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Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671019
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Kristina Sinadinovic, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date May 30, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 3 months post-randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 6 months post-randomization ]
  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 12 months post-randomization ]
  • Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 24 months post-randomization ]
  • Alcohol Use Disorders Identification Test score [ Time Frame: 3 months post-randomization ]
  • Alcohol Use Disorders Identification Test score [ Time Frame: 6 months post-randomization ]
  • Alcohol Use Disorders Identification Test score [ Time Frame: 12 months post-randomization ]
  • Alcohol Use Disorders Identification Test score [ Time Frame: 24 months post-randomization ]
  • Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 3 months post-randomization ]
  • Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 6 months post-randomization ]
  • Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 12 months post-randomization ]
  • Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 24 months post-randomization ]
  • Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 3 months post-randomization ]
  • Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 6 months post-randomization ]
  • Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 12 months post-randomization ]
  • Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 24 months post-randomization ]
  • Number of days absent from work due to illness [ Time Frame: 3 months post-randomization ]
  • Number of days absent from work due to illness [ Time Frame: 6 months post-randomization ]
  • Number of days absent from work due to illness [ Time Frame: 12 months post-randomization ]
  • Number of days absent from work due to illness [ Time Frame: 24 months post-randomization ]
  • Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 3 months post-randomization ]
  • Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 6 months post-randomization ]
  • Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 12 months post-randomization ]
  • Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 24 months post-randomization ]
  • Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 3 months post-randomization ]
  • Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 6 months post-randomization ]
  • Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 12 months post-randomization ]
  • Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 24 months post-randomization ]
  • Score on EQ-5D measuring the quality of life [ Time Frame: 3 months post-randomization ]
  • Score on EQ-5D measuring the quality of life [ Time Frame: 6 months post-randomization ]
  • Score on EQ-5D measuring the quality of life [ Time Frame: 12 months post-randomization ]
  • Score on EQ-5D measuring the quality of life [ Time Frame: 24 months post-randomization ]
  • Cost for treatment [ Time Frame: 3 months post-randomization ]
  • Cost for treatment [ Time Frame: 6 months post-randomization ]
  • Cost for treatment [ Time Frame: 12 months post-randomization ]
  • Cost for treatment [ Time Frame: 24 months post-randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
Official Title  ICMJE Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
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:

  1. 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.
  2. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorders
Intervention  ICMJE Behavioral: Guide to better alcohol habits
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.
Study Arms  ICMJE
  • Experimental: Internet-based treatment
    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.
    Intervention: Behavioral: Guide to better alcohol habits
  • Active Comparator: Face-to-face treatment
    Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
    Intervention: Behavioral: Guide to better alcohol habits
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
303
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
350
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671019
Other Study ID Numbers  ICMJE 2014/1758-31/2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristina Sinadinovic, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Stockholm County Council, Sweden
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP