The Efficacy of Acupressure Therapy on Patient With Depression (Akupress)

Efficacy of Acupressure in Depression as Non-invasive Nursing Intervention - a Randomized Single-blind Trial With Psychological and Physiological Criteria

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder; Depressive Symptoms; Depressive Disorder, Major
• Intervention / Treatment: Other: Acupressure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamdy Shaban, PhD; Phone Number: +41 (0)61 325 54 01; Email: hamdy.shaban@upk.ch
• Study Contact Backup: Name: Regina Komminoth, MS; Phone Number: +41 (0)61 325 54 01; Email: regina.komminoth@upk.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; Treatment as usual with pharmacotherapy and other complementary therapies
Sham Comparator: Sham; No actual acupoint pressed but same settings as in acupressure therapy	Other: Acupressure; selected acupoint pressure; Other Names: TCM
Experimental: Intervention; Treatment as usual plus acupressure intervention with selected acupoints pressure	Other: Acupressure; selected acupoint pressure; Other Names: TCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline self reported Depression Severity	Beck Depression Inventory BDI (Max score >40 High depression, Min score < 10 Normal)	with 2 month
Change from Baseline Depression Severity	Hamilton Depression Rating Scale HDRS (Max score >18 Severe (moderate) depression, Min < 7 no depression)	with 2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline heart rate	Change in resting heart rate	with 2 month
Change from baseline blood pressure	Change in systolic blood pressure	with 2 month

Collaborators and Investigators

• Sponsor: University Psychiatric Clinics Basel

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: Akupressur-Therapie

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No