Back to resultsFeasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Self-guided Digital Tool for Problematic Alcohol Use
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Consumption
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- Access to internet
- ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)
Exclusion Criteria:
- Insufficient knowledge of the Swedish language
- Difficulties reading or writing related to a digital intervention.
- Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).
- High suicide risk based on telephone assessment.
- Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.
Sites / Locations
- Centrum för Psykiatriforskning
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-guided Digital Tool for Problematic Alcohol Use
Arm Description
Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention.
Outcomes
Primary Outcome Measures
Standardized drinks per week (based on Time Line Follow Back)
Changes in standardized drinks per week (using Time Line Follow Back)
Heavy drinking days (based on Time Line Follow Back)
Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back)
Secondary Outcome Measures
Standardized drinks per week (based on Time Line Follow Back)
Changes in standardized drinks per week (using Time Line Follow Back)
Heavy drinking days (based on Time Line Follow Back)
Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back)
Diagnostic criteria Alcohol Use Disorder
Using SCID-5
Diagnostic criteria Alcohol Use Disorder
Using SCID-5
System Usability Scale
System Usability Scale (SUS), score range 0-100, higher is better.
Credibility/Expectancy questionnaire
Credibility/Expectancy questionnaire, score range 0-50, higher is better
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Brunnsviken Brief Quality of Life Scale
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Brunnsviken Brief Quality of Life Scale
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Patient Health Questionnaire 9
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Patient Health Questionnaire 9
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Generalized Anxiety Disorder 7
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Generalized Anxiety Disorder 7
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Full Information
NCT ID
NCT05037630
First Posted
August 27, 2021
Last Updated
May 20, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT05037630
Brief Title
Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Official Title
Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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
The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. An uncontrolled trial will explore participant's usability and treatment credibility ratings, behavioural engagement and preliminary effects on alcohol use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-guided Digital Tool for Problematic Alcohol Use
Arm Type
Experimental
Arm Description
Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention.
Intervention Type
Behavioral
Intervention Name(s)
Self-guided Digital Tool for Problematic Alcohol Use
Other Intervention Name(s)
ALVA
Intervention Description
See arm/group-description
Primary Outcome Measure Information:
Title
Standardized drinks per week (based on Time Line Follow Back)
Description
Changes in standardized drinks per week (using Time Line Follow Back)
Time Frame
3 months after intervention
Title
Heavy drinking days (based on Time Line Follow Back)
Description
Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back)
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Standardized drinks per week (based on Time Line Follow Back)
Description
Changes in standardized drinks per week (using Time Line Follow Back)
Time Frame
Immediately after the intervention
Title
Heavy drinking days (based on Time Line Follow Back)
Description
Changes in number of heavy drinking days (defined as ≥ 5 (men) or ≥ 4 (women) standardized drinks on a single day, using the Time Line Follow Back)
Time Frame
Immediately after the intervention
Title
Diagnostic criteria Alcohol Use Disorder
Description
Using SCID-5
Time Frame
3 months after intervention
Title
Diagnostic criteria Alcohol Use Disorder
Description
Using SCID-5
Time Frame
Immediately after the intervention
Title
System Usability Scale
Description
System Usability Scale (SUS), score range 0-100, higher is better.
Time Frame
Immediately after the intervention
Title
Credibility/Expectancy questionnaire
Description
Credibility/Expectancy questionnaire, score range 0-50, higher is better
Time Frame
Immediately after the intervention
Title
Alcohol Use Disorders Identification Test
Description
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Time Frame
3 months after intervention
Title
Alcohol Use Disorders Identification Test
Description
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Time Frame
Immediately after the intervention
Title
Brunnsviken Brief Quality of Life Scale
Description
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Time Frame
3 months after intervention
Title
Brunnsviken Brief Quality of Life Scale
Description
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Time Frame
Immediately after the intervention
Title
Penn Alcohol Craving Scale
Description
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Time Frame
3 months after intervention
Title
Penn Alcohol Craving Scale
Description
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Time Frame
Immediately after the intervention
Title
Patient Health Questionnaire 9
Description
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Time Frame
3 months after intervention
Title
Patient Health Questionnaire 9
Description
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Time Frame
Immediately after the intervention
Title
Generalized Anxiety Disorder 7
Description
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Time Frame
3 months after intervention
Title
Generalized Anxiety Disorder 7
Description
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Time Frame
Immediately after the intervention
Other Pre-specified Outcome Measures:
Title
Behavioral engagement
Description
Number of alcohol diary entries
Time Frame
Immediately after the intervention
Title
Telephone interview on perceptions of intervention
Description
Quotes
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age
Access to internet
≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)
Exclusion Criteria:
Insufficient knowledge of the Swedish language
Difficulties reading or writing related to a digital intervention.
Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).
High suicide risk based on telephone assessment.
Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.
Facility Information:
Facility Name
Centrum för Psykiatriforskning
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
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