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Anonymous Treatment on the Internet for Alcohol Dependence: A Randomised, Controlled Trial

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: NCT02377726
Recruitment Status : Active, not recruiting
First Posted : March 4, 2015
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Public Health Agency of Sweden
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

Brief Summary:
Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcohol Dependence Harmful Alcohol Use Alcohol Use Disorder Behavioral: Alkoholhjälpen counselor support Behavioral: eChange Alkoholhjälpen Behavioral: Alkoholhjälpen Not Applicable

Detailed Description:
A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Based Treatment for Alcohol Dependence Among Anonymous Help Seekers on the Internet : A Randomized Controlled Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet self-help with support
eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules. Patients will have access to Alkoholhjälpen counselor support through secure comments at every module they complete.
Behavioral: Alkoholhjälpen counselor support
Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.

Behavioral: eChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help

Experimental: Internet self-help
eChange Alkoholhjälpen is an internet based self help program consisting of 5 modules.
Behavioral: eChange Alkoholhjälpen
An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help

Active Comparator: Information
Brief information on resources that can be accessed through the open access website Alkoholhjälpen: Information on alcohol and health, where and how to find treatment and an internet discussion forum.
Behavioral: Alkoholhjälpen
A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum
Other Name: alcoholhjalpen.se, alcohol-help-site




Primary Outcome Measures :
  1. Time Line Follow Back (TLFB) (Change in total in consumption of alcohol last 7 days) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in total in consumption of alcohol last 7 days


Secondary Outcome Measures :
  1. Time Line Follow Back (TLFB) (Change in number of standard drinks per day during last 7 days) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in number of standard drinks per day during last 7 days

  2. Time Line Follow Back (TLFB) (Change in number of consumption days during last 7 days) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in number of consumption days during last 7 days

  3. Time Line Follow Back (TLFB) (Change in number of days binge-drinking days during last 7 days) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in number of days binge-drinking days during last 7 days

  4. Alcohol dependence (ICD-10) (Change in number of criteria for alcohol dependence met) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in number of criteria for alcohol dependence met

  5. Alcohol Use Disorder (DSM-5) (Change in number of criteria for alcohol use disorder met) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in number of criteria for alcohol use disorder met

  6. Alcohol Use Identification Test (AUDIT) (Change in total AUDIT score, as a summarized measure of alcohol use) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

  7. Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) (Change in total MADRS-S score) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in total MADRS-S score, as a summarized measure of depression

  8. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in total GAD-7 score, as a summarized measure of anxiety

  9. The EuroQol generic health index (EQ5D) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in total EQ5D score, as a summarized measure of quality of life

  10. Questions about help-seeking behavior [ Time Frame: 3, 6, 12 and 24 months ]
    Change in help-seeking for alcohol related problems from professionals

  11. Questions about help-seeking behavior (Change in help-seeking for alcohol related problems from family and friends) [ Time Frame: 3, 6, 12 and 24 months ]
    Change in help-seeking for alcohol related problems from family and friends


Other Outcome Measures:
  1. The Readiness Ruler (Scores between 0 and 100) [ Time Frame: 3, 6, 12 and 24 months ]
    Scores between 0 and 100. In this study, "I am not ready to change my drinking habits" and "I am very much ready to change my drinking habits".

  2. Use of Internet based program and website (Number of visits and number of completed exercises in the Internet based program and website) [ Time Frame: From baseline to 3 months ]
    Number of visits and number of completed exercises in the Internet based program and website

  3. Working alliance with internet based intervention (eSRS) (4 scale questions on the users alliance with the internet based intervention ) [ Time Frame: 2 and 5 weeks ]
    4 scale questions on the users alliance with the internet based intervention (program and/or website)



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:

AUDIT-score >16 points and/or at least 3 criteria of alcohol dependence (ICD-10)

Exclusion Criteria:

Inadequate Swedish language skills No Internet access


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): NCT02377726


Locations
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Sweden
Karolinska Institutet, Department of Public Health Sciences
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Public Health Agency of Sweden
Stockholm County Council, Sweden
Investigators
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Principal Investigator: Sven Andreasson, PhD Karolinska Institutet
Additional Information:
Publications:
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Responsible Party: Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02377726    
Other Study ID Numbers: 2014/1758-31-2
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Anne H Berman, Karolinska Institutet:
Randomized Controlled Trial
Alcohol
Internet
Internet based therapy
Cognitive behavioral therapy
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders