Development of an individualized Circadian Daily Structure Therapy for Patients with Alcohol dependence and comorbid depressio

Phase 1

• Conditions: F10.2; F32.0; F32.1; F32.2; F32.8; F32.9; Mild depressive episode; Moderate depressive episode; Severe depressive episode without psychotic symptoms; Other depressive episodes

• Registration Number: DRKS00019093
• Lead Sponsor: Klinik der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-28
• Study Completion: 2024-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

All persons on whom the below exclusion criteria do not apply. Special attention is paid to the assessment of the test persons' ability to understand the scope of the study. Subjects are only included in the study if they can assess the nature and scope of the investigations. Written consent is required for inclusion. The study is conducted in accordance with the principles of the Declaration of Helsinki with its amendments of Tokyo, 1975, Hong Kong, 1989, Somerset West, 1996, Seoul, 2008 and Fortaleza, 2013. The subjects must suffer from alcohol dependence and depression. The MDD diagnosis must meet the following criteria for our study: Only unipolar depression, only recurrent depression with at least mild depression. Currently, there should be no psychotic symptoms or acute suicidal tendencies.

Exclusion Criteria

Inability to give consent, pregnancy, current shift work, intellectual, neurological or physical impairment, other psychiatric illness (except alcohol addiction and MDD), other substance addictions (except alcohol), blindness, dependence on help with eating or going to bed (e.g. like bedridden patients).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary variable surveyed is the relapse rate for alcohol addiction in the first four weeks after discharge from withdrawal.<br><br>It is measured at the beginning and the end of the study by questionnaires (AUDIT, EuropASI), blood values (GOT, GPT, ?-GT, MCV, MCH, CDT) and retrograde self-disclosure of the subjects (Alcohol Timeline Followback 30). In addition, the participants enter possible relapses in a diary.

Secondary Outcome Measures

Name	Time	Method
Secondary variables are depressive mood, sleep quality, chronotype, self-efficacy, and general physical well-being of the subjects in the first four weeks after withdrawal.<br><br>The secondary target criteria are measured at the beginning and the end of the study as follows:<br><br>Depressive mood - Hamilton Depression Scale (HAM-D), inventory of depressive symptoms (IDS-SR),<br><br>Sleep Quality - Pittsburgh Sleep Quality Index (PSQI),<br><br>Chronotype - Munich Chronotype Questionnaire (MCTQ),<br><br>Self-efficacy - General expectation of self-efficacy (SWE),<br><br>Physical well-being - Health status questionnaire (SF-36).