Mindful Yoga for Older Adults and Caregivers

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychological
• Intervention / Treatment: Behavioral: Mindful yoga; Behavioral: Psychoeducation

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 Type: Interventional
• Enrollment (Estimated): 668
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Wang; Phone Number: 51610558; Email: vickywang@ln.edu.hk
• Study Contact Backup: Name: Xiaochen Zhou; Phone Number: 26168617; Email: xczhou@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong
    • Contact: Qi Wang; Phone Number: 51610558; Email: vickywang@ln.edu.hk
    • Contact: Xiaochen Zhou; Phone Number: 26168617; Email: xczhou@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Depression, Anxiety, and Stress Scale	The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress	Through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	Through study completion, an average of 12 weeks
Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	3 months follow-up
Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	6 months follow-up
The meaning in life scale	The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life	Through study completion, an average of 12 weeks
The meaning in life scale	The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life	3 months follow-up
The meaning in life scale	The total score ranges from 10 to 70. Higher scores indicates higher level of meaning in life	6 months follow-up
The Depression, Anxiety, and Stress Scale	The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress	3 months follow-up
The Depression, Anxiety, and Stress Scale	The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress	6 months follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Qi Wang, Lingnan University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Mindfulyoga

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data without participants' privacy information will be shared
• IPD Sharing Time Frame: The supporting documents will be shared June 30, 2024
• IPD Sharing Access Criteria: Anyone can access to the supporting documents
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No