MT Combined With XKSA for Depressive Symptoms During COVID-19

NCT05631145 | Completed

• 1 other identifier: MTXKSA
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  Before and after 2-week treatment immediately.

Study Arms (2)

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

EXPERIMENTAL

MT combined with XKSA for 2 weeks.

Other: MT Combined With XKSA

Morita therapy (MT)

PLACEBO COMPARATOR

MT alone for 2 weeks

Other: MT

Interventions

MT Combined With XKSA 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) combined with Xingnao Kaiqiao self-administered acupressure (XKSA)

MT OTHER

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

Morita therapy (MT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renrong Wu: lead

Study Sites (1)

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

Shenzhen, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jing Huang, M.D. Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Model Details: Randomized controlled clinical trial testing MT combined with XKSA versus MT alone.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: November 30, 2022
• Study Start: May 3, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 15, 2020
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CN (1)