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

Sleep Clinical Trial

— MBTCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396092
• Other study ID #: HSEARS20210331002-01
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: April 18, 2025

Study information

• Verified date: May 2022
• Source: The Hong Kong Polytechnic University
• Contact: Shu-Mei Wang, PhD
• Phone: 852-27664197
• Email: shumei.wang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: April 18, 2025
• Est. primary completion date: April 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Elderly
• Mindfulness
• Parasomnias
• Sleep

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	at baseline (T1)
Other	the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	In the 8th week from baseline (T2)
Other	the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	six months after T2 (T3)
Other	the Chinese (Hong Kong) Short-Form-12	A higher respective summary score indicates better levels of health.	one year after T2 (T4)
Other	the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	at baseline (T1)
Other	the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	In the 8th week from baseline (T2)
Other	the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	six months after T2 (T3)
Other	the rumination subscale from the Rumination-Reflection Questionnaire	A higher score suggests greater ruminative tendencies.	one year after T2 (T4)
Other	the hyperarousal scale	A higher score suggests a higher arousal level.	at baseline (T1)
Other	the hyperarousal scale	A higher score suggests a higher arousal level.	In the 8th week from baseline (T2)
Other	the hyperarousal scale	A higher score suggests a higher arousal level.	six months after T2 (T3)
Other	the hyperarousal scale	A higher score suggests a higher arousal level.	one year after T2 (T4)
Primary	the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	at baseline (T1)
Primary	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)
Primary	the Insomnia Severity Index	This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.	six months after T2 (T3)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)