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Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

Primary Purpose

Drinking Excessive

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ALVA
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drinking Excessive

Eligibility Criteria

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

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

  • Centre for Psychiatry ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Digital Tool for Problematic Alcohol Use

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview

Digital Tool for Problematic Alcohol Use + Written Guidance

Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance

Arm Description

This is the base version of the intervention with no added guidance.

This is the same intervention as the base version, with an added mid-treatment telephone interview.

This is the same intervention as the base version, with added weekly written guidance.

This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview.

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)

Secondary Outcome Measures

Standardized drinks per week (based on Time Line Follow Back)
Changes in standardized drinks per week (using Time Line Follow Back)
Diagnostic criteria Alcohol Use Disorder
Using SCID-5, number of diagnostic criteria 0-11, lower 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
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
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
Readiness to change questionnaire
Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase

Full Information

First Posted
December 6, 2022
Last Updated
February 14, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT05649982
Brief Title
Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
Official Title
Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

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 effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a 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. The trial will be a 2*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking Excessive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2*2 factorial experiment
Masking
None (Open Label)
Masking Description
The level of added guidance received will be open to the participants. The main outcome of Alcohol consumption will be self-rated.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Tool for Problematic Alcohol Use
Arm Type
Experimental
Arm Description
This is the base version of the intervention with no added guidance.
Arm Title
Digital Tool for Problematic Alcohol Use + Extra Telephone Interview
Arm Type
Experimental
Arm Description
This is the same intervention as the base version, with an added mid-treatment telephone interview.
Arm Title
Digital Tool for Problematic Alcohol Use + Written Guidance
Arm Type
Experimental
Arm Description
This is the same intervention as the base version, with added weekly written guidance.
Arm Title
Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance
Arm Type
Experimental
Arm Description
This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview.
Intervention Type
Behavioral
Intervention Name(s)
ALVA
Intervention Description
Behavioural digital self-help intervention
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
Immediately after the 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
12 months after intervention
Title
Diagnostic criteria Alcohol Use Disorder
Description
Using SCID-5, number of diagnostic criteria 0-11, lower is better
Time Frame
6 months after intervention
Title
Credibility/Expectancy questionnaire
Description
Credibility/Expectancy questionnaire, score range 0-50, higher is better
Time Frame
Mid-intervention (4 weeks after intervention start)
Title
Alcohol Use Disorders Identification Test
Description
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Time Frame
12 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
12 months after intervention
Title
Penn Alcohol Craving Scale
Description
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Time Frame
12 months after intervention
Title
Patient Health Questionnaire 9
Description
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Time Frame
12 months after intervention
Title
Generalized Anxiety Disorder 7
Description
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Time Frame
12 months after intervention
Title
Readiness to change questionnaire
Description
Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase
Time Frame
12 months after intervention
Other Pre-specified Outcome Measures:
Title
Clinician time
Description
Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Kraepelien, PhD
Phone
+46703017500
Email
martin.kraepelien@ki.se
Facility Information:
Facility Name
Centre for Psychiatry Research
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitya Jayaram-Lindström, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD available anonymized on reasonable request.

Learn more about this trial

Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

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