Mindful Yoga for Older Adults and Caregivers

Psychological Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06095037
• Other study ID #: Mindfulyoga
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2025
• Est. completion date: September 1, 2028

Study information

• Verified date: October 2023
• Source: The University of Hong Kong
• Contact: Qi Wang
• Phone: 51610558
• Email: vickywang[@]ln.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 668
• Est. completion date: September 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychological

Intervention

Behavioral:
• Mindful yoga
12 week mindful yoga intervention
• Psychoeducation
12 week psychoeducation sessions

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	3 months follow-up
Secondary	Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	6 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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