
24 months post-randomization
Title
Score on Generalised Anxiety Disorder 7-item scale
Time Frame
3 months post-randomization
Title
Score on Generalised Anxiety Disorder 7-item scale
Time Frame
6 months post-randomization
Title
Score on Generalised Anxiety Disorder 7-item scale
Time Frame
12 months post-randomization
Title
Score on Generalised Anxiety Disorder 7-item scale
Time Frame
24 months post-randomization
Title
Score on EQ-5D measuring the quality of life
Time Frame
3 months post-randomization
Title
Score on EQ-5D measuring the quality of life
Time Frame
6 months post-randomization
Title
Score on EQ-5D measuring the quality of life
Time Frame
12 months post-randomization
Title
Score on EQ-5D measuring the quality of life
Time Frame
24 months post-randomization
Title
Cost for treatment
Time Frame
3 months post-randomization
Title
Cost for treatment
Time Frame
6 months post-randomization
Title
Cost for treatment
Time Frame
12 months post-randomization
Title
Cost for treatment
Time Frame
24 months post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
Resident in Stockholm County
Exclusion Criteria:
Lack of understanding of the Swedish language.
Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
Doctor's assessment that there is a need for medication for alcohol dependence.
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
We'll reach out to this number within 24 hrs