Clinical trial NCT05631145: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Morita therapy
acupressure
quarantine
COVID-19
depression
anxiety
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial testing MT combined with XKSA versus MT alone.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes in the Patient Health Questionnaire 9-item depression scale (PHQ-9)
timeFrame: Before and after 2-week treatment immediately.
measure: Changes in the Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Before and after 2-week treatment immediately.
measure: Changes in the Insomnia Severity Index (ISI)
timeFrame: Before and after 2-week treatment immediately.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Study officials:
affiliation: Central South University
name: Jing Huang, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: