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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

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.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorders Behavioral: Guide to better alcohol habits Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 6 months post-randomization ]
  2. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 12 months post-randomization ]
  3. Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method [ Time Frame: 24 months post-randomization ]
  4. Alcohol Use Disorders Identification Test score [ Time Frame: 3 months post-randomization ]
  5. Alcohol Use Disorders Identification Test score [ Time Frame: 6 months post-randomization ]
  6. Alcohol Use Disorders Identification Test score [ Time Frame: 12 months post-randomization ]
  7. Alcohol Use Disorders Identification Test score [ Time Frame: 24 months post-randomization ]
  8. Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 3 months post-randomization ]
  9. Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 6 months post-randomization ]
  10. Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 12 months post-randomization ]
  11. Number of criteria for alcohol dependence according to International Classification of Diseases - 10 [ Time Frame: 24 months post-randomization ]
  12. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 3 months post-randomization ]
  13. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 6 months post-randomization ]
  14. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 12 months post-randomization ]
  15. Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V [ Time Frame: 24 months post-randomization ]
  16. Number of days absent from work due to illness [ Time Frame: 3 months post-randomization ]
  17. Number of days absent from work due to illness [ Time Frame: 6 months post-randomization ]
  18. Number of days absent from work due to illness [ Time Frame: 12 months post-randomization ]
  19. Number of days absent from work due to illness [ Time Frame: 24 months post-randomization ]
  20. Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 3 months post-randomization ]
  21. Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 6 months post-randomization ]
  22. Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 12 months post-randomization ]
  23. Score on Montgomery-Åsberg Depression Rating Scale [ Time Frame: 24 months post-randomization ]
  24. Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 3 months post-randomization ]
  25. Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 6 months post-randomization ]
  26. Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 12 months post-randomization ]
  27. Score on Generalised Anxiety Disorder 7-item scale [ Time Frame: 24 months post-randomization ]
  28. Score on EQ-5D measuring the quality of life [ Time Frame: 3 months post-randomization ]
  29. Score on EQ-5D measuring the quality of life [ Time Frame: 6 months post-randomization ]
  30. Score on EQ-5D measuring the quality of life [ Time Frame: 12 months post-randomization ]
  31. Score on EQ-5D measuring the quality of life [ Time Frame: 24 months post-randomization ]
  32. Cost for treatment [ Time Frame: 3 months post-randomization ]
  33. Cost for treatment [ Time Frame: 6 months post-randomization ]
  34. Cost for treatment [ Time Frame: 12 months post-randomization ]
  35. Cost for treatment [ Time Frame: 24 months post-randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671019


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
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Responsible Party: Kristina Sinadinovic, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02671019    
Other Study ID Numbers: 2014/1758-31/2
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders