Mental Health Wellness Clinical Trial
Official title:
The Effects of Zentangle on Psychological Well-being Among Adults in Hong Kong: A Pilot Randomized Controlled Trial
NCT number | NCT04309279 |
Other study ID # | PSY011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 11, 2020 |
Est. completion date | July 30, 2020 |
Verified date | January 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | July 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Hong Kong residents 2. Aged from 18 to 65 3. Cantonese language fluency 4. Willingness to provide informed consent and comply with the trial protocol 5. Be able to join online webinar via a computer Exclusion Criteria: 1. Have suicidal ideation 2. Are using medication or psychotherapy for any psychiatric disorder 3. Experiencing depression and anxiety 4. Have major psychiatric, medical or neurocognitive disorders that make participation infeasible based on the research team's judgment 5. Are currently participating in a mindfulness practice |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Positive and Negative Affect Schedule (PANAS) | 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. | Baseline (Pre-intervention), immediately after intervention and 2-week post-intervention | |
Secondary | Change in Depression Anxiety Stress Scales-21 (DASS-21) | 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. | Baseline (Pre-intervention) and 2-week post-intervention | |
Secondary | Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) | 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. | Baseline (Pre-intervention) and 2-week post-intervention | |
Secondary | Self-Compassion Scale-Short Form (SCS-SF) | 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. | Baseline (Pre-intervention) and 2-week post-intervention | |
Secondary | Insomnia Severity Index (ISI) | 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. | Baseline (Pre-intervention) and 2-week post-intervention | |
Secondary | Treatment evaluation form and engagement questionnaire | 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. | Immediately after intervention and 2-week post-intervention |
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