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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Zentangle
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.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Sha Tin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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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