The Efficacy of Acupressure Therapy on Patient With Depression (Akupress)
Primary Purpose
Depressive Disorder, Depressive Disorder, Major, Depressive Symptoms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Depressive Disorder
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Sham Comparator
Experimental
Arm Label
control
Sham
Intervention
Arm Description
Treatment as usual with pharmacotherapy and other complementary therapies
No actual acupoint pressed but same settings as in acupressure therapy
Treatment as usual plus acupressure intervention with selected acupoints pressure
Outcomes
Primary Outcome Measures
Change from baseline self reported Depression Severity
Beck Depression Inventory BDI (Max score >40 High depression, Min score < 10 Normal)
Change from Baseline Depression Severity
Hamilton Depression Rating Scale HDRS (Max score >18 Severe (moderate) depression, Min < 7 no depression)
Secondary Outcome Measures
Change from baseline heart rate
Change in resting heart rate
Change from baseline blood pressure
Change in systolic blood pressure
Full Information
NCT ID
NCT05423405
First Posted
June 9, 2022
Last Updated
June 14, 2022
Sponsor
University Psychiatric Clinics Basel
1. Study Identification
Unique Protocol Identification Number
NCT05423405
Brief Title
The Efficacy of Acupressure Therapy on Patient With Depression
Acronym
Akupress
Official Title
Efficacy of Acupressure in Depression as Non-invasive Nursing Intervention - a Randomized Single-blind Trial With Psychological and Physiological Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Psychiatric Clinics Basel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depressive Disorder, Major, Depressive Symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients population with depression (mild, moderate, or severe)
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Treatment as usual with pharmacotherapy and other complementary therapies
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
No actual acupoint pressed but same settings as in acupressure therapy
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Treatment as usual plus acupressure intervention with selected acupoints pressure
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
TCM
Intervention Description
selected acupoint pressure
Primary Outcome Measure Information:
Title
Change from baseline self reported Depression Severity
Description
Beck Depression Inventory BDI (Max score >40 High depression, Min score < 10 Normal)
Time Frame
with 2 month
Title
Change from Baseline Depression Severity
Description
Hamilton Depression Rating Scale HDRS (Max score >18 Severe (moderate) depression, Min < 7 no depression)
Time Frame
with 2 month
Secondary Outcome Measure Information:
Title
Change from baseline heart rate
Description
Change in resting heart rate
Time Frame
with 2 month
Title
Change from baseline blood pressure
Description
Change in systolic blood pressure
Time Frame
with 2 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdy Shaban, PhD
Phone
+41 (0)61 325 54 01
Email
hamdy.shaban@upk.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Komminoth, MS
Phone
+41 (0)61 325 54 01
Email
regina.komminoth@upk.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Efficacy of Acupressure Therapy on Patient With Depression
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