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Guided and Unguided Internet Treatment for Problematic Alcohol Use

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: NCT02384304
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

Brief Summary:
The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcohol Addiction Behavioral: Choice Behavioral: Messages Behavioral: Self help Not Applicable

Detailed Description:
Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
Study Start Date : December 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Choice
A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions
Behavioral: Choice
A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions

Experimental: Messages
A self help program consisting of 8 modules. Patients will have access to therapist support through messages
Behavioral: Messages
A self help program consisting of 8 modules and access to therapist guidance through messages

Active Comparator: Self help
A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support
Behavioral: Self help
A self help program consisting of 8 modules




Primary Outcome Measures :
  1. Time Line Follow Back (TLFB) [ Time Frame: Baseline and 10 weeks ]
    Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline and 10 weeks ]
    Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)

  2. Hamilton Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and 10 weeks ]
    Change in total HADS score, as a summarized measure of depression and anxiety, respectively

  3. EQ5 [ Time Frame: Baseline and 10 weeks ]
    Change in total EQ5 score, as a summarized measure of quality of life

  4. WHOQOL-BREF [ Time Frame: Baseline and 10 weeks ]
    Change in total WHOQOL-BREF score, as a summarized measure of quality of life



Information from the National Library of Medicine

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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
  • access to the Internet
  • problematic alcohol use defined as ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale

Exclusion Criteria:

• not adequately fluent in Swedish


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): NCT02384304


Locations
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Sweden
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Stockholm, Sweden, 11364
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Anne H Berman, PhD Karolinska Institutet
Additional Information:
Publications:
Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne H Berman, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02384304    
Other Study ID Numbers: 2012/1761-31/5
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Anne H Berman, Karolinska Institutet:
randomized controlled trial
alcohol
internet
internet based therapy
cognitive behavior therapy
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders