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

Development of an individualized Circadian Daily Structure Therapy for Patients with Alcohol dependence and comorbid depression - DAILY

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00019093
Enrollment
40
Registered
2019-11-28
Start date
2019-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F10.2 F32.0 F32.1 F32.2 F32.8 F32.9

Interventions

Group 1: Intervention group: psychoeducation, one-hour intervention, plus diary for day structuring over 6 weeks (DAILY program) Group 2: Control group: sham-psychoeducation, one-hour sham condition,

Sponsors

Klinik der Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
The primary variable surveyed is the relapse rate for alcohol addiction in the first four weeks after discharge from withdrawal. 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

MeasureTime frame
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. The secondary target criteria are measured at the beginning and the end of the study as follows: Depressive mood - Hamilton Depression Scale (HAM-D), inventory of depressive symptoms (IDS-SR), Sleep Quality - Pittsburgh Sleep Quality Index (PSQI), Chronotype - Munich Chronotype Questionnaire (MCTQ), Self-efficacy - General expectation of self-efficacy (SWE), Physical well-being - Health status questionnaire (SF-36).

Countries

Germany

Contacts

Public ContactDominic Landgraf

AG Circadiane Biologie, Klinik für Psychiatrie und Psychotherapie der Universität München

daily@med.uni-muenchen.de089 4400-55767

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 16, 2026