Alcohol ConsumptionNCT05037630
Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
A study testing Self-guided Digital Tool for Problematic Alcohol Use in people with Alcohol Consumption, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Self-guided Digital Tool for Problematic Alcohol Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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.
- Conditions
- Alcohol Consumption
- Being tested
- Self-guided Digital Tool for Problematic Alcohol Use
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided Digital Tool for Problematic Alcohol UseBehavioural
Also called ALVA
See arm/group-description
| Study group | Role | What they receive |
|---|---|---|
| Self-guided Digital Tool for Problematic Alcohol Use | Experimental | Self-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention. Receives: Behavioral: Self-guided Digital Tool for Problematic Alcohol Use |
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: 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)
Measured: 3 months after intervention
Secondary outcomes (16)
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
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)
Measured: Immediately after the intervention
Diagnostic criteria Alcohol Use Disorder
Using SCID-5
Measured: 3 months after intervention
Diagnostic criteria Alcohol Use Disorder
Using SCID-5
Measured: Immediately after the intervention
System Usability Scale
System Usability Scale (SUS), score range 0-100, higher is better.
Measured: Immediately after the intervention
Credibility/Expectancy questionnaire
Credibility/Expectancy questionnaire, score range 0-50, higher is better
Measured: Immediately after the intervention
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Measured: 3 months after intervention
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test (AUDIT), score range 0-40, lower is better
Measured: Immediately after the intervention
Brunnsviken Brief Quality of Life Scale
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Measured: 3 months after intervention
Brunnsviken Brief Quality of Life Scale
Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better
Measured: Immediately after the intervention
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Measured: 3 months after intervention
Penn Alcohol Craving Scale
Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better
Measured: Immediately after the intervention
Patient Health Questionnaire 9
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Measured: 3 months after intervention
Patient Health Questionnaire 9
Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better
Measured: Immediately after the intervention
Generalized Anxiety Disorder 7
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Measured: 3 months after intervention
Generalized Anxiety Disorder 7
Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start27 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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 Alcohol ConsumptionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT05037630
- Sponsor's protocol ID
- ALCOHOLDIARY1
- Status last verified
- May 2022
- First submitted
- 27 Aug 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraepelien M, Sundstrom C, Johansson M, Ivanova E. Digital psychological self-care for problematic alcohol use: feasibility of a new clinical concept. BJPsych Open. 2023 May 24;9(3):e91. doi: 10.1192/bjo.2023.73.
PubMed 37222099
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of a Self-guided Digital Tool for Problematic Alcohol Use
- ClinicalTrials.gov ID
- NCT05037630
- Acronym / sponsor ID
- ALCOHOLDIARY1
- Conditions
- Alcohol Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Sep 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-guided Digital Tool for Problematic Alcohol Use | Experimental | Behavioral: Self-guided Digital Tool for Problematic Alcohol UseSelf-guided Digital Tool for Problematic Alcohol Use during 8 weeks with clinical telephone interviews pre ant post intervention. |
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 |
|---|---|---|
| Self-guided Digital Tool for Problematic Alcohol UseAlso: ALVASee arm/group-description | Behavioural | Self-guided Digital Tool for Problematic Alcohol Use |
Primary outcome
Standardized drinks per week (based on Time Line Follow Back)
Time frame: 3 months after intervention
Changes in standardized drinks per week (using Time Line Follow Back)
Heavy drinking days (based on Time Line Follow Back)
Time frame: 3 months after intervention
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)
16 secondary outcomes
Standardized drinks per week (based on Time Line Follow Back)
Time frame: Immediately after the intervention
Heavy drinking days (based on Time Line Follow Back)
Time frame: Immediately after the intervention
Diagnostic criteria Alcohol Use Disorder
Time frame: 3 months after intervention
Diagnostic criteria Alcohol Use Disorder
Time frame: Immediately after the intervention
System Usability Scale
Time frame: Immediately after the intervention
Credibility/Expectancy questionnaire
Time frame: Immediately after the intervention
Alcohol Use Disorders Identification Test
Time frame: 3 months after intervention
Alcohol Use Disorders Identification Test
Time frame: Immediately after the intervention
Brunnsviken Brief Quality of Life Scale
Time frame: 3 months after intervention
Brunnsviken Brief Quality of Life Scale
Time frame: Immediately after the intervention
Penn Alcohol Craving Scale
Time frame: 3 months after intervention
Penn Alcohol Craving Scale
Time frame: Immediately after the intervention
Patient Health Questionnaire 9
Time frame: 3 months after intervention
Patient Health Questionnaire 9
Time frame: Immediately after the intervention
Generalized Anxiety Disorder 7
Time frame: 3 months after intervention
Generalized Anxiety Disorder 7
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 37222099Kraepelien M, Sundstrom C, Johansson M, Ivanova E. Digital psychological self-care for problematic alcohol use: feasibility of a new clinical concept. BJPsych Open. 2023 May 24;9(3):e91. doi: 10.1192/bjo.2023.73.
- Individual participant dataSharing planned: No
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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 Self-guided Digital Tool for Problematic Alcohol Use in people with Alcohol Consumption, 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: finished, as of the sponsor's last update on 23 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 months after intervention). The study lists 2 primary outcomes in all. 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 NCT05037630, 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 23 May 2022.