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MT Combined With XKSA for Depressive Symptoms During COVID-19

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MT Combined With XKSA
MT
Sponsored by
Renrong Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety focused on measuring Morita therapy, acupressure, quarantine, COVID-19, depression, anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 18 to 65 years; a PHQ-9 score of > 4 (indicative of mild depression); shinkeishitsu-type neurosis including introspective, sensitive, serious, careful, timid, cautious, perfectionistic, or rigid character, assessed by the Diagnostic Interview of Morita shinkeishitsu (DIM); absence of any problems involving injuries, inflammation, or space-occupying lesions at the locations of the acupoints; ability to understand the trial process; no engagement in other forms of activities to improve mood and sleep (e.g., Tai Chi, yoga, and mindfulness meditation) in the last three months before and during the trial. Exclusion Criteria: severe physical and psychiatric diseases; inability to complete the trial or use necessary psychiatric medicine; cognitive dysfunction caused by neurodegenerative and neurodevelopmental disorders, such as dementia, mental retardation, and autism spectrum disorder; self-injurious or suicidal risk; positive COVID-19 nucleic acid test results.

Sites / Locations

  • Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA)

Morita therapy (MT)

Arm Description

MT combined with XKSA for 2 weeks.

MT alone for 2 weeks

Outcomes

Primary Outcome Measures

Changes in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
The PHQ-9 is a self-report scale which scored each of the DSM-IV diagnostic criteria for major depressive disorders (MDD) from 0 (not at all) to 3 (nearly every day) and total scores of 5, 10, 15, 20 represent mild, moderate, moderately severe, and severe depression, respectively.
Changes in the Generalized Anxiety Disorder 7-item (GAD-7)
The GAD-7, comprising seven items scored from 0 to 3 each, is a self-rating scale for generalized anxiety disorder. A total score of 5, 10, or 15 indicated mild, moderate, or severe anxiety symptoms, respectively
Changes in the Insomnia Severity Index (ISI)
The ISI could evaluate the severity of current insomnia problems with 7 self-rating items involving staying asleep, falling asleep, waking early morning, noticeability of these problems, distress and daily functioning interference caused by these problems, and sleep satisfaction. A total score ranged from 0 to 28 and cutoff points of 8, 15, and 22 representing subthreshold, moderate, and severe insomnia, respectively

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
November 29, 2022
Sponsor
Renrong Wu
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1. Study Identification

Unique Protocol Identification Number
NCT05631145
Brief Title
MT Combined With XKSA for Depressive Symptoms During COVID-19
Official Title
Morita Therapy Combined With Xingnao Kaiqiao Acupressure for Relieving Depressive Symptoms During COVID-19: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Renrong Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Social isolation related mental health problems have raised many concerns during the COVID-19 outbreaks. Mental health care for people in quarantined hotels is in urgent need, but concrete program is rarely reported. Morita therapy and acupressure have been identified as effective treatments for regulating mood and sleep. The study aimed to examine whether Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA) could improve depressive, anxiety symptoms and sleep quality in isolated people with depressive symptoms.
Detailed Description
The study will evaluate the efficacy and safety of Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA) on ameliorating depressive, anxiety and insomnia symptoms in quarantined people with depressive symptoms by measuring changes in clinical ratings before and after all the treatments immediately. 59 participants will be randomized to receive self-administered acupressure combined with Morita therapy or Morita therapy monotherapy during the two weeks of clinical observation and quarantine in Shenzhen, China. Morita therapy (MT) comprised bed rest and light work. In the first week, the participants were instructed to stay in the room but not restrict themselves to the bed. In the second week, the therapist guided the participants to face or accept instead of deliberately eliminating negative emotions and somatic discomfort. Xingnao Kaiqiao self-administered acupressure (XKSA) protocol evolved based on the XK acupuncture techniques after consulting a Chinese medicine specialist. Other two traditional Chinese medicine experts reviewed and approved the protocol. The protocol comprised pressing nine acupoints including Baihui, Sishenchong, Shenmen, Neiguan, Hegu, Taichong, Jianjing, Shenshu, and Yuji. Changes in depressive symptoms from baseline to the end of the study will be measured by the Patient Health Questionnaire 9-item depression scale (PHQ-9). Changes in anxiety symptoms from baseline to the end of the study will be measured by the Generalized Anxiety Disorder 7-item (GAD-7). Changes in sleep quality from baseline to the end of the study will be measured by the Insomnia Severity Index (ISI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Morita therapy, acupressure, quarantine, COVID-19, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial testing MT combined with XKSA versus MT alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA)
Arm Type
Experimental
Arm Description
MT combined with XKSA for 2 weeks.
Arm Title
Morita therapy (MT)
Arm Type
Placebo Comparator
Arm Description
MT alone for 2 weeks
Intervention Type
Other
Intervention Name(s)
MT Combined With XKSA
Intervention Description
Morita therapy (MT) comprised bed rest and light work. Xingnao Kaiqiao self-administered acupressure (XKSA) stimulates nine acupoints including Baihui, Sishenchong, Shenmen, Neiguan, Hegu, Taichong, Jianjing, Shenshu, and Yuji.
Intervention Type
Other
Intervention Name(s)
MT
Intervention Description
Morita therapy (MT) comprised bed rest and light work.
Primary Outcome Measure Information:
Title
Changes in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
Description
The PHQ-9 is a self-report scale which scored each of the DSM-IV diagnostic criteria for major depressive disorders (MDD) from 0 (not at all) to 3 (nearly every day) and total scores of 5, 10, 15, 20 represent mild, moderate, moderately severe, and severe depression, respectively.
Time Frame
Before and after 2-week treatment immediately.
Title
Changes in the Generalized Anxiety Disorder 7-item (GAD-7)
Description
The GAD-7, comprising seven items scored from 0 to 3 each, is a self-rating scale for generalized anxiety disorder. A total score of 5, 10, or 15 indicated mild, moderate, or severe anxiety symptoms, respectively
Time Frame
Before and after 2-week treatment immediately.
Title
Changes in the Insomnia Severity Index (ISI)
Description
The ISI could evaluate the severity of current insomnia problems with 7 self-rating items involving staying asleep, falling asleep, waking early morning, noticeability of these problems, distress and daily functioning interference caused by these problems, and sleep satisfaction. A total score ranged from 0 to 28 and cutoff points of 8, 15, and 22 representing subthreshold, moderate, and severe insomnia, respectively
Time Frame
Before and after 2-week treatment immediately.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 65 years; a PHQ-9 score of > 4 (indicative of mild depression); shinkeishitsu-type neurosis including introspective, sensitive, serious, careful, timid, cautious, perfectionistic, or rigid character, assessed by the Diagnostic Interview of Morita shinkeishitsu (DIM); absence of any problems involving injuries, inflammation, or space-occupying lesions at the locations of the acupoints; ability to understand the trial process; no engagement in other forms of activities to improve mood and sleep (e.g., Tai Chi, yoga, and mindfulness meditation) in the last three months before and during the trial. Exclusion Criteria: severe physical and psychiatric diseases; inability to complete the trial or use necessary psychiatric medicine; cognitive dysfunction caused by neurodegenerative and neurodevelopmental disorders, such as dementia, mental retardation, and autism spectrum disorder; self-injurious or suicidal risk; positive COVID-19 nucleic acid test results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D. Ph.D
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
City
Shenzhen
Country
China

12. IPD Sharing Statement

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MT Combined With XKSA for Depressive Symptoms During COVID-19

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