Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs

NCT05482646 | Completed

• 1 other identifier: TaiChiTrialHKU2020
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.

Conditions

Depressive Symptoms; Chronic Insomnia

Keywords

Exercise; Tai Chi; Elderly; Depression; Insomnia

Outcome Measures

Primary Outcomes (2)

• Hospital Anxiety and Depression Scale - Depression

  The depression score of the Hospital Anxiety and Depression Scale (HADS-D) will be used to evaluate the severity of depressive symptoms. This consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of more severe depressive symptoms.

  3 months (post-intervention)

• Hospital Anxiety and Depression Scale - Depression

  The depression score of the Hospital Anxiety and Depression Scale (HADS-D) will be used to evaluate the severity of depressive symptoms. This consists of a seven-item questionnaire with an overall score ranging from 0 to 21. Higher scores are indicative of more severe depressive symptoms.

  9 months (6 months post-intervention follow-up)

Secondary Outcomes (20)

• Insomnia severity index

  3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

• Pittsburgh Sleep Quality Index

  3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

• Patient Health Questionnaire

  3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

• General Anxiety Disorder Scale

  3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

• Hospital Anxiety and Depression Scale - Anxiety

  3 months (post-intervention) and 9 months (6 months post-intervention follow-up)

Study Arms (3)

Tai Chi

EXPERIMENTAL

This group will perform 3 months of Tai Chi training

Behavioral: Tai Chi

Conventional exercise

ACTIVE COMPARATOR

This group will perform 3 months of conventional exercise training

Behavioral: Conventional exercise

Health Education Control

OTHER

This group will participate in a 3-month health education program

Behavioral: Health Education Control

Interventions

Tai Chi BEHAVIORAL

The Tai Chi intervention will be prescribed as a 3-month program with two 1.5-h sessions weekly instructed by qualified Tai Chi instructors.

Tai Chi

Conventional exercise BEHAVIORAL

The conventional exercise intervention will be prescribed as a 3-month program with two 1.5-h sessions of generic fitness training weekly instructed by qualified instructors.

Conventional exercise

Health Education Control BEHAVIORAL

Participants in the control group will participate in a health education program delivered by research personnel.

Health Education Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Can communicate using Cantonese or Mandarin
• with mild-to-moderate depressive symptoms (HADS-depression score ≥8/21 and PHQ- 9 score ≤14/27)
• Fulfil the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for chronic insomnia including difficulties in initiating or maintaining sleep, early morning awakening with complaint of significant distress or impairment of daytime functioning, sleep difficulty occurring at least three nights per week and present for at least 3 months.

You may not qualify if:

• Somatic condition that prevents participation in tai chi or exercise
• Regular moderate-to-vigorous intensity exercise or mind-body training such as tai chi, yoga, qigong or meditation in the past 3 months
• Any form (or combination) of exercises amounting to 180 minutes per week in the past 3 months
• Dementia
• Diagnosis with schizophrenia or other psychotic disorders, bipolar disorders or alcohol/substance use/abuse
• Current usage or planning to use potentially confounding treatments, including herbal supplementations (e.g., St. John's Wort), acupuncture treatment, cognitive behavioral therapy or other psychotherapy, mind-body intervention (e.g., mindfulness training and muscle relaxation training) or muscle relaxants such as carisoprodol, cyclobenzaprine, diazepam
• Current suicidal or self-injurious potential that requires immediate clinical follow-up.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

LKS Faculty of Medicine, HKU

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Parco M Siu, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 1, 2022
• Study Start: August 2, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

HK (1)