Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use

Alcohol Consumption Clinical Trial

Official title:

Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037630
• Other study ID #: ALCOHOLDIARY1
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. Access to internet

3. =8 points for men and =6 points for women on Alcohol Use Disorders Identification Test (AUDIT)

Exclusion Criteria:

1. Insufficient knowledge of the Swedish language

2. Difficulties reading or writing related to a digital intervention.

3. Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).

4. High suicide risk based on telephone assessment.

5. Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Behavioral:
• Self-guided Digital Tool for Problematic Alcohol Use
See arm/group-description

Locations

Country	Name	City	State
Sweden	Centrum för Psykiatriforskning	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behavioral engagement	Number of alcohol diary entries	Immediately after the intervention
Other	Telephone interview on perceptions of intervention	Quotes	Immediately after the intervention
Primary	Standardized drinks per week (based on Time Line Follow Back)	Changes in standardized drinks per week (using Time Line Follow Back)	3 months after intervention
Primary	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)	3 months after intervention
Secondary	Standardized drinks per week (based on Time Line Follow Back)	Changes in standardized drinks per week (using Time Line Follow Back)	Immediately after the intervention
Secondary	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)	Immediately after the intervention
Secondary	Diagnostic criteria Alcohol Use Disorder	Using SCID-5	3 months after intervention
Secondary	Diagnostic criteria Alcohol Use Disorder	Using SCID-5	Immediately after the intervention
Secondary	System Usability Scale	System Usability Scale (SUS), score range 0-100, higher is better.	Immediately after the intervention
Secondary	Credibility/Expectancy questionnaire	Credibility/Expectancy questionnaire, score range 0-50, higher is better	Immediately after the intervention
Secondary	Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	3 months after intervention
Secondary	Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	Immediately after the intervention
Secondary	Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	3 months after intervention
Secondary	Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	Immediately after the intervention
Secondary	Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	3 months after intervention
Secondary	Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	Immediately after the intervention
Secondary	Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	3 months after intervention
Secondary	Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	Immediately after the intervention
Secondary	Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	3 months after intervention
Secondary	Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	Immediately after the intervention