Drinking ExcessiveNCT05649982
Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
A study testing ALVA in people with Drinking Excessive, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drinking Excessive
- What is being tested?
- ALVA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Access to internet
- ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Drinking Excessive
- Being tested
- ALVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVABehavioural
Behavioural digital self-help intervention
| Study group | Role | What they receive |
|---|---|---|
| Digital Tool for Problematic Alcohol Use | Experimental | This is the base version of the intervention with no added guidance. Receives: Behavioral: ALVA |
| Digital Tool for Problematic Alcohol Use + Extra Telephone Interview | Experimental | This is the same intervention as the base version, with an added mid-treatment telephone interview. Receives: Behavioral: ALVA |
| Digital Tool for Problematic Alcohol Use + Written Guidance | Experimental | This is the same intervention as the base version, with added weekly written guidance. Receives: Behavioral: ALVA |
| Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance | Experimental | This is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview. Receives: Behavioral: ALVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized drinks per week (based on Time Line Follow Back)
Changes in standardized drinks per week (using Time Line Follow Back)
Measured: Immediately after the intervention
Secondary outcomes (9)
Standardized drinks per week (based on Time Line Follow Back)
Changes in standardized drinks per week (using Time Line Follow Back)
Measured: 12 months after intervention
Diagnostic criteria Alcohol Use Disorder
Using SCID-5, number of diagnostic criteria 0-11, lower is better
Measured: 6 months after intervention
Credibility/Expectancy questionnaire
Credibility/Expectancy questionnaire, score range 0-50, higher is better
Measured: Mid-intervention (4 weeks after intervention start)
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Measured: 12 months after intervention
Brunnsviken Brief Quality of Life Scale
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Measured: 12 months after intervention
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Measured: 12 months after intervention
Patient Health Questionnaire 9
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Measured: 12 months after intervention
Generalized Anxiety Disorder 7
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Measured: 12 months after intervention
Readiness to change questionnaire
Readiness to change questionnaire (RCQ), determines if the participant are in a precontemplation phase, contemplation phase or action phase
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start11 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drinking ExcessiveStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2\*2 factorial experiment
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649982
- Sponsor's protocol ID
- ALCOHOLDIARY2
- Status last verified
- Aug 2026
- First submitted
- 6 Dec 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD available anonymized on reasonable request.
Publications
Sundstrom C, Ivanova E, Lindner P, Johansson M, Kraepelien M. Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)-protocol for a randomized factorial optimization trial. Trials. 2024 Feb 21;25(1):136. doi: 10.1186/s13063-024-07981-6.
PubMed 38383426
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
- ClinicalTrials.gov ID
- NCT05649982
- Acronym / sponsor ID
- ALCOHOLDIARY2
- Conditions
- Drinking Excessive
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2*2 factorial experiment
| Arm | Type | Receives |
|---|---|---|
| Digital Tool for Problematic Alcohol Use | Experimental | Behavioral: ALVAThis is the base version of the intervention with no added guidance. |
| Digital Tool for Problematic Alcohol Use + Extra Telephone Interview | Experimental | Behavioral: ALVAThis is the same intervention as the base version, with an added mid-treatment telephone interview. |
| Digital Tool for Problematic Alcohol Use + Written Guidance | Experimental | Behavioral: ALVAThis is the same intervention as the base version, with added weekly written guidance. |
| Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance | Experimental | Behavioral: ALVAThis is the same intervention as the base version, with added weekly written guidance and an added mid-treatment telephone interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Access to internet
- ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALVABehavioural digital self-help intervention | Behavioural | Digital Tool for Problematic Alcohol Use, Digital Tool for Problematic Alcohol Use + Extra Telephone Interview, Digital Tool for Problematic Alcohol Use + Extra Telephone Interview and Written Guidance, Digital Tool for Problematic Alcohol Use + Written Guidance |
Primary outcome
Standardized drinks per week (based on Time Line Follow Back)
Time frame: Immediately after the intervention
Changes in standardized drinks per week (using Time Line Follow Back)
9 secondary outcomes
Standardized drinks per week (based on Time Line Follow Back)
Time frame: 12 months after intervention
Diagnostic criteria Alcohol Use Disorder
Time frame: 6 months after intervention
Credibility/Expectancy questionnaire
Time frame: Mid-intervention (4 weeks after intervention start)
Alcohol Use Disorders Identification Test
Time frame: 12 months after intervention
Brunnsviken Brief Quality of Life Scale
Time frame: 12 months after intervention
Penn Alcohol Craving Scale
Time frame: 12 months after intervention
Patient Health Questionnaire 9
Time frame: 12 months after intervention
Generalized Anxiety Disorder 7
Time frame: 12 months after intervention
Readiness to change questionnaire
Time frame: 12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 38383426Sundstrom C, Ivanova E, Lindner P, Johansson M, Kraepelien M. Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)-protocol for a randomized factorial optimization trial. Trials. 2024 Feb 21;25(1):136. doi: 10.1186/s13063-024-07981-6.
- Individual participant dataSharing planned: Undecided. IPD available anonymized on reasonable request.
Related trials for Drinking Excessive
Active, not recruiting
Barbershop Talk: Reducing Excessive Alcohol Consumption Among Men
Drinking Behavior, Drinking Excessive
Not yet recruiting
Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care
Substance Use, Binge Drinking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALVA in people with Drinking Excessive, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized drinks per week (based on Time Line Follow Back) (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.