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NCT Number: NCT06095037

Mindful Yoga for Older Adults and Caregivers

This study will adopt the intervention of mindful yoga to improve the psychological well-being of older adults who discharged from hospital and their caregivers in Hong Kong.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In the proposed study, the investigators will conduct a fully powered, double-blind, and multicentered randomized controlled trial (RCT) of the efficacy of mindful yoga versus a psychoeducation control. The study sample will consist of older adults discharged from hospitals within the previous 3 months and their informal caregivers. The investigators will aim to determine: (1) the efficacy of mindful yoga in the study group versus the control group in improving the dyadic psychological well-being (as measured by depression, anxiety, stress, and meaning of life) of older adult-caregiver dyads (e.g., both actor and partner effects); (2) whether these improvements were maintained after 3 and 6 months; and (3) the lived experiences of older adults and their caregivers. The investigators hypothesize that: (1) mindful yoga will be more efficacious in improving outcomes compared with the control condition; (2) there will be both actor and partner effects of the intervention on the primary and secondary outcomes; and (3) these outcome improvements will be maintained at 3 and 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Older adults discharged from hospital

  • older adults aged 65 years or above;
  • individuals who have been discharged from a local hospital within the previous 3 months who qualify for the Pilot Scheme on Support for Elderly Persons Discharged from Public Hospitals after Treatment and are receiving services from community support services;
  • individuals with no mobility issues or who have limited mobility but can access the intervention sites using a wheelchair and are capable of practicing mindful yoga, even if in a wheelchair; and
  • individuals who can understand Cantonese.

Caregivers:

  • living with older adults during the transition period from hospital to home.

Exclusion criteria

Older adults discharged from hospital

  • older adults diagnosed with depression, anxiety, or stress disorders by certified doctors;
  • older adults diagnosed with severe dementia;
  • homebound older adults who face difficulty attending the intervention sites; and
  • older adults having a tech-enabled Hospital Admission Risk Reduction Program for the Elderly (HARRPE) score <0.17 or >0.29.

Caregivers:

  • Family caregivers who have been diagnosed with severe mental health issues will be excluded from the proposed study.

Treatment and study plan

Mindful yoga

Behavioral

12 week mindful yoga intervention

Psychoeducation

Behavioral

12 week psychoeducation sessions

Primary outcomes

  1. The Depression, Anxiety, and Stress Scale

    Time frame: Through study completion, an average of 12 weeks

    The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress

Secondary outcomes

  1. Five Facet Mindfulness Questionnaire

    Time frame: Through study completion, an average of 12 weeks

    The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness

  2. Five Facet Mindfulness Questionnaire

    Time frame: 3 months follow-up

    The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness

  3. Five Facet Mindfulness Questionnaire

    Time frame: 6 months follow-up

    The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness

  4. The meaning in life scale

    Time frame: Through study completion, an average of 12 weeks

    The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life

  5. The meaning in life scale

    Time frame: 3 months follow-up

    The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life

  6. The meaning in life scale

    Time frame: 6 months follow-up

    The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life

  7. The Depression, Anxiety, and Stress Scale

    Time frame: 3 months follow-up

    The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress

  8. The Depression, Anxiety, and Stress Scale

    Time frame: 6 months follow-up

    The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Wang

CONTACT

[email protected]

51610558

Xiaochen Zhou

CONTACT

[email protected]

26168617

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Examining the Effectiveness of Mindful Yoga in Enhancing Psychological Well-being Among Older Adults Discharged From Hospital and Their Caregivers: A Cluster Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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