Deep Diaphragmatic Breathing: Neurobiological and Anti-inflammatory Effects
Condition: Unrecognized Condition
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The exposure to acute and\or chronic stress can produce an activation of sympathetic nervous
      system (SNS), leading to an increased level of cortisol and pro-inflammatory cytokines. The
      mind-body techniques (MBT), such as diaphragmatic breathing, mindfulness, and Yoga, have
      demonstrated their validity in reducing mental stress and relieving inflammatory conditions.
      The aim of our study is to verify the efficacy of a single Functional Therapy (FT) session to
      relieve inflammations, decreasing cortisol levels and activating the parasympathetic nervous
      system in healthy subjects after the administration of an acute stress such as the Trier
      Social Stress Test (TSST) protocol. After a psychiatric, psychological and anthropometric
      assessment, participants are randomly assigned to FT or attention placebo control group. The
      FT session lasting for 30 minutes and is conducted by therapists specialized in the MBT. The
      treatment's efficacy in reducing inflammatory states is verified by measuring the variations
      of the hearth rate, skin conductance, electromyography, pro-inflammatory cytokines (IL-6,
      TNFα, IL1β), anti-inflammatory cytokine (IL-10), and salivary cortisol; furthermore, the
      State Trait Anxiety Inventory (STAI) (state and trait) and Subjective Units of Distress Scale
      (SUDS) questionnaires are used as psychometric measures of anxiety and stress. All the
      participants are tested at baseline, at the end of TSST, at the end of the FT or audiobook
      session, and at follow-up 30 minutes after the session.
    

Detailed description: 
      Life's dynamics in modern societies expose the individuals to high level of suffering and
      stress, which can affect both psychological and physiological well-being. Numerous scientific
      evidences showed the correlation between stress and immunity system dysregulation. The
      exposure to acute and\or chronic mental stress conditions can alter the physiological
      functions of the organism, through the activation of sympathetic nervous system (SNS) and the
      inhibition of the parasympathetic nervous system (PNS). The activation of peripheral and
      central immune-inflammatory pathways is indicated by increased levels of proinflammatory
      cytokines, such as Interleukin-1 β (IL-1β), Interleukin-6 (IL-6), and Tumor necrosis factor-α
      (TNFα). Furthermore, experiencing high stress levels may lead to a disruption of the
      Hypothalamic-Pituitary-Adrenal (HPA) axis, with consequent increasing of cortisol's level,
      low-grade systemic inflammation and oxidative stress. These results correlate with the
      develop and progression of a wide range of pathological conditions, such as cardiovascular
      disease, Type II diabetes, arthritis, osteoporosis, Alzheimer's disease, and depression. In
      addition, inflammation is now considered as a risk factor for most cancers' disease,
      promoting pathological mechanism such as proliferation, angiogenesis and metastases.

      The last 20 years has seen an exponential growth of the mind-body techniques (MBT), an
      heterogeneous group of exercises and techniques focusing the life-styles, which has
      demonstrated validity in the reduction of psychological stress and inflammatory states. The
      techniques adopted by the clinical trials available include Yoga, Mindfulness, Tai Chi Chih,
      and Qigong; these protocols last usually from 4 to 12 weeks, and have been applied on
      clinical samples ranging on heterogeneous pathological conditions. However, the techniques
      used in the majority of these studies are derived from eastern meditative tradition and were
      not primarily developed to carrying out anti-inflammatory effects. Furthermore, the data
      concerning the effects of a single session of MBT under controlled experimental conditions
      are still lacking. In this regard, the Functional Therapy (FT) approach, an integrated
      body-mind therapy developed around the knowledges of psychoneuroimmunology (PNI), represents
      a potentially effective and specific methodology to counteract the physiological and
      psychological effects caused by prolonged exposure to stress conditions.

      Given these premises, the aim of this clinical trial is to verify the efficacy of a single
      Functional Therapy (FT) session to relieve inflammations, decreasing cortisol levels and
      activating the parasympathetic nervous system in healthy subjects after the administration of
      an acute stress such as the Trier Social Stress Test (TSST).

      Patients will be recruited starting in October 2019, via advertisement posted in university
      classrooms and premises. Researchers planned to recruit a sample of 40 participants. For the
      recruitment a structured telephone screening will help the researchers to investigate on some
      exclusion criteria. Then a consultation with a clinical psychologist and a psychiatrist will
      be programmed together with the administration of the psychological tests. Psychological
      assessment includes an ad-hoc sociodemographic questionnaire; a shortened version of Wechsler
      Adult Intelligence Scale - Revised (WAIS-R); Millon Clinical Multiaxial Inventory-III
      (MCMI-III); and Stress-related Vulnerability Scale (SVS). All these assessments will take
      place in the outpatient clinic of the policlinic "P. Giaccone", Palermo. After the
      assessment, eligible subjects will be randomized in the FT group or in the attention control
      group (AC), and will be assigned to the next therapist on a time capacity list.

      All the sessions will be taking place in the Neo-Functional Psychotherapy Centre of Palermo.
      During the session, participants will be assessed for anthropometric, psychological,
      biofeedback and salivary parameters. Anthropometric parameters include height, weight, and
      BMI; Psychological assessment includes the State-Trait Anxiety Inventory, in both trait and
      state form; and Subjective Unit of Distress Scale. Biofeedback parameters include hearth
      rate, skin conductance, and electromyography. Salivary measurements include pro-inflammatory
      cytokines (IL-6, TNFα, IL1β), anti-inflammatory cytokine (IL-10), and cortisol.

      Upon arrival, the anthropometric parameters will be assessed, thus biofeedback sensors will
      be connected to participants and it will record, for 5 minutes, the physiological parameters
      that will constitute the baseline; biofeedback sensors will remain online for the whole
      duration of the clinical trial. During this phase the STAI (trait and state) and SUDS
      questionnaires will be administered, and the first salivary samples will be taken for
      cortisol and cytokines.

      Then, participants will be submitted to the TSST social stress, a protocol used by
      researchers to induce stress under controlled condition. TSST is divided in 5 minutes
      components and the whole procedure lasts approximately 15 minutes; at the end, the second
      psychological and salivary assessments will be carried out.

      Participants will be randomized in FT group or AC group. Five different therapists with a
      4-year postgraduate training on functional approach will apply the FT session. The treatment
      was specifically manualized to reducing stress condition and to relieve inflammatory states.
      Specifically, the treatment includes a variety of functional techniques such as diaphragmatic
      breathing, and thoracic and abdominal manipulation, designed to stimulate the neurofunctional
      interconnection between body, mind and immune system. The FT session will last 30 minutes.
      The participants assigned to the AC will listen an audiobook lasting for 30 minutes, which
      will be used as attention placebo control activity. At the end of the session, the third
      psychological and salivary assessments will be carried out.

      Finally, all the participants will be undergoing to a follow-up phase, designed to assess the
      biofeedback and cytokines slow-responses to stress and relaxation procedures. Thus, subjects
      will be provided with an additionally 30 minutes session of audiobook listening, used as
      attention control placebo. At the end of the session, the fourth psychological and salivary
      assessments will be carried out.
    

Intervention name(s): Functional Therapy
Intervention type(s): Behavioral
Intervention description(s): It consists in a group of body-mind techniques based on functional theory developed in Italy by prof. Luciano Rispoli. These techniques are oriented to stimulate a diaphragmatic breathing though a thoracic and abdominal manipulation, with the aim to activate the parasympathetic nervous system and therefore reducing inflammation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After a psychiatric, psychological and anthropometric assessment, healthy volunteers will receive the Trier Social Stress Test (TSST) procedure and than they are randomly assigned to 30 min of deep diagrammatic breathing based on Functional therapy (FT) or attention control (AC). All subjects are tested at the baseline (T0), at the end of the TSST (T1), at the end of the treatment (T2) and 30 minutes after the treatment (T3)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep diaphragmatic breathing; cortisol; sympathetic nervous system; parasympathetic nervous system; inflammatory cytokines; Functional psychotherapy