Trial document




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  DRKS00019093

Trial Description

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Title

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

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Trial Acronym

DAILY

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URL of the Trial

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Brief Summary in Lay Language

Circadian clocks (~ 24 hours) have evolved in the course of evolution in almost all living beings, including humans, to adjust the organism to recurring daily events. Almost all processes and functions of our body are controlled by an internal clock, the so-called circadian clock. It has already been shown that virtually all higher brain functions are controlled by circadian rhythms.
As a result, disturbed circadian clocks have been shown to contribute to the development of mood disorders, including major depressive disorder (MDD), and addictive disorders such as alcohol dependence. Alcohol dependence has a high co-morbidity with depressive disorders. In patients with alcohol dependence, co-morbidity with depressive disorders is between 30% and 60%. Since the circadian system controls important brain systems, including areas associated with the regulation of reward sensations as well as affective states, we suspect that circadian clock disorder plays a central role in the co-morbidity of alcohol dependence and depression. In addition, addiction patients often report a lack of daily structures and irregularities in the daily routine. Based on described data, the aim of this pilot study is to investigate the circadian profile of patients with alcohol dependence and depression and to develop a personalized therapy that stabilizes the circadian rhythms of the patients during alcohol withdrawal and the first phase of abstinence in order to better prevent relapses and positively influence the mood of the patients. To achieve this goal, circadian variables such as sleep time preferences (chronotype), daily sleep/wake rhythms, resting/activity patterns, and meal times will be determined using questionnaires and diaries. Adapted to individual time of day preferences, a daily structure plan is then drawn up, which patients should strictly follow during and after withdrawal. We expect that patients receiving this additional circadian therapy will be less likely to relapse and suffer less from depressive moods than control patients receiving placebo treatment. Furthermore, at the beginning and end of the study, blood parameters will be measured that are usually altered in alcohol-dependent patients. Since circadian rhythms regulate the processes of virtually all physical processes, we assume that physiological impairments will improve. With this pilot study, we want to test whether the regeneration of circadian rhythms contributes to a more successful treatment of alcohol dependence, depressive disorders and physical impairments, in order to develop a comprehensive therapy program in the future, which can then be tested on a larger group of patients at different sites.

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Brief Summary in Scientific Language

The circadian system of the body is hierarchically structured. The suprachiasmatic nucleus (SCN) in the hypothalamus is the main pacemaker of all other cellular clocks in other brain regions and peripheral tissues. The circadian clock in the SCN and in other tissues is brought into synchrony with the daily rhythms of the environment by so-called Zeitgebers (German: time givers) such as light, food, physical activity and temperature. A disturbance of circadian clocks can cause far-reaching health problems. The loss of temporal synchronisation of biological processes plays a major role here. Circadian clock genes, which are rhythmically expressed within 24 hours, serve as transcription factors and thus transfer their own rhythmicity to about half of all our genes. As a result, virtually all physiological processes are under the control of the circadian system and change their activity during the day. Thus, for example, there is a temporal separation of anabolic and catabolic processes, the sequence of complex processes that build on or depend on each other is synchronized, and the communication of brain areas is synchronized. It is therefore not surprising that a disturbance of the clock, for example due to genetic disposition or external factors such as shift work or irregular lifestyles, has been associated with an increased risk of many disorders. In these people, the circadian system is permanently in a transient state and cannot adapt to a certain course of events, which can lead to physiological and psychological disorders. Shift workers, for example, suffer more from depression and increased alcohol consumption. Conversely, many depressed and alcohol-dependent patients show a disturbance of their daily rhythms, which is often reflected on their behavioural level in the form of unstructured daily routines. Within the framework of this study, a therapy (psycho education, short-term intervention) was developed in which a personalised daily structure with fixed repetitive processes is designed together with patients with alcohol dependence and comorbid depression. This daily schedule is used primarily during the first four weeks after discharge from the detoxification facility. Strict adherence to daily routines (bed times, meal times, etc.) is intended on the one hand to provide psychological support for patients and on the other hand to strengthen their circadian system by regular exposure of Zeitgebers. It is expected that the strengthening of circadian clocks will reduce both the relapse rate and the depressive symptoms of patients by optimising physiological processes and improving the coordination of higher brain functions.

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Forwarding of patient-related data:

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019093
  •   2019/11/28
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  •   yes
  •   Approved
  •   19-636, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
  •   F10.3 -  Mental and behavioural disorders due to use of alcohol; Withdrawal state
  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F32.8 -  Other depressive episodes
  •   F32.9 -  Depressive episode, unspecified
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Interventions/Observational Groups

  •   Intervention group: psychoeducation, one-hour intervention, plus diary for day structuring over 6 weeks (DAILY program)
  •   Control group: One-hour sham condition (discussion on socially relevant addiction topics), plus diary for day structuring over 6 weeks (control program)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

The primary endpoint is the relapse rate of alcohol addiction in the first four weeks after withdrawal.

It is measured by questionnaires (AUDIT, EuropASI), blood values (GOT, GPT, γ-GT, MCV, MCH, CDT) and retrograde self-disclosure of the subjects (Alcohol Timeline Followback 30).

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Secondary Outcome

Secondary endpoints 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 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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/12/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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.

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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).

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Addresses

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Sources of Monetary or Material Support

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    • Das Klinikum der Universität München
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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