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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
University Psychiatric Clinics Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depressive Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 9, 2022
    Last Updated
    June 14, 2022
    Sponsor
    University Psychiatric Clinics Basel
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    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

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    The Efficacy of Acupressure Therapy on Patient With Depression

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