Osteopathic Sympathetic Harmonization and Depression

Study Overview
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Brief Summary
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Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.

Detailed Description
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Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.

Official Title
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Assessment of Effectiveness of the Osteopathic Sympathetic Harmonization Applications on the Sympathetic Nervous System and the HPA Axis With Depression Diagnosed Adolescents: A Double-blind, Placebo-controlled, Randomized Study

Conditions
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Osteopathic Manipulative Treatment

Intervention / Treatment
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* Other: Osteopathic sympathic harmonization
* Other: Sham intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria Volunteering to participate in the study Exclusion Criteria: Fever over 38.5 Acute injury or infection Rib fracture Cardiac arrhythmia Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.) Being pregnant, premenstrual or in the menstrual period for female participants

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind, placebo-controlled, randomized study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathy Group<br>Stimulation on the sympathetic truncus and prevertebral ganglia | Other: Osteopathic sympathic harmonization<br>* Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.<br>|
| Sham Comparator: Control Group<br>Stimulation on similar areas with lighter touch and shorter duration | Other: Sham intervention<br>* Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. | Before intervention | 
| The State-Trait Anxiety Inventory (STAI) Form - 1 | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. | Before intervention | 
| Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. | Before intervention, immediately after the intervention, 20 minutes after the intervention | 
| Change from Baseline Heart rate and blood pressure measurements at 20 minutes | Heart rate (beats per minute) and blood pressure (mm/Hg) were measured with automatic blood pressure monitor (the Microlife BP 3BT0-A). It is a clinically validated and 1-star automatic blood pressure monitor | Before intervention, immediately after the intervention, 20 minutes after the intervention | 
| Change from Baseline Salivary Biomarkers at 20 minutes | Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay. | Before intervention, immediately after the intervention, 20 second after the intervention | 
| Demographic data | Sex; male or female | Before intervention | 
| Demographic data | Age; years | Before intervention | 
| Demographic data | Height (m); weight (kg); body mass index (kg/m2) | Before intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Sympathetic nervous system, Cortisol