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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Tool for Problematic Alcohol Use | Experimental | This is the base version of the intervention with no added guidance. |
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| 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. |
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| Digital Tool for Problematic Alcohol Use + Written Guidance | Experimental | This is the same intervention as the base version, with added weekly written guidance. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALVA | Behavioral | Behavioural digital self-help intervention |
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| 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 |
| 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) | 12 months after intervention |
| Diagnostic criteria Alcohol Use Disorder |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician time | Time in minutes the clinician spends on the participant giving guidance through telephone calls and/or written guidance, in minutes, lower is better. | Immediately after the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Kraepelien, PhD | Contact | +46703017500 | martin.kraepelien@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Psychiatry Research | Recruiting | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38383426 | Derived | 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. |
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IPD available anonymized on reasonable request.
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2*2 factorial experiment
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The level of added guidance received will be open to the participants. The main outcome of Alcohol consumption will be self-rated.
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Using SCID-5, number of diagnostic criteria 0-11, lower is better
| 6 months after intervention |
| Credibility/Expectancy questionnaire | Credibility/Expectancy questionnaire, score range 0-50, higher is better | 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 | 12 months after intervention |
| Brunnsviken Brief Quality of Life Scale | Brunnsviken Brief Quality of Life Scale (BBQ), score range 0-96, higher is better | 12 months after intervention |
| Penn Alcohol Craving Scale | Penn Alcohol Craving Scale (PACS), score range 0-30, lower is better | 12 months after intervention |
| Patient Health Questionnaire 9 | Patient Health Questionnaire 9 (PHQ-9), score range 0-27, lower is better | 12 months after intervention |
| Generalized Anxiety Disorder 7 | Generalized Anxiety Disorder 7 (GAD-7), score range 0-21, lower is better | 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 | 12 months after intervention |