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

Primary Purpose

Elderly, Sleep, Mindfulness

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Integrated mindfulness-based Tai Chi Chuan
Mindfulness-based intervention
Tai Chi Chuan
Sleep Hygiene Education
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Integrated mindfulness-based Tai Chi Chuan

Mindfulness-based intervention

Tai Chi Chuan

Sleep Hygiene Education

Arm Description

MBTCC

MBI

TCC

SHE

Outcomes

Primary Outcome Measures

the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 17, 2022
Last Updated
May 24, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05396092
Brief Title
The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 18, 2025 (Anticipated)
Study Completion Date
April 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Sleep, Mindfulness, Tai Chi Chuan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated mindfulness-based Tai Chi Chuan
Arm Type
Experimental
Arm Description
MBTCC
Arm Title
Mindfulness-based intervention
Arm Type
Active Comparator
Arm Description
MBI
Arm Title
Tai Chi Chuan
Arm Type
Active Comparator
Arm Description
TCC
Arm Title
Sleep Hygiene Education
Arm Type
Active Comparator
Arm Description
SHE
Intervention Type
Behavioral
Intervention Name(s)
Integrated mindfulness-based Tai Chi Chuan
Other Intervention Name(s)
MBTCC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Other Intervention Name(s)
MBI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chuan
Other Intervention Name(s)
TCC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Education
Other Intervention Name(s)
SHE
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Insomnia Severity Index
Description
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Time Frame
at baseline (T1)
Title
the Insomnia Severity Index
Description
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Time Frame
In the 8th week from baseline (T2)
Title
the Insomnia Severity Index
Description
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Time Frame
six months after T2 (T3)
Title
the Insomnia Severity Index
Description
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Time Frame
one year after T2 (T4)
Secondary Outcome Measure Information:
Title
the Multidimensional Assessment of Interoceptive Awareness scale
Description
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
Time Frame
at baseline (T1)
Title
the Multidimensional Assessment of Interoceptive Awareness scale
Description
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
Time Frame
In the 8th week from baseline (T2)
Title
the Multidimensional Assessment of Interoceptive Awareness scale
Description
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
Time Frame
six months after T2 (T3)
Title
the Multidimensional Assessment of Interoceptive Awareness scale
Description
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
Time Frame
one year after T2 (T4)
Title
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Description
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.
Time Frame
at baseline (T1)
Title
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Description
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.
Time Frame
In the 8th week from baseline (T2)
Title
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Description
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.
Time Frame
six months after T2 (T3)
Title
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Description
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.
Time Frame
one year after T2 (T4)
Other Pre-specified Outcome Measures:
Title
the Chinese (Hong Kong) Short-Form-12
Description
A higher respective summary score indicates better levels of health.
Time Frame
at baseline (T1)
Title
the Chinese (Hong Kong) Short-Form-12
Description
A higher respective summary score indicates better levels of health.
Time Frame
In the 8th week from baseline (T2)
Title
the Chinese (Hong Kong) Short-Form-12
Description
A higher respective summary score indicates better levels of health.
Time Frame
six months after T2 (T3)
Title
the Chinese (Hong Kong) Short-Form-12
Description
A higher respective summary score indicates better levels of health.
Time Frame
one year after T2 (T4)
Title
the rumination subscale from the Rumination-Reflection Questionnaire
Description
A higher score suggests greater ruminative tendencies.
Time Frame
at baseline (T1)
Title
the rumination subscale from the Rumination-Reflection Questionnaire
Description
A higher score suggests greater ruminative tendencies.
Time Frame
In the 8th week from baseline (T2)
Title
the rumination subscale from the Rumination-Reflection Questionnaire
Description
A higher score suggests greater ruminative tendencies.
Time Frame
six months after T2 (T3)
Title
the rumination subscale from the Rumination-Reflection Questionnaire
Description
A higher score suggests greater ruminative tendencies.
Time Frame
one year after T2 (T4)
Title
the hyperarousal scale
Description
A higher score suggests a higher arousal level.
Time Frame
at baseline (T1)
Title
the hyperarousal scale
Description
A higher score suggests a higher arousal level.
Time Frame
In the 8th week from baseline (T2)
Title
the hyperarousal scale
Description
A higher score suggests a higher arousal level.
Time Frame
six months after T2 (T3)
Title
the hyperarousal scale
Description
A higher score suggests a higher arousal level.
Time Frame
one year after T2 (T4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36153623
Citation
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.
Results Reference
derived

Learn more about this trial

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

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