Clinical trial NCT04309279: Zentangle on Psychological Well-being
Official title: The Effects of Zentangle on Psychological Well-being Among Adults in Hong Kong: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Keywords: Zentangle
Mindful doodling
Mindfulness
Psychological Well-being
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization will be performed by an independent assessor using a computer-generated list of numbers. A 2-hour online Zentangle class will be delivered to the Zentangle group by a certified Zentangle teacher via online webinar. The Zentangle group will complete a short qualitative questionnaire and participate in a 15-minute brief discussion right after the Zentangle class. They will also be encouraged to practice Zentangle daily for two weeks. Both Zentangle group and waitlist control group will complete a set of online questionnaires before the intervention commences, immediately after the intervention and 2 weeks after the intervention. An online Zentangle class will be provided to the waitlist control group after the post-intervention data of the Zentangle group has been collected.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline (Pre-intervention), immediately after intervention and 2-week post-intervention
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scales-21 (DASS-21)
timeFrame: Baseline (Pre-intervention) and 2-week post-intervention
measure: Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF)
timeFrame: Baseline (Pre-intervention) and 2-week post-intervention
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline (Pre-intervention) and 2-week post-intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (Pre-intervention) and 2-week post-intervention
measure: Treatment evaluation form and engagement questionnaire
timeFrame: Immediately after intervention and 2-week post-intervention
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: