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Skills-training for Reducing Risky Alcohol Use in App Form

Primary Purpose

Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Telecoach
TeleCoach control
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, Internet, Mobile phone, Smartphone, App, Alcohol, Substance use

Eligibility Criteria

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

Inclusion Criteria:

  • ≥ 18 years
  • Risky alcohol consumption defined as Alcohol Use Disorders Identification Test (AUDIT) scores of ≥6 points for women and ≥ 8 points for men.

Exclusion Criteria:

  • Severe depression, defined as a MADRS-S score of > 30
  • Sucide risk, defined as a MADRS-S, item 9 (Lust for life) score > 4
  • Drug abuse, defined as a score of ≥ 8 on the DUDIT

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telecoach

TeleCoach control

Arm Description

A skills-training web-app teaching skills for reducing problematic alcohol use.

A web-app giving information on health-related consequences of alcohol consumption.

Outcomes

Primary Outcome Measures

Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.

Secondary Outcome Measures

Daily Drinking Questionnaire (DDQ)
The number of standard glasses (12g of ethanol) consumed and over how many hours for each day of a typical week the last month.
Alcohol Use Disorders Identification Test (AUDIT)
10 questions measuring alcohol consumption and alcohol-related problems.
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.
Readiness Ruler
A visual analogue scale measuring participants' motivation to change their alcohol consumption.
DSM-5 Alcohol use disorder criteria.
Criteria for the diagnosis Alcohol use disorder in the the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Penn Alcohol Craving Scale (PACS)
5 items to measure participants' craving for alcohol.
Alcohol Abstinence Self Efficacy scale (AASE)
12 items for measuring self efficacy in the domain of abstaining from drinking alcohol.
Drug Use Disorders Identification Test (DUDIT)
11 items for measuring participants' drug consumption and drug-related problems.
Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)
9 questions measuring symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
7 questions measuring symptoms of anxiety
Treatment questions (7 questions regarding access to other help and support for problematic alcohol use).
7 questions regarding access to other help and support for problematic alcohol use.
Usability questions regarding the participants' experience of using the web-app they were assigned.
Questions regarding the participants' experience of using the web-app they were assigned.

Full Information

First Posted
October 2, 2018
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03696888
Brief Title
Skills-training for Reducing Risky Alcohol Use in App Form
Official Title
Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. The Telecoach web app delivers skills training in the form of exercises commonly used in psychosocial interventions for risky alcohol use. The controll condition is a web app providing information on the effects of alcohol on the consumers' health.
Detailed Description
This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. Individuals seeking help for problematic alcohol use on the internet will get access to a webpage with information about the study. Individuals leaving informed consent are asked to fill out questionnaires about alcohol use, depression, anxiety and information on gender and weight. Those with excessive alcohol use (>14 standard glasses/week for men and > 9 for women) are randomized into one of two groups: 1. Access to the Telecoach web-app and 2. Access to a control condition with an information-providing web-app. Outcomes on alcohol use are gathered by electronic self-registration at 6, 12 and 26 weeks after study initiation. Additional questions on the users' satisfaction with the app assigned to them and other support for problematic alcohol used during the research period at 26 weeks. The Telecoach web-app is a skills-training app developed for use on a mobile smart-phone. The skills-training components are common to psychosocial treatment protocols for problematic alcohol consumption. The control condition web-app is a simple text-based app providing information on the effects of alcohol on the consumers' health. Outcomes will be reported, analyzed and discussed in a scientific article.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Use Disorder, Alcohol Drinking, Alcohol Dependence, Alcohol; Harmful Use
Keywords
Randomized Controlled Trial, Internet, Mobile phone, Smartphone, App, Alcohol, Substance use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Note: A pilot period with interim 6-week analyses following recruitment of about 10% of the maximum anticipated sample of 1000 is part of the study. This offers an opportunity to assess trial continuation from an ethical perspective. The rationale for this is that individuals with relatively severe levels of alcohol use can be included in the trial and the investigators harbor a concern that the components in the intervention and control conditions might be insufficient to support the participants in remaining stable or reducing their alcohol intake. The pilot period covers a recruitment period from Dec 7, 2019 to February 15, 2019 (n=89) and includes a 6-week follow-up. The interim analysis from May 1, 2019 indicates group declines in alcohol use over the 6-week follow-up period for both conditions, suggesting that continuation of the trial is warranted. Pilot participants will be included in the final study sample.
Masking
Participant
Allocation
Randomized
Enrollment
678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telecoach
Arm Type
Experimental
Arm Description
A skills-training web-app teaching skills for reducing problematic alcohol use.
Arm Title
TeleCoach control
Arm Type
Active Comparator
Arm Description
A web-app giving information on health-related consequences of alcohol consumption.
Intervention Type
Behavioral
Intervention Name(s)
Telecoach
Intervention Description
A skills-training web-app teaching skills for reducing problematic alcohol use.
Intervention Type
Behavioral
Intervention Name(s)
TeleCoach control
Intervention Description
A web-app providing information about the health-related consequences of alcohol consumption.
Primary Outcome Measure Information:
Title
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
Description
Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.
Time Frame
Time between screening measure and 26-week followup
Secondary Outcome Measure Information:
Title
Daily Drinking Questionnaire (DDQ)
Description
The number of standard glasses (12g of ethanol) consumed and over how many hours for each day of a typical week the last month.
Time Frame
Baseline, 6, 12 and 26 week followups.
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
10 questions measuring alcohol consumption and alcohol-related problems.
Time Frame
Baseline and 26-week followup.
Title
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
Description
Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.
Time Frame
Baseline, 6- and 12-week followups.
Title
Readiness Ruler
Description
A visual analogue scale measuring participants' motivation to change their alcohol consumption.
Time Frame
Baseline and 26-week followup.
Title
DSM-5 Alcohol use disorder criteria.
Description
Criteria for the diagnosis Alcohol use disorder in the the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Time Frame
Baseline
Title
Penn Alcohol Craving Scale (PACS)
Description
5 items to measure participants' craving for alcohol.
Time Frame
Baseline, 6, 12 and 26 week followups.
Title
Alcohol Abstinence Self Efficacy scale (AASE)
Description
12 items for measuring self efficacy in the domain of abstaining from drinking alcohol.
Time Frame
Baseline, 6, 12 and 26 week followups.
Title
Drug Use Disorders Identification Test (DUDIT)
Description
11 items for measuring participants' drug consumption and drug-related problems.
Time Frame
Baseline
Title
Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)
Description
9 questions measuring symptoms of depression
Time Frame
Baseline, 6, 12 and 26 week followups.
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
7 questions measuring symptoms of anxiety
Time Frame
Baseline, 6, 12 and 26 week followups.
Title
Treatment questions (7 questions regarding access to other help and support for problematic alcohol use).
Description
7 questions regarding access to other help and support for problematic alcohol use.
Time Frame
Baseline and 26 week followup.
Title
Usability questions regarding the participants' experience of using the web-app they were assigned.
Description
Questions regarding the participants' experience of using the web-app they were assigned.
Time Frame
26 week followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years Risky alcohol consumption defined as Alcohol Use Disorders Identification Test (AUDIT) scores of ≥6 points for women and ≥ 8 points for men. Exclusion Criteria: Severe depression, defined as a MADRS-S score of > 30 Sucide risk, defined as a MADRS-S, item 9 (Lust for life) score > 4 Drug abuse, defined as a score of ≥ 8 on the DUDIT
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:
PubMed Identifier
32536880
Citation
Berman AH, Molander O, Tahir M, Tornblom P, Gajecki M, Sinadinovic K, Andersson C. Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. Front Psychiatry. 2020 May 27;11:434. doi: 10.3389/fpsyt.2020.00434. eCollection 2020.
Results Reference
derived

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Skills-training for Reducing Risky Alcohol Use in App Form

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