Optimization of Guidance in a Digital Tool for Problematic Alcohol Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALVA.
- Who it may be relevant to
- Registry conditions: Drinking Excessive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral ALVA
Behavioural digital self-help intervention
Primary outcome measures
- Standardized drinks per week (based on Time Line Follow Back) [Time frame: Immediately after the intervention]
Secondary outcome measures (9)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Centre for Psychiatry Research — Stockholm
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. PMID 38383426
Identifiers
NCT: NCT05649982 · ALCOHOLDIARY2