Depressive SymptomsNCT06094803
Mindfulness-based Zentangle for Parents
A study testing Mindfulness-based Zentangle Program in people with Depressive Symptoms and Anxiety, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
Substantial evidence supports the effect of mindfulness practices on improving health outcomes. Zentangle is a mindfulness-based art therapy (MBAT) that combines art-making and meditation using simple materials. Read more about this study
- Who is it for?
- Ages 24 to 59 years
- Conditions the study is for
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- What is being tested?
- Mindfulness-based Zentangle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Oct 2023to 31 Aug 2024
- 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 24 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Parents with children in primary or secondary schools (Grade P1-6 and S1-6, 6-17 years old), being between 24 and 59 years old;
- Report mild to severe depressive symptoms (score of 5-27 on the Patient Health Questionnaire, PHQ-9) or anxiety (General Anxiety Disorder (GAD) - 7, score 5-21) during the screening. Respondents with PHQ or GAD score > 14 will be advised to consult a doctor.
- Hong Kong residents who can speak Cantonese and read Chinese;
- Individuals who have interests in participation and are able to communicate.
Who cannot join
- 1) under psychiatric treatment or taking antidepressants in the past six months;
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Jockey Club Institute of Healthcare, Hong Kong Metropolitan University
Hong Kong
About this study
Official title: Mindfulness-based Zentangle for Reducing Depression and Anxiety Symptoms in Parents: a Pilot Randomised Controlled Trial
Substantial evidence supports the effect of mindfulness practices on improving health outcomes. Zentangle is a mindfulness-based art therapy (MBAT) that combines art-making and meditation using simple materials. The goal of this pilot randomized controlled trial is to assess the effectiveness of mindfulness-based Zentangle interventions for reducing depression and anxiety symptoms and mindful parenting in parents with mild to severe depression or anxiety. Participants will be instructed to attain the Zentangle courses, a Certified Zentangle Teacher (CZT) will deliver two 2-hour weekly group sessions. At the end of the course, they will be invited to participate in an artwork show. After completing the assessments, the waitlist control group will receive the same training sessions and also be invited to the artwork show. The hypothesis is that the intervention group will show more significant decreases in depressive and anxiety symptoms, mental well-being and mindful parenting improvement, less stress and better quality of life than the control group.
Read the detailed description
Parents face day-to-day stress related to parenting and other stressors, such as low household income, child behavioural problems and high expectations for their children. Mindful parenting research is becoming popular in recent years, and substantial evidence supports the effect of mindfulness practices on improving health outcomes. The simplicity of Zentangle gives it the potential to cultivate and apply mindfulness practice in daily family life. Zentangle art is becoming popular in Hong Kong and in other countries and regions. However, there are limited exploratory trials to evaluate the effectiveness of Zentangle. Therefore, the aim of the present study is to assess the effectiveness of mindfulness-based Zentangle interventions for reducing depression and anxiety symptoms in parents with mild to moderate depression or anxiety.
A pilot randomised controlled trial (1:1 allocation ratio) on parents who have mild to severe depression or anxiety symptoms will be conducted. Participants will be approached through public posters or active approach in community centres, such as Caritas Community Centre. Interested individuals will scan the QR code on the poster and complete a short online questionnaire via Qualtrics. The research staff will contact the eligible respondents and send them a link for collecting the baseline questionnaire (T1). Randomisation will be conducted after obtaining consent and completion of T1. Participants will be randomised into the intervention or control groups using random numbers generated by a statistician not involved in any part of the study. The random numbers will be generated by Microsoft Excel. The recruitment staff will be concealed from the allocation process. The intervention group will receive two weekly sessions of training and complete the immediate post-intervention assessment (T2, two weeks after T1), and the 3-month assessment (T3, three months after T1). The waitlist control group will complete the assessments during the same time points and receive the training after completion of T3.
