Mindfulness-based Zentangle for Parents

Anxiety Clinical Trial

Official title:

Mindfulness-based Zentangle for Reducing Depression and Anxiety Symptoms in Parents: a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094803
• Other study ID #: HE-RD/2023/1.17
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Hong Kong Metropolitan University
• Contact: Grace Yuying Sun
• Phone: 852 39702916
• Email: gsun[@]hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The goal of this pilot randomized controlled trial 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. Participants will be instructed to attain the Zentangle courses, a Certified Zentangle Teacher (CZT) will deliver two 2-hour weekly group sessions. After completing the assessments, the waitlist control group will receive the same training sessions. The hypothesis is that the intervention group will show more significant decreases in depressive and anxiety symptoms, well-being improvement, less stress and better quality of life than the control group.

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 60 parents who have mild to moderate 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. Per-protocol sensitivity analyses will be conducted to analyse the outcomes in adherent participants who attend all the sessions and complete the questionnaires. It is expected that the intervention group show more significant improvements in the measured outcomes than the control group, indicating preliminary evidence of effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 59 Years

Eligibility

Inclusion Criteria:

1. 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;

2. report mild to moderate depressive symptoms (score of 5-14 on the Patient Health Questionnaire, PHQ-9) or anxiety (General Anxiety Disorder (GAD) - 7, score 5-14) during the screening;

3. Hong Kong residents who can speak Cantonese and read Chinese;

4. Individuals who have interests in participation and are able to communicate.

Exclusion Criteria:

1. under psychiatric treatment or taking antidepressants in the past six months;

2. respondents with PHQ or GAD score > 14 will be advised to consult a doctor.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Mindfulness-based Zentangle Program
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.

Locations

Country	Name	City	State
Hong Kong	Jockey Club Institute of Healthcare, Hong Kong Metropolitan University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall satisfaction with the program and subjective changes	Subjective changes including personal mental health, parent-child conflict, and parent-child communication. Participants will rate their overall satisfaction with the activity on a scale of 0 to 10, where "0" represents "very unsatisfied" and "10" represents "very satisfied". Open-ended questions will be used to gather comments and suggestions from the participants.	T2: Immediate post-intervention; T3: Three months after the intervention
Primary	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.	T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Primary	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.	T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Secondary	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.	T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Secondary	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.	T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention
Secondary	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.	T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention