The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People (MBTCC)

The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial

The trial aims to evaluate the effects of an integrated form of mindfulness-based Tai Chi Chuan (MBTCC) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Elderly; Mindfulness; Tai Chi Chuan
• Intervention / Treatment: Behavioral: Integrated mindfulness-based Tai Chi Chuan; Behavioral: Mindfulness-based intervention; Behavioral: Tai Chi Chuan; Behavioral: Sleep Hygiene Education

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Aged 60 years or above;
• Classified as experiencing sleep disturbances (indication of poor sleep quality through a score >5 in the Pittsburgh Sleep Quality Index);
• Primary education level or above and able to communicate in Cantonese;
• Able to give informed consent; and
• No previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).

Exclusion criteria:

• Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Integrated mindfulness-based Tai Chi Chuan; MBTCC	Behavioral: Integrated mindfulness-based Tai Chi Chuan; MBTCC will integrate components from both the MBI and TCC groups. The entire intervention consists of eight weekly sessions of two-and-a-half to three hours each.; Other Names: MBTCC
ACTIVE_COMPARATOR: Mindfulness-based intervention; MBI	Behavioral: Mindfulness-based intervention; The MBI group is mainly based on the basic theory and research of the foundational mindfulness-based stress reduction program. The intervention consists of eight weekly sessions of two to two-and-a-half hours each.; Other Names: MBI
ACTIVE_COMPARATOR: Tai Chi Chuan; TCC	Behavioral: Tai Chi Chuan; TCC is mainly based on a nine-form Yang-style form of TCC, which is a brief and modified version of 64-form Yang-style TCC. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.; Other Names: TCC
ACTIVE_COMPARATOR: Sleep Hygiene Education; SHE	Behavioral: Sleep Hygiene Education; SHE is based on principles used in stimulus control and sleep hygiene education, which has previously been used as the control group in sleep-related research. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.; Other Names: SHE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	at baseline (T1)
the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	In the 8th week from baseline (T2)
the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	six months after T2 (T3)
the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	one year after T2 (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Multidimensional Assessment of Interoceptive Awareness scale	The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.	at baseline (T1)
the Multidimensional Assessment of Interoceptive Awareness scale	The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.	In the 8th week from baseline (T2)
the Multidimensional Assessment of Interoceptive Awareness scale	The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.	six months after T2 (T3)
the Multidimensional Assessment of Interoceptive Awareness scale	The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.	one year after T2 (T4)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)	Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.	at baseline (T1)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)	Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.	In the 8th week from baseline (T2)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)	Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.	six months after T2 (T3)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)	Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.	one year after T2 (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	at baseline (T1)
the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	In the 8th week from baseline (T2)
the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	six months after T2 (T3)
the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	one year after T2 (T4)
the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	at baseline (T1)
the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	In the 8th week from baseline (T2)
the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	six months after T2 (T3)
the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	one year after T2 (T4)
the hyperarousal scale	A higher score suggests a higher arousal level.	at baseline (T1)
the hyperarousal scale	A higher score suggests a higher arousal level.	In the 8th week from baseline (T2)
the hyperarousal scale	A higher score suggests a higher arousal level.	six months after T2 (T3)
the hyperarousal scale	A higher score suggests a higher arousal level.	one year after T2 (T4)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Food and Health Bureau, Hong Kong

Publications and helpful links

General Publications

• Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2022
• Primary Completion (ANTICIPATED): April 18, 2025
• Study Completion (ANTICIPATED): April 18, 2025

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (ACTUAL): May 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: HSEARS20210331002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No