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

Study Overview
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Brief Summary
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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.

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

Conditions
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Elderly, Sleep, Mindfulness, Tai Chi Chuan

Intervention / Treatment
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* Behavioral: Integrated mindfulness-based Tai Chi Chuan
* Behavioral: Mindfulness-based intervention
* Behavioral: Tai Chi Chuan
* Behavioral: Sleep Hygiene Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated mindfulness-based Tai Chi Chuan<br>MBTCC | Behavioral: Integrated mindfulness-based Tai Chi Chuan<br>* 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.<br>* Other names: MBTCC;|
| Active Comparator: Mindfulness-based intervention<br>MBI | Behavioral: Mindfulness-based intervention<br>* 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.<br>* Other names: MBI;|
| Active Comparator: Tai Chi Chuan<br>TCC | Behavioral: Tai Chi Chuan<br>* 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.<br>* Other names: TCC;|
| Active Comparator: Sleep Hygiene Education<br>SHE | Behavioral: Sleep Hygiene Education<br>* 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.<br>* Other names: SHE;|

What is the study measuring?
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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) |