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The Efficacy of Acupressure Therapy on Patient With Depression

Not Applicable
Not yet recruiting
Conditions
Depressive Disorder, Major
Depressive Disorder
Depressive Symptoms
Interventions
Other: Acupressure
Registration Number
NCT05423405
Lead Sponsor
University Psychiatric Clinics Basel
Brief Summary

A new nursing intervention with non-invasive acupressure protocol for activation of parasympathetic nervous system to reduce stress related depression symptoms.

Detailed Description

Acupressure is a treatment method in which manual pressure is applied to specific points or areas of the body. According to the principles of Traditional Chinese Medicine (TCM), these acupuncture points are stimulated along the energy channels (meridians) of the body. Finger pressure is mainly used here, in some cases also with a relaxing massage. According to TCM, this can stimulate the energy flow of the Qi. The therapist also tries to treat energetic blockages. Acupuncture is recommended for psychological problems, pain syndromes and sleep disorders, among other things.

Acupressure has been established as an additional therapy offer in private department J of the UPK since the beginning of 2021. Patients with depression and anxiety disorders subjectively benefit from the treatment in terms of reducing stress symptoms and improving relaxation.

Although patient acceptance is high, there are no high-quality studies on accompanying acupressure as part of standard treatments for depression, anxiety or sleep disorders. Their effectiveness in psychiatric patients is therefore controversial. Although there are few studies from "Western medicine" institutions, most of the clinical studies were carried out by Chinese colleagues. In most cases, only subjective assessment instruments were used to assess effectiveness without evaluating objective biomarker measurements such as cortisol concentration, brain-derived neurotrophic factor (BDNF) or cytokines.

A hypothesis on the effectiveness of acupressure in western medicine has not been established. The vagus nerve stimulation may play a role and thus the activation of the parasympathetic nervous system - which in turn could lead to a reduction in stress symptoms and an increase in relaxation and regeneration in the short and/or medium term. The role of the social bonding hormone oxytocin has not been studied so far.

The aim of this study is to evaluate the efficacy of acupressure adjunctive therapy in Major Depressive Disorder (MDD) as part of evidence-based treatment as usual (TAU) as a randomized, single-blind study.

Physiological and psychological assessment instruments should be used: cortisol levels in the saliva; serum oxytocin and BDNF levels; Heart rate variability, Hamilton Depression Rating Scale (HAM-D; third-party rating scale) and Beck Depression Inventory-II (BDI-II, self-rating scale).

The acupressure therapy protocol specially developed in the UPK could thus be established as a non-invasive, non-drug nursing therapy tool and achieve scientifically sound application in the UPK and other clinics, provided that proof of effectiveness is achieved.

We are pursuing a long-term strategy with our study because we are convinced that the current treatment options for depression are not sufficient and could be supplemented and improved by innovative and complementary therapies. Acupuncture can play a helpful role as an easily accessible and inexpensive method.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Age 18-80
  • Primary diagnosis of MDD with a current moderate-to-severe episode (HAM-D score > 16) 55
  • Treatment as usual for depression
  • Able to read and understand study procedures and participant's information
  • Agree to receive acupressure therapy
Exclusion Criteria
  • Suicidal ideation
  • Antipsychotic medication
  • Primary diagnosis other than MDD
  • Contradiction for acupressure (skin diseases, pregnancy)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionAcupressureTreatment as usual plus acupressure intervention with selected acupoints pressure
ShamAcupressureNo actual acupoint pressed but same settings as in acupressure therapy
Primary Outcome Measures
NameTimeMethod
Change from baseline self reported Depression Severitywith 2 month

Beck Depression Inventory BDI (Max score \>40 High depression, Min score \< 10 Normal)

Change from Baseline Depression Severitywith 2 month

Hamilton Depression Rating Scale HDRS (Max score \>18 Severe (moderate) depression, Min \< 7 no depression)

Secondary Outcome Measures
NameTimeMethod
Change from baseline heart ratewith 2 month

Change in resting heart rate

Change from baseline blood pressurewith 2 month

Change in systolic blood pressure

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