MT Combined With XKSA for Depressive Symptoms During COVID-19

NCT ID: NCT05631145

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-03
• Study Completion Date: 2020-10-15

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).

Conditions

Depression, Anxiety

Keywords

Morita therapy; acupressure; quarantine; COVID-19; depression; anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

MT combined with XKSA for 2 weeks.

Group Type: EXPERIMENTAL

MT Combined With XKSA

Intervention Type: OTHER

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.

Morita therapy (MT)

MT alone for 2 weeks

Group Type: PLACEBO_COMPARATOR

MT

Intervention Type: OTHER

Morita therapy (MT) comprised bed rest and light work.

Interventions

MT Combined With XKSA

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

MT

Morita therapy (MT) comprised bed rest and light work.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. age 18 to 65 years;

2. a PHQ-9 score of > 4 (indicative of mild depression);

3. shinkeishitsu-type neurosis including introspective, sensitive, serious, careful, timid, cautious, perfectionistic, or rigid character, assessed by the Diagnostic Interview of Morita shinkeishitsu (DIM);

4. absence of any problems involving injuries, inflammation, or space-occupying lesions at the locations of the acupoints;

5. ability to understand the trial process;

6. 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

1. severe physical and psychiatric diseases;

2. inability to complete the trial or use necessary psychiatric medicine;

3. cognitive dysfunction caused by neurodegenerative and neurodevelopmental disorders, such as dementia, mental retardation, and autism spectrum disorder;

4. self-injurious or suicidal risk;

5. positive COVID-19 nucleic acid test results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renrong Wu

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jing Huang, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

Shenzhen, , China

Countries

China

Other Identifiers

MTXKSA

Identifier Type: -

Identifier Source: org_study_id