- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309279
Zentangle on Psychological Well-being
January 14, 2021 updated by: Fiona YY Ho, Chinese University of Hong Kong
The Effects of Zentangle on Psychological Well-being Among Adults in Hong Kong: A Pilot Randomized Controlled Trial
This study will examine the effects of Zentangle as an intervention for reducing stress and enhancing psychological wellbeing among Hong Kong adults.
Zentangle is a mindful doodling process in which participants draw repetitive, structured patterns on small pieces of paper.
The patterns consist of combinations of dots, lines, and curves.
Zentangle is developed in 2003 by two Americans, and this concept is still new to many people.
Some studies suggested that Zentangle can be effective in reducing stress and anxiety, but the number of research papers on Zentangle is limited.
Although Zentangle has become a rather popular stress relief activity in Hong Kong recently due to its easiness to learn and minimal tool requirement, there is no related study on its effectiveness in promoting psychological wellbeing in Hong Kong.
Study Overview
Detailed Description
This study will be a pilot randomized controlled trial on the effects of Zentangle as an intervention for reducing stress and enhancing psychological wellbeing among Hong Kong adults.
Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants.
Around 30 eligible participants will be randomly assigned to either the Zentangle group or the waitlist control group in a ratio of 1:1.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sha Tin, Hong Kong
- The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hong Kong residents
- Aged from 18 to 65
- Cantonese language fluency
- Willingness to provide informed consent and comply with the trial protocol
- Be able to join online webinar via a computer
Exclusion Criteria:
- Have suicidal ideation
- Are using medication or psychotherapy for any psychiatric disorder
- Experiencing depression and anxiety
- Have major psychiatric, medical or neurocognitive disorders that make participation infeasible based on the research team's judgment
- Are currently participating in a mindfulness practice
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zentangle group
|
Zentangle is a mindful doodling process in which participants draw repetitive, structured patterns on small pieces of paper.
The patterns consist of combinations of dots, lines, and curves.
Other Names:
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No Intervention: Wait-list Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline (Pre-intervention), immediately after intervention and 2-week post-intervention
|
PANAS is a 20-item scale, comprises of two 10-item subscales measuring positive affect (PA) and negative affect (NA).
This self-report measure is being widely used in both clinical and community settings.
A 5-point Likert scale is employed, ranging from "very slightly or not at all" to "extremely", to measure the extent to which participants have experienced such feelings over a specific period of time.
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Baseline (Pre-intervention), immediately after intervention and 2-week post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Anxiety Stress Scales-21 (DASS-21)
Time Frame: Baseline (Pre-intervention) and 2-week post-intervention
|
DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress.
The DASS is based on a dimensional rather than a categorical conception of psychological disorder; thus, it has no direct implications for the allocation of patients to discrete diagnostic categories.
However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
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Baseline (Pre-intervention) and 2-week post-intervention
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Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF)
Time Frame: Baseline (Pre-intervention) and 2-week post-intervention
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The FFMQ-SF is a 24-item scale that is used to evaluate one's dispositional tendency to be mindful in daily life.
Ratings on the 5-point Likert scale are obtained on 5 factors, including acting with awareness, describing, nonjudging, nonreactivity and observing.
The 5-point scale ranging from "never or rarely true" to "very often or always true" is used to rate how frequent the participants had each experience.
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Baseline (Pre-intervention) and 2-week post-intervention
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Self-Compassion Scale-Short Form (SCS-SF)
Time Frame: Baseline (Pre-intervention) and 2-week post-intervention
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SCS-SF is a 12-item scale to evaluates the degree of self-compassion.
Ratings on the 5-point Likert scale are obtained on 6 factors, including self-kindness, common humanity, mindfulness, selfjudgment, isolation and over-identification.
The self-report 12-item SCS-SF explicitly represents the thoughts, emotions, and behaviors associated with self-compassion and includes items that measure how often people respond to feelings of inadequacy or suffering with each of six components.
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Baseline (Pre-intervention) and 2-week post-intervention
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Insomnia Severity Index (ISI)
Time Frame: Baseline (Pre-intervention) and 2-week post-intervention
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ISI is a 7-item scale designed to evaluate perceived insomnia severity.
Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
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Baseline (Pre-intervention) and 2-week post-intervention
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Treatment evaluation form and engagement questionnaire
Time Frame: Immediately after intervention and 2-week post-intervention
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Treatment evaluation form and engagement questionnaire will be used to collect participants' view on the Zentangle class and how often they practiced Zentangle for the past 2 weeks respectively.
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Immediately after intervention and 2-week post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2020
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
March 9, 2020
First Submitted That Met QC Criteria
March 12, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PSY011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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