Depression, AnxietyNCT05631145
MT Combined With XKSA for Depressive Symptoms During COVID-19
A study testing MT Combined With XKSA and MT in people with Depression, Anxiety, run by Renrong Wu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- MT Combined With XKSA and MT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Shenzhen
About this study
Official title: Morita Therapy Combined With Xingnao Kaiqiao Acupressure for Relieving Depressive Symptoms During COVID-19: A Randomized Controlled Study
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.
Read the 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).
- Conditions
- Depression, Anxiety
- Being tested
- MT Combined With XKSA, MT
- Keywords
- Morita therapy, acupressure, quarantine, COVID-19, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT Combined With XKSAOther
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.
MTOther
Morita therapy (MT) comprised bed rest and light work.
| Study group | Role | What they receive |
|---|---|---|
| Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA) | Experimental | MT combined with XKSA for 2 weeks. Receives: Other: MT Combined With XKSA |
| Morita therapy (MT) | Placebo comparator | MT alone for 2 weeks Receives: Other: MT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 2-week treatment immediately.
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
Measured: Before and after 2-week treatment immediately.
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
Measured: Before and after 2-week treatment immediately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start3 May 2020
- Primary completion1 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial testing MT combined with XKSA versus MT alone.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renrong Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renrong Wu, Central South University
- Investigators
- Jing Huang, M.D. Ph.D, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631145
- Sponsor's protocol ID
- MTXKSA
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morita Therapy Combined With Xingnao Kaiqiao Acupressure for Relieving Depressive Symptoms During COVID-19: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05631145
- Acronym / sponsor ID
- MTXKSA
- Conditions
- Depression, Anxiety
- Keywords
- Morita therapy, acupressure, quarantine, COVID-19, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Renrong WuUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial testing MT combined with XKSA versus MT alone.
| Arm | Type | Receives |
|---|---|---|
| Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA) | Experimental | Other: MT Combined With XKSAMT combined with XKSA for 2 weeks. |
| Morita therapy (MT) | Placebo comparator | Other: MTMT alone for 2 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT Combined With XKSAMorita 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. | Other | Morita therapy (MT) combined with Xingnao Kaiqiao self-administered acupressure (XKSA) |
| MTMorita therapy (MT) comprised bed rest and light work. | Other | Morita therapy (MT) |
Primary outcome
Changes in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
Time frame: Before and after 2-week treatment immediately.
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)
Time frame: Before and after 2-week treatment immediately.
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)
Time frame: Before and after 2-week treatment immediately.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Huang, M.D. Ph.D principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT Combined With XKSA and MT in people with Depression, Anxiety, run by Renrong Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Patient Health Questionnaire 9-item depression scale (PHQ-9) (time frame: Before and after 2-week treatment immediately.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.