MindfulnessNCT06595849
Acceptability, Feasibility, and Effectiveness of a Four-Week Feeling Tone Mindfulness Course
A study testing 4-week feeling tone intervention program in people with Mindfulness and Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Depression, Anxiety
- What is being tested?
- 4-week feeling tone intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 or above
- speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the course without the need for translation support
- have means to access online teleconferencing meeting software (e.g., Zoom), online surveys, online intervention materials, and Short Message Service (SMS) or WhatsApp messenger
Who cannot join
- moderately severe or severe depressive or anxiety symptoms
- diagnosed with bipolar disorder or bipolar affective disorder (type I or type II) or ever experienced a manic/hypomanic episode
- diagnosed with schizophrenia/ psychosis or ever experienced a psychotic episode
- diagnosed with dementia/ neurocognitive disorders/ neurological disorders
- diagnosed with intellectual disability
- diagnosed with other neurodevelopmental disorders
Show all 12Show fewer
- experience of a traumatic event that is currently affecting the potential participants
- recent bereavement, major loss, or stressful life events
- suicidal
- alcohol or drug abuse
- currently experiencing other mental or physical health condition, or life condition that might affect potential participants' participation in the course
- prior experience of taking part in the feeling tone intervention as a course participant
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Psychology, The University of Hong Kong
Hong Kong
About this study
This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes.
Read the detailed description
The four-week feeling tone mindfulness course is an adapted version of a mindfulness intervention program recently developed by Professor Mark Williams and colleagues. This study aims to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes (e.g., depression, anxiety, stress, wellbeing) in a Hong Kong population.
- Conditions
- Mindfulness, Depression, Anxiety, Stress, Wellbeing, Self-compassion
- Being tested
- 4-week feeling tone intervention program
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-week feeling tone intervention programBehavioural
Participants will take part in a 4-week mindfulness of feeling tone intervention program taught by a registered mindfulness teacher, who is also a registered clinical psychologist. The intervention program includes 4 sessions, with each session lasting for about 2 hours. The program is taught in Cantonese, in a group setting, live online (via Zoom). Participants will practice meditation practices during the session, explore themes of the week, review and explore their meditation experiences. They will also practice meditation practices daily for at least 30 minutes at home, with meditation audio recordings provided by the teacher.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a single-arm trial, where all participants will be assigned to the intervention group. Receives: Behavioral: 4-week feeling tone intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness (Five Facet Mindfulness Questionnaire - 20)
The 20-item Five Facet Mindfulness Questionnaire - 20 (FFMQ-20) will be used to measure mindfulness. Possible score range is 20 to 100, where higher scores indicate higher mindfulness.
Measured: 4-week; 8-week
Equanimity (Equanimity Scale)
The 16-item Equanimity Scale (ES-16) will be used to measure equanimity. Possible score range is 16 to 80, where higher scores indicate higher equanimity.
Measured: 4-week; 8-week
Self-compassion (Sussex-Oxford Compassion for the Self Scale)
The 20-item Sussex-Oxford Compassion for the Self Scale (SOCS-S) will be used to measure self-compassion. Possible score range is 20 to 100, where higher scores indicate higher self-compassion.
Measured: 4-week; 8-week
Secondary outcomes (4)
Depression (Patient Health Questionnaire - 9)
The nine-item Patient Health Questionnaire - 9 (PHQ-9) will be used to measure depression. Possible score range is 0 to 27, where higher scores mean more severe depression.
Measured: 4-week; 8-week
Anxiety (Generalized Anxiety Disorder - 7)
The seven-item Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Possible score range is 0 to 21, where higher scores indicate more severe anxiety.
Measured: 4-week; 8-week
Stress (Perceived Stress Scale - 10)
The 10-item Perceived Stress Scale - 10 (PSS) will be used to measure stress. Possible score range is 0 to 40, where higher scores indicate higher perceived stress.
Measured: 4-week; 8-week
Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale)
The seven-item Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) will be used to measure wellbeing. Possible score range is 0 to 35, where higher scores mean higher mental wellbeing.
Measured: 4-week; 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoi Chun Lok, MSocSc(CP), Principal investigator, Department of Psychology, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595849
- Sponsor's protocol ID
- 1005240113_Study2
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility, and Effectiveness of a Four-Week Feeling Tone Mindfulness Course
- ClinicalTrials.gov ID
- NCT06595849
- Acronym / sponsor ID
- 1005240113_Study2
- Conditions
- Mindfulness, Depression, Anxiety, Stress, Wellbeing, Self-compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (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 is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes.
Detailed description
The four-week feeling tone mindfulness course is an adapted version of a mindfulness intervention program recently developed by Professor Mark Williams and colleagues. This study aims to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes (e.g., depression, anxiety, stress, wellbeing) in a Hong Kong population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 4-week feeling tone intervention programThis is a single-arm trial, where all participants will be assigned to the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or above
- speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the course without the need for translation support
- have means to access online teleconferencing meeting software (e.g., Zoom), online surveys, online intervention materials, and Short Message Service (SMS) or WhatsApp messenger
Key exclusion criteria (12 listed)
- moderately severe or severe depressive or anxiety symptoms
- diagnosed with bipolar disorder or bipolar affective disorder (type I or type II) or ever experienced a manic/hypomanic episode
- diagnosed with schizophrenia/ psychosis or ever experienced a psychotic episode
- diagnosed with dementia/ neurocognitive disorders/ neurological disorders
- diagnosed with intellectual disability
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 |
|---|---|---|
| 4-week feeling tone intervention programParticipants will take part in a 4-week mindfulness of feeling tone intervention program taught by a registered mindfulness teacher, who is also a registered clinical psychologist. The intervention program includes 4 sessions, with each session lasting for about 2 hours. The program is taught in Cantonese, in a group setting, live online (via Zoom). Participants will practice meditation practices during the session, explore themes of the week, review and explore their meditation experiences. They will also practice meditation practices daily for at least 30 minutes at home, with meditation audio recordings provided by the teacher. | Behavioural | Intervention |
Primary outcome
Mindfulness (Five Facet Mindfulness Questionnaire - 20)
Time frame: 4-week; 8-week
The 20-item Five Facet Mindfulness Questionnaire - 20 (FFMQ-20) will be used to measure mindfulness. Possible score range is 20 to 100, where higher scores indicate higher mindfulness.
Equanimity (Equanimity Scale)
Time frame: 4-week; 8-week
The 16-item Equanimity Scale (ES-16) will be used to measure equanimity. Possible score range is 16 to 80, where higher scores indicate higher equanimity.
Self-compassion (Sussex-Oxford Compassion for the Self Scale)
Time frame: 4-week; 8-week
The 20-item Sussex-Oxford Compassion for the Self Scale (SOCS-S) will be used to measure self-compassion. Possible score range is 20 to 100, where higher scores indicate higher self-compassion.
4 secondary outcomes
Depression (Patient Health Questionnaire - 9)
Time frame: 4-week; 8-week
Anxiety (Generalized Anxiety Disorder - 7)
Time frame: 4-week; 8-week
Stress (Perceived Stress Scale - 10)
Time frame: 4-week; 8-week
Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale)
Time frame: 4-week; 8-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
Hoi Chun Lok, MSocSc(CP) principal investigator
Department of Psychology, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-week feeling tone intervention program in people with Mindfulness and Depression, 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoi Chun Lok, MSocSc(CP) (+852 3917-5889, hclok@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness (Five Facet Mindfulness Questionnaire - 20) (time frame: 4-week; 8-week). The study lists 3 primary outcomes in all. 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 19 Sep 2024.