Trial document




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  DRKS00027323

Trial Description

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Title

Investigation of acute effects of controlled slow breathing in the morning and in the evening as an add-on therapy for patients with somatoform disorder / somatic stress disorder

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Trial Acronym

ATEM-SOMA

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URL of the Trial

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Brief Summary in Lay Language

Slow breathing is a breathing technique that aims to consciously and deliberately slow down the inhalation and exhalation phases. This is usually done with the guidance of a visual, auditory, or kinesthetic breath pacemaker. Some systematic reviews have already shown positive effects of a reduced respiratory rate on physiological and psychological parameters.

Studies also indicate that the use of this breathing technique generates added value as a supplement to conventional treatment interventions for people with symptoms of depression and anxiety.

Often patients with a somatoform disorder / somatic stress disorder often suffer from other psychiatric illnesses such as an anxiety disorder or depression. The treatment of these patients is multimodal and often lengthy and difficult, especially in the case of complex and chronically ill patients.

With the present exploratory, clinical pilot study, the acute effects of a week-long breathing training, in which the breathing rate is deliberately slowed down, are to be examined for the first time in patients with somatoform disorders and depressive patients with somatic syndrome in the inpatient treatment context. The study will include patients from the psychosomatic medicine ward, University Clinic for Psychiatry II (Innsbruck).

The training should be based on the personal resonant breathing rate (= the breathing rate that results in increased heart rate variability in the person) and should be carried out twice a day (in the morning after getting up and in the evening before going to bed) over a period of one week .

The verum intervention includes reduced breathing using a visual breath pacemaker. This visual pacemaker, generated by a room lamp, utilizes dynamic bright, daylight-like white light in the morning and dimmed warm white light in the evening. In a control condition, the same patients should only be exposed to standard room lighting at the same time of the day (in randomized order either one week before or one week later).

The present study implements a randomized, controlled two-arm study design with repeated measurements.

Measured variables of the present study are the subjectively experienced physical well-being, the quality of sleep and the physical and cognitive arousal before going to bed, which are evaluated by the patient immediately after breathing training. Furthermore, immediate physiological effects during breathing training should be measured through
heart rate variability measures. Finally, possible side effects and satisfaction with the intervention should be queried.

The aim of this pilot study is to determine whether and to what extent such breathing training is accepted by patients as an additional treatment option in the course of inpatient treatment. Moreover, first acute psychophysiological effects are documented.

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Brief Summary in Scientific Language

Slow breathing is a breathing technique that aims to consciously and deliberately slow down the inhalation and exhalation phases. This is usually done with the guidance of a visual, auditory, or kinesthetic breath pacemaker.

Studies have shown (see review by Lehrer et al. 2020) that a deliberate slowing down of the breathing rate leads to a reduction in the efferent branch of the vagus nerve. A reduction in the breathing rate (up to 6 breaths per minute) further increases the respiratory sinus arrhythmia and the baroreflex function and thus has a significant influence on the activity of the autonomic nervous system.

Some systematic reviews have already shown positive effects of a reduced respiratory rate on physiological and psychological parameters. For example, Pizzoli and colleagues (2021) showed that slow breathing can reduce depressive symptoms with a medium effect size (g = 0.38) . Furthermore, Leyro and colleagues (2021) demonstrated medium to large effects of slowed breathing on the reduction of anxiety symptoms. Both reviews indicate that the use of this breathing technique as a supplement to other treatment interventions make cause additional beneficial effects for people with symptoms of depression and anxiety.

Patients with a somatoform disorder / somatic stress disorder report body-related complaints that cannot be adequately explained somatically. In principle, these complaints can affect many organ systems and differ greatly on the somatic level.
Often, a somatoform disorder coexists with other psychiatric illnesses such as an anxiety disorder or depression. The therapy of “functional physical complaints” is multimodal and geared towards the individual needs of the patient and usually consists of pharmacotherapy, psychotherapy, physical therapy, and learning relaxation techniques. Nevertheless, the treatments are often protracted and difficult, especially in the case of complex and chronically ill patients.

A somatic syndrome can occur in addition to the main symptoms of a depressive episode or recurrent depressive disorder. For these patients, too, multimodal treatments are used today, similar to those for patients with a somatoform disorder, in an inpatient context.

With the present exploratory, clinical pilot study, acute effects of a week-long breathing training, in which the breathing rate is deliberately slowed down, are to be examined for the first time in patients with somatoform disorders and depressive patients with somatic syndrome in the inpatient treatment context.

The training should be based on the personal resonant breathing rate (= the breathing rate that results in increased heart rate variability in the person) and should be carried out twice a day (in the morning after getting up and in the evening before going to bed) over a period of one week .

Furthermore, the present pilot study is intended to determine whether and to what extent such breathing training is accepted by patients as an additional treatment offer in the course of inpatient treatment.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The pseudonymized raw data from the questionnaires and derived heart rate variability parameters can be made available to other researchers on the basis of a reasonable request.

