跳至主要内容
临床试验/NCT06094803
NCT06094803已完成不适用

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

Hong Kong Metropolitan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes in Anxiety Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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;
  • 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;
  • Hong Kong residents who can speak Cantonese and read Chinese;
  • Individuals who have interests in participation and are able to communicate.

排除标准

  • under psychiatric treatment or taking antidepressants in the past six months;
  • respondents with PHQ or GAD score > 14 will be advised to consult a doctor.

研究组 & 干预措施

Waitlist Control Group

No Intervention

The waitlist control group will not receive any training before all the assessments have been done by both groups. Yet, they will receive the same mindfulness-based Zenatngle training after the assessment period (3 months after baseline). They will be notified that their level of depressive and/or anxiety symptoms when the baseline assessment has been finished. Respondents with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder (GAD-7) score higher than 14 will be advised to consult a doctor, same as the intervention group.

Receiving Mindfulness-based Zentangle Interventions

Experimental

Participants in the intervention group will receive two 2-hour weekly sessions, focusing on two main themes, which are "Self-awareness and self-kindness" as well as "Acceptance and non-judgmental attitude". Each session with one hour duration and have five different contents separately.

干预措施: Mindfulness-based Zentangle Program (Behavioral)

结局指标

主要结局

Changes in Anxiety Symptoms

时间窗: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention

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.

Changes in Depressive Symptoms

时间窗: T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention

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.

次要结局

  • Changes in Well-being(T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention)
  • