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NCT Number: NCT04840043

Osteopathic Sympathetic Harmonization and Depression

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.

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Key information

Conditions

Osteopathic Manipulative Treatment Behavior Behavioral Symptoms Depression

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic sympathic harmonization

Other

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.

Sham intervention

Other

Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

Primary outcomes

  1. The Beck Depression Inventory (BDI)

    Time frame: Before intervention

    The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  2. The State-Trait Anxiety Inventory (STAI) Form - 1

    Time frame: Before intervention

    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.

  3. Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes

    Time frame: Before intervention, immediately after the intervention, 20 minutes after the intervention

    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.

  4. Change from Baseline Heart rate and blood pressure measurements at 20 minutes

    Time frame: Before intervention, immediately after the intervention, 20 minutes after the intervention

    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

  5. Change from Baseline Salivary Biomarkers at 20 minutes

    Time frame: Before intervention, immediately after the intervention, 20 second after the intervention

    Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.

  6. Demographic data

    Time frame: Before intervention

    Sex; male or female

  7. Demographic data

    Time frame: Before intervention

    Age; years

  8. Demographic data

    Time frame: Before intervention

    Height (m); weight (kg); body mass index (kg/m2)

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 9, 2021
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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