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Organizational Data

  •   DRKS00027323
  •   2021/11/30
  •   2021/11/18
  •   yes
  •   Approved
  •   1375/2021, Ethikkommission der Medizinischen Universität Innsbruck
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Secondary IDs

  •   U1111-1271-9863 
  •   1375/2021  (https://ek-mui-tirol.at/)
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Health Condition or Problem studied

  •   F45 -  Somatoform disorders
  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   Morning breathing training (Monday to Friday between 6 a.m. and 7 a.m.):
    15 minutes of breathing training based on the personal resonant breathing frequency with the help of dynamic room brightness as an optical breath pacer (0 lux to 5000 lux with neutral white light color, 5300 Kelvin)

    Evening breathing training (from Monday to Friday between 9 p.m. and 10 p.m.):
    15 minutes of breathing training based on the personal resonant breathing frequency with the help of dynamic room brightness as an optical breath pacer (0 lux to 20 lux with warm white light color, 2200 Kelvin)
  •   Morning breathing training (Monday to Friday between 6 a.m. and 7 a.m.):
    15 minutes of room light exposure under constant standard office lighting conditions according to DIN EN 12464-1 (100 lux with neutral white light color, 5300 Kelvin)

    Evening breathing training (from Monday to Friday between 9 p.m. and 10 p.m.):
    15 minutes of room light exposure in a standard room lighting condiiton for a private living environment (20 lux with warm white light color, 2200 Kelvin)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Placebo
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

(1) The morning breathing training increases physical well-being (measured with 2 scales of the questionnaire on current well-being) both when training for the first time (on Monday) and on the 5th training day (on Friday of the same week) compared to the control intervention.

(2) The evening breathing training reduces the cognitive and somatic arousal immediately before going to bed (measured with the Presleep-Arousal Scale) both when training for the first time (on Monday) and on the 5th training day (on Friday of the same week) compared to the control intervention.

(3) The morning breathing training shows no side effects after the 5th training days (on Friday morning) (measured by self-assessment using 13 items).

(4) The evening breathing training showed no side effects after the 5th training days (on Friday evening) (measured by self-assessment using 13 items).

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Secondary Outcome

(1) The breathing training improves sleep quality (measured with the Insomia Severity Index, ISI) on the 5th training day compared to the control intervention.

(2) The breathing training improves the self-assessed symptoms of depression, anxiety and somatization (measured with the Brief Symptom Scale, BSI-18) on the 5th training day compared to the control intervention.

(3) Morning respiratory training increases the activity of the sympathetic nervous system and reduces the activity of the parasympathetic nervous system (measured with the heart rate variability parameters heart rate, pNN50, RMSSD, SDNN, SD1, SD2, high
frequency%, low frequency%, low frequency: high frequency) both when training for the first time on Monday morning and on the 5th training day (Friday morning) compared to the control intervention.

(4) The evening breathing training reduces the activity of the sympathetic nervous system and increases the activity of the parasympathetic nervous system (measured with the heart rate variability parameters heart rate, pNN50, RMSSD, SDNN, SD1, SD2, high frequency%, low frequency%, low frequency: high frequency) both when training for the first time on Monday evening and on the 5th training day (Friday evening) compared to the control intervention.

(5) The patients are more satisfied with the morning breathing training on the 5th training day (Friday morning) (measured using self-assessment, 2 items) than with the morning control condition.

(6) The patients are more satisfied with the evening breathing training on the 5th training day (Friday evening) (measured using self-disclosure, 2 items) than with the evening control condition.

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2022/01/10
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- One of the following ICD-10 diagnoses is present: F32.01, F32.11, F33.01, F33.11, F43.2 or F45.0 to F45.9 (psychological comorbidities are allowed)
- between 18-70 years of age
- Very good language skills in: German, Turkish or Serbo-Croatian

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Exclusion Criteria

- the presence of dementia
- acute suicidality
- acute, untreated psychotic symptoms
- the presence of an acute infectious or other internal illness which interferes with the performance of breathing exercises
- if the inpatient treatment is discontinued

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Addresses

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    • Medizinische Universität Innsbruck
    • Ms.  Assoc.Prof. Priv.-Doz. Dr.  Katharina  Hüfner 
    • Christoph-Probst-Platz 1, Innrain 52 A, Fritz-Pregl-Straße 3
    • 6020  Innsbruck
    • Austria
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    • Universität Innsbruck
    • Mr.  Ass.-Prof. DI MMag. MSc. PhD.  Markus  Canazei 
    • Innrain 52f
    • 6020  Innsbruck
    • Austria
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    • Universität Innsbruck
    • Mr.  Ass.-Prof. DI MMag. MSc. PhD.  Markus  Canazei 
    • Innrain 52f
    • 6020  Innsbruck
    • Austria
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Sources of Monetary or Material Support

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    • Universität Innsbruck
    • Mr.  Ass.-Prof. DI MMag. MSc. PhD.  Markus  Canazei 
    • Innrain 52f
    • 6020  Innsbruck
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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