Mindful Yoga for Older Adults and Caregivers

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06095037
Collaborator
(none)
668
1
2
42.1
15.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful yoga
  • Behavioral: Psychoeducation
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
668 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official 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
Anticipated Study Start Date :
Mar 1, 2025
Anticipated Primary Completion Date :
Mar 1, 2028
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Mindful yoga

Behavioral: Mindful yoga
12 week mindful yoga intervention

Active Comparator: Control

Psychoeducation

Behavioral: Psychoeducation
12 week psychoeducation sessions

Outcome Measures

Primary Outcome Measures

  1. The Depression, Anxiety, and Stress Scale [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 Outcome Measures

  1. Five Facet Mindfulness Questionnaire [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 [3 months follow-up]

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

  3. Five Facet Mindfulness Questionnaire [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 [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 [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 [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 [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 [6 months follow-up]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Qi Wang, Lingnan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaochen Zhou, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06095037
Other Study ID Numbers:
  • Mindfulyoga
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2023