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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05396092
Collaborator
Food and Health Bureau, Hong Kong (Other)
256
1
4
36
7.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Integrated mindfulness-based Tai Chi Chuan
  • Behavioral: Mindfulness-based intervention
  • Behavioral: Tai Chi Chuan
  • Behavioral: Sleep Hygiene Education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Apr 18, 2025
Anticipated Study Completion Date :
Apr 18, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. the Insomnia Severity Index [at baseline (T1)]

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

    2. the Insomnia Severity Index [In the 8th week from baseline (T2)]

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

    3. the Insomnia Severity Index [six months after T2 (T3)]

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

    4. the Insomnia Severity Index [one year after T2 (T4)]

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

    Secondary Outcome Measures

    1. the Multidimensional Assessment of Interoceptive Awareness scale [at baseline (T1)]

      The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    2. the Multidimensional Assessment of Interoceptive Awareness scale [In the 8th week from baseline (T2)]

      The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    3. the Multidimensional Assessment of Interoceptive Awareness scale [six months after T2 (T3)]

      The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    4. the Multidimensional Assessment of Interoceptive Awareness scale [one year after T2 (T4)]

      The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    5. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA) [at baseline (T1)]

      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.

    6. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA) [In the 8th week from baseline (T2)]

      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.

    7. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA) [six months after T2 (T3)]

      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.

    8. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA) [one year after T2 (T4)]

      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.

    Other Outcome Measures

    1. the Chinese (Hong Kong) Short-Form-12 [at baseline (T1)]

      A higher respective summary score indicates better levels of health.

    2. the Chinese (Hong Kong) Short-Form-12 [In the 8th week from baseline (T2)]

      A higher respective summary score indicates better levels of health.

    3. the Chinese (Hong Kong) Short-Form-12 [six months after T2 (T3)]

      A higher respective summary score indicates better levels of health.

    4. the Chinese (Hong Kong) Short-Form-12 [one year after T2 (T4)]

      A higher respective summary score indicates better levels of health.

    5. the rumination subscale from the Rumination-Reflection Questionnaire [at baseline (T1)]

      A higher score suggests greater ruminative tendencies.

    6. the rumination subscale from the Rumination-Reflection Questionnaire [In the 8th week from baseline (T2)]

      A higher score suggests greater ruminative tendencies.

    7. the rumination subscale from the Rumination-Reflection Questionnaire [six months after T2 (T3)]

      A higher score suggests greater ruminative tendencies.

    8. the rumination subscale from the Rumination-Reflection Questionnaire [one year after T2 (T4)]

      A higher score suggests greater ruminative tendencies.

    9. the hyperarousal scale [at baseline (T1)]

      A higher score suggests a higher arousal level.

    10. the hyperarousal scale [In the 8th week from baseline (T2)]

      A higher score suggests a higher arousal level.

    11. the hyperarousal scale [six months after T2 (T3)]

      A higher score suggests a higher arousal level.

    12. the hyperarousal scale [one year after T2 (T4)]

      A higher score suggests a higher arousal level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hong Kong Polytechnic University Kowloon Hong Kong

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University
    • Food and Health Bureau, Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT05396092
    Other Study ID Numbers:
    • HSEARS20210331002-01
    First Posted:
    May 31, 2022
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 31, 2022