A Certified Zentangle Teacher (CZT) will deliver two 2-hour weekly group sessions to the intervention group. The content will include 1) an introduction to Zentangle, guide participants to set intentions of mindfulness, open mind, gratitude, and appreciation; 2) simple mindfulness practice in each session to cultivate mindfulness, such as body scan and sitting meditation; 3) step-by-step explanation and demonstration of examples of various patterns; 4) instruct participants to create their unique art; 5) interactive sharing of participants' artworks, experience and feelings during the workshop. After completing the assessments, the waitlist control group will receive the same training sessions. An art show will be organised afterwards. Parents will be invited to create one or two pieces of Zentangle artwork at home and submit them to the research team before the show.
The baseline characteristics of the two groups will be compared using an independent t-test and Chi-squared test. An intention-to-treat approach will be used and a multilevel mixed model will be built to calculate between-group mean differences in the outcomes after adjusting for the baseline values of the respective outcomes. The effect size (Cohen's d) will be calculated. Subgroup analyses will also be conducted based on the number of drawings actually performed by participants. Within-group mean differences will be compared by paired t-tests. Missing data were recognised as randomly missing and dealt with the multiple imputation method. A complete case analyses will performed as a sensitivity analysis. It is expected that the intervention group show more significant improvements in the measured outcomes than the control group, indicating preliminary evidence of effectiveness.
- Conditions
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- Being tested
- Mindfulness-based Zentangle Program
- Keywords
- Depressive Symptoms, Anxiety, Zentangle, Parents, Mindfulness-based
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Zentangle ProgramBehavioural
Session 1 focuses on "Self-awareness and Self-kindness" through the Zentangle method. It covers the introduction, basic techniques, and eight steps of Zentangle. Participants practice mindfulness and learn grid and round patterns. Drawing mindfully and interactive sharing are encouraged for engagement and reflection.
Session 2 emphasizes "Acceptance and Non-judgmental Attitude". It builds on the previous session, exploring advanced techniques in the Zentangle method. Participants practice mindfulness, learn organic and texturing patterns, create their own artwork, and engage in interactive sharing for reflection.
| Study group | Role | What they receive |
|---|---|---|
| Receiving Mindfulness-based Zentangle Interventions | Experimental | Participants in the intervention group will receive two 2-hour weekly sessions, focusing on two main themes, which are "Self-awareness and self-kindness" as well as "Acceptance and non-judgmental attitude". Each session with one hour duration and have five different contents separately. Receives: Behavioral: Mindfulness-based Zentangle Program |
| Waitlist Control Group | No intervention | The waitlist control group will not receive any training before all the assessments have been done by both groups. Yet, they will receive the same mindfulness-based Zenatngle training after the assessment period (3 months after baseline). They will be notified that their level of depressive and/or anxiety symptoms when the baseline assessment has been finished. Respondents with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder (GAD-7) score higher than 14 will be advised to consult a doctor, same as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ)-9. Participants will be asked to rate the frequency of nine symptoms experienced in the past two weeks on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating a higher severity of depressive symptoms.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Changes in Anxiety Symptoms
To assess anxiety disorder, the Generalized Anxiety Disorder (GAD)-7 scale will be adopted. Participants will rate the frequency of seven symptoms on a 4-point Likert scale (from 0=not at all to 3=nearly every day), using the same response options as the PHQ-9 scale. The total score on the GAD-7 ranges from 0 to 21, with a higher score indicating a greater level of anxiety.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Secondary outcomes (4)
Changes in Well-being
The Short Warwick-Edinburgh Mental Well-being Scale, consisting of seven items, will be utilized to assess well-being. Participants will use a 5-point Likert scale (1=none of the time, 5=all the time) to rate their experiences. The well-being score is determined by summing the responses to all seven items, resulting in a range of 7 to 35. A higher score indicates a greater level of well-being.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Changes in Perceived Psychological Stress
To assess psychological stress over the past month, the Chinese version of the Perceived Stress Scale-10 (PSS-10) will be employed. The scale comprises six positive and four negative items, with each item rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The positive items will be reverse scored before calculating the total score. Scores on the PSS-10 range from 0 to 40, with higher scores indicating a greater perceived psychological stress level.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Quality-adjusted Life Years (QALYs)
The 5-item EuroQol (EQ-5D-5L) will be used to measure the QALYs. The crosswalk value sets of Hong Kong will be used to convert EQ-5D-5L to the utility weight. The values ranged from -0.864 to 1. Each individual QALY was calculated by using the Area Under the Curve method.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Mindfulness in Parenting
To evaluate mindful parenting for parents with children or/and adolescents, ranging in age from 2 to 16 years old, the Chinese version of the Mindfulness in Parenting Questionnaire (MIPQ) will be used. Participants will use a 4-point Likert scale (1=sometimes, 4=all the time) to rate their experiences. The score is determined by summing the responses to all 28 items, resulting in a range of 28 to 112. A higher score indicates a higher level of mindful parenting.
Measured: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
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 start31 Oct 2023
- Primary completion24 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Grace SUN Yuying, Hong Kong Metropolitan University
- Investigators
- Yuying Sun, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094803
- Sponsor's protocol ID
- HE-RD/2023/1.17
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2023
- Last updated
- 15 Oct 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Zentangle for Reducing Depression and Anxiety Symptoms in Parents: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06094803
- Acronym / sponsor ID
- HE-RD/2023/1.17
- Conditions
- Depressive Symptoms, Anxiety, Well-Being, Psychological
- Keywords
- Depressive Symptoms, Anxiety, Zentangle, Parents, Mindfulness-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- 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.
Substantial evidence supports the effect of mindfulness practices on improving health outcomes. Zentangle is a mindfulness-based art therapy (MBAT) that combines art-making and meditation using simple materials. The goal of this pilot randomized controlled trial is to assess the effectiveness of mindfulness-based Zentangle interventions for reducing depression and anxiety symptoms and mindful parenting in parents with mild to severe depression or anxiety. Participants will be instructed to attain the Zentangle courses, a Certified Zentangle Teacher (CZT) will deliver two 2-hour weekly group sessions. At the end of the course, they will be invited to participate in an artwork show. After completing the assessments, the waitlist control group will receive the same training sessions and also be invited to the artwork show. The hypothesis is that the intervention group will show more significant decreases in depressive and anxiety symptoms, mental well-being and mindful parenting improvement, less stress and better quality of life than the control group.
Detailed description
Parents face day-to-day stress related to parenting and other stressors, such as low household income, child behavioural problems and high expectations for their children. Mindful parenting research is becoming popular in recent years, and substantial evidence supports the effect of mindfulness practices on improving health outcomes. The simplicity of Zentangle gives it the potential to cultivate and apply mindfulness practice in daily family life. Zentangle art is becoming popular in Hong Kong and in other countries and regions. However, there are limited exploratory trials to evaluate the effectiveness of Zentangle. Therefore, the aim of the present study is to assess the effectiveness of mindfulness-based Zentangle interventions for reducing depression and anxiety symptoms in parents with mild to moderate depression or anxiety.
A pilot randomised controlled trial (1:1 allocation ratio) on parents who have mild to severe depression or anxiety symptoms will be conducted. Participants will be approached through public posters or active approach in community centres, such as Caritas Community Centre. Interested individuals will scan the QR code on the poster and complete a short online questionnaire via Qualtrics. The research staff will contact the eligible respondents and send them a link for collecting the baseline questionnaire (T1). Randomisation will be conducted after obtaining consent and completion of T1. Participants will be randomised into the intervention or control groups using random numbers generated by a statistician not involved in any part of the study. The random numbers will be generated by Microsoft Excel. The recruitment staff will be concealed from the allocation process. The intervention group will receive two weekly sessions of training and complete the immediate post-intervention assessment (T2, two weeks after T1), and the 3-month assessment (T3, three months after T1). The waitlist control group will complete the assessments during the same time points and receive the training after completion of T3.
A Certified Zentangle Teacher (CZT) will deliver two 2-hour weekly group sessions to the intervention group. The content will include 1) an introduction to Zentangle, guide participants to set intentions of mindfulness, open mind, gratitude, and appreciation; 2) simple mindfulness practice in each session to cultivate mindfulness, such as body scan and sitting meditation; 3) step-by-step explanation and demonstration of examples of various patterns; 4) instruct participants to create their unique art; 5) interactive sharing of participants' artworks, experience and feelings during the workshop. After completing the assessments, the waitlist control group will receive the same training sessions. An art show will be organised afterwards. Parents will be invited to create one or two pieces of Zentangle artwork at home and submit them to the research team before the show.
The baseline characteristics of the two groups will be compared using an independent t-test and Chi-squared test. An intention-to-treat approach will be used and a multilevel mixed model will be built to calculate between-group mean differences in the outcomes after adjusting for the baseline values of the respective outcomes. The effect size (Cohen's d) will be calculated. Subgroup analyses will also be conducted based on the number of drawings actually performed by participants. Within-group mean differences will be compared by paired t-tests. Missing data were recognised as randomly missing and dealt with the multiple imputation method. A complete case analyses will performed as a sensitivity analysis. It is expected that the intervention group show more significant improvements in the measured outcomes than the control group, indicating preliminary evidence of effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving Mindfulness-based Zentangle Interventions | Experimental | Behavioral: Mindfulness-based Zentangle ProgramParticipants in the intervention group will receive two 2-hour weekly sessions, focusing on two main themes, which are "Self-awareness and self-kindness" as well as "Acceptance and non-judgmental attitude". Each session with one hour duration and have five different contents separately. |
| Waitlist Control Group | No intervention | –The waitlist control group will not receive any training before all the assessments have been done by both groups. Yet, they will receive the same mindfulness-based Zenatngle training after the assessment period (3 months after baseline). They will be notified that their level of depressive and/or anxiety symptoms when the baseline assessment has been finished. Respondents with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder (GAD-7) score higher than 14 will be advised to consult a doctor, same as the intervention group. |
Who may qualify
- Ages
- 24 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parents with children in primary or secondary schools (Grade P1-6 and S1-6, 6-17 years old), being between 24 and 59 years old;
- Report mild to severe depressive symptoms (score of 5-27 on the Patient Health Questionnaire, PHQ-9) or anxiety (General Anxiety Disorder (GAD) - 7, score 5-21) during the screening. Respondents with PHQ or GAD score > 14 will be advised to consult a doctor.
- Hong Kong residents who can speak Cantonese and read Chinese;
- Individuals who have interests in participation and are able to communicate.
Key exclusion criteria (1 listed)
- 1) under psychiatric treatment or taking antidepressants in the past six months;
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 |
|---|---|---|
| Mindfulness-based Zentangle ProgramSession 1 focuses on "Self-awareness and Self-kindness" through the Zentangle method. It covers the introduction, basic techniques, and eight steps of Zentangle. Participants practice mindfulness and learn grid and round patterns. Drawing mindfully and interactive sharing are encouraged for engagement and reflection. Session 2 emphasizes "Acceptance and Non-judgmental Attitude". It builds on the previous session, exploring advanced techniques in the Zentangle method. Participants practice mindfulness, learn organic and texturing patterns, create their own artwork, and engage in interactive sharing for reflection. | Behavioural | Receiving Mindfulness-based Zentangle Interventions |
Primary outcome
Changes in Depressive Symptoms
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ)-9. Participants will be asked to rate the frequency of nine symptoms experienced in the past two weeks on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating a higher severity of depressive symptoms.
Changes in Anxiety Symptoms
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
To assess anxiety disorder, the Generalized Anxiety Disorder (GAD)-7 scale will be adopted. Participants will rate the frequency of seven symptoms on a 4-point Likert scale (from 0=not at all to 3=nearly every day), using the same response options as the PHQ-9 scale. The total score on the GAD-7 ranges from 0 to 21, with a higher score indicating a greater level of anxiety.
4 secondary outcomes
Changes in Well-being
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Changes in Perceived Psychological Stress
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Quality-adjusted Life Years (QALYs)
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Mindfulness in Parenting
Time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
Yuying Sun principal investigator
Hong Kong Metropolitan 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 Mindfulness-based Zentangle Program in people with Depressive Symptoms and Anxiety, run by Hong Kong Metropolitan University 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 15 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Depressive Symptoms (time frame: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention). The study lists 2 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 15 Oct 2024.