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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Behavioral: Self-guided Digital Tool for Problematic Alcohol Use

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Centrum för Psykiatriforskning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-guided Digital Tool for Problematic Alcohol Use; Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention.	Behavioral: Self-guided Digital Tool for Problematic Alcohol Use; See arm/group-description; Other Names: ALVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Diagnostic criteria Alcohol Use Disorder	Using SCID-5	3 months after intervention
Diagnostic criteria Alcohol Use Disorder	Using SCID-5	Immediately after the intervention
System Usability Scale	System Usability Scale (SUS), score range 0-100, higher is better.	Immediately after the intervention
Credibility/Expectancy questionnaire	Credibility/Expectancy questionnaire, score range 0-50, higher is better	Immediately after the intervention
Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	3 months after intervention
Alcohol Use Disorders Identification Test	Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better	Immediately after the intervention
Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	3 months after intervention
Brunnsviken Brief Quality of Life Scale	Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better	Immediately after the intervention
Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	3 months after intervention
Penn Alcohol Craving Scale	Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better	Immediately after the intervention
Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	3 months after intervention
Patient Health Questionnaire 9	Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better	Immediately after the intervention
Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	3 months after intervention
Generalized Anxiety Disorder 7	Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better	Immediately after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral engagement	Number of alcohol diary entries	Immediately after the intervention
Telephone interview on perceptions of intervention	Quotes	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: ALCOHOLDIARY1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No