PsychologicalNCT06095037
Mindful Yoga for Older Adults and Caregivers
A study testing Mindful yoga and Psychoeducation in people with Psychological, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychological
- What is being tested?
- Mindful yoga and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
University of Hong Kong
Hong Kong
Xiaochen Zhou, 26168617, xczhou@hku.hk
Qi Wang, 51610558, vickywang@ln.edu.hk
About this study
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
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.
Read the 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.
- Conditions
- Psychological
- Being tested
- Mindful yoga, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful yogaBehavioural
12 week mindful yoga intervention
PsychoeducationBehavioural
12 week psychoeducation sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mindful yoga Receives: Behavioral: Mindful yoga |
| Control | Active comparator | Psychoeducation Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Depression, Anxiety, and Stress Scale
The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress
Measured: Through study completion, an average of 12 weeks
Secondary outcomes (8)
Five Facet Mindfulness Questionnaire
The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness
Measured: 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
Measured: 3 months follow-up
Five Facet Mindfulness Questionnaire
The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochen Zhou, The University of Hong Kong
- Investigators
- Qi Wang, Principal investigator, Lingnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095037
- Sponsor's protocol ID
- Mindfulyoga
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data without participants' privacy information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06095037
- Acronym / sponsor ID
- Mindfulyoga
- Conditions
- Psychological
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful yogaMindful yoga |
| Control | Active comparator | Behavioral: PsychoeducationPsychoeducation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful yoga12 week mindful yoga intervention | Behavioural | Intervention |
| Psychoeducation12 week psychoeducation sessions | Behavioural | Control |
Primary outcome
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
8 secondary outcomes
Five Facet Mindfulness Questionnaire
Time frame: Through study completion, an average of 12 weeks
Five Facet Mindfulness Questionnaire
Time frame: 3 months follow-up
Five Facet Mindfulness Questionnaire
Time frame: 6 months follow-up
The meaning in life scale
Time frame: Through study completion, an average of 12 weeks
The meaning in life scale
Time frame: 3 months follow-up
The meaning in life scale
Time frame: 6 months follow-up
The Depression, Anxiety, and Stress Scale
Time frame: 3 months follow-up
The Depression, Anxiety, and Stress Scale
Time frame: 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Yes. Data without participants' privacy information will be shared
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qi Wang principal investigator
Lingnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful yoga and Psychoeducation in people with Psychological, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Wang (51610558, vickywang@ln.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Depression, Anxiety, and Stress Scale (time frame: Through study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.