Individually tailored E-health interventions for primary care patients with problematic alcohol use and co-occurring depressive symptoms: Phase IIa - proof of concept study

Phase 2

• Conditions: At-risk alcohol consumption (average daily intake of alcohol > 12g for women / >24gmen or >= one occasion a month with >= 4 alcoholic drinks for women / >= 5 drinks for men).At-risk alcohol consumption is considered as a risk factor for Harmful Alcohol use (ICD-10F10.1), Alcohol Dependence Syndrome (ICD-10 F10.2), and other alcohol attributable disease.subsyndromal depressive symptoms, majordepression (ICD-10 F32) or dysthymia (ICD-10 F34.1)F10.1: Harmful use of alcoholF10.2: Alcohol dependence syndrom; F10.1; F10.2; F32; F34.1; Depressive episode; Dysthymia

• Registration Number: DRKS00011635
• Lead Sponsor: niversitätsmedizin Greifswald, Institut für Sozialmedizin und Prävention

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-20
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

1) At-risk alcohol consumption (average daily alcohol use of >12g women / 24g men or >= one
occasion a month with >= 4 alcoholic drinks for women / >= 5 drinks for men)
2) subsyndromal depressive symptoms, major depression or dysthymia in the past 12 months.

Exclusion Criteria

1. Severe episode of major depression within the past 12 month and depressive symptoms in the
past 2 weeks;
2. Moderate/severe alcohol use disorder according to DSM-5;
3. Illiteracy, cognitive impairment;
4. Acute or severe illness, which did not allow participation in the study;
5. less than weekly use of the Internet and no accessibility by cell phone.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A sensitive surrogate marker related to drinking behavior<br>change will be analyzed to test potential intervention efficacy.<br>The marker will be a latent composite measure including 1)<br>Frequency of heavy alcohol drinking days, 2) average alcohol intake on drinking days, 3) frequency of drinking days, 4)<br>Intention to change drinking behavior

Secondary Outcome Measures

Name	Time	Method
1) Occurrence of depressive episodes, <br>2) Severity of depressiveness in the worst episode, <br>3) depressiveness at time of follow-up assessment, <br>4) frequency of use of depression preventive strategies