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Guided and Unguided Internet Treatment for Problematic Alcohol Use

Primary Purpose

Alcohol Abuse, Alcohol Addiction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Choice
Messages
Self help
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring randomized controlled trial, alcohol, internet, internet based therapy, cognitive behavior therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Choice

Messages

Self help

Arm Description

A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions

A self help program consisting of 8 modules. Patients will have access to therapist support through messages

A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support

Outcomes

Primary Outcome Measures

Time Line Follow Back (TLFB)
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption

Secondary Outcome Measures

Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Hamilton Anxiety and Depression Scale (HADS)
Change in total HADS score, as a summarized measure of depression and anxiety, respectively
EQ5
Change in total EQ5 score, as a summarized measure of quality of life
WHOQOL-BREF
Change in total WHOQOL-BREF score, as a summarized measure of quality of life

Full Information

First Posted
February 26, 2015
Last Updated
August 31, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02384304
Brief Title
Guided and Unguided Internet Treatment for Problematic Alcohol Use
Official Title
Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Addiction
Keywords
randomized controlled trial, alcohol, internet, internet based therapy, cognitive behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choice
Arm Type
Experimental
Arm Description
A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions
Arm Title
Messages
Arm Type
Experimental
Arm Description
A self help program consisting of 8 modules. Patients will have access to therapist support through messages
Arm Title
Self help
Arm Type
Active Comparator
Arm Description
A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support
Intervention Type
Behavioral
Intervention Name(s)
Choice
Intervention Description
A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions
Intervention Type
Behavioral
Intervention Name(s)
Messages
Intervention Description
A self help program consisting of 8 modules and access to therapist guidance through messages
Intervention Type
Behavioral
Intervention Name(s)
Self help
Intervention Description
A self help program consisting of 8 modules
Primary Outcome Measure Information:
Title
Time Line Follow Back (TLFB)
Description
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption
Time Frame
Baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Time Frame
Baseline and 10 weeks
Title
Hamilton Anxiety and Depression Scale (HADS)
Description
Change in total HADS score, as a summarized measure of depression and anxiety, respectively
Time Frame
Baseline and 10 weeks
Title
EQ5
Description
Change in total EQ5 score, as a summarized measure of quality of life
Time Frame
Baseline and 10 weeks
Title
WHOQOL-BREF
Description
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Time Frame
Baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
City
Stockholm
ZIP/Postal Code
11364
Country
Sweden

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
PubMed Identifier
27383389
Citation
Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.
Results Reference
derived
Links:
URL
http://ki.se/en/people/anberm
Description
Anne H Berman's research group profile

Learn more about this trial

Guided and Unguided Internet Treatment for Problematic Alcohol Use

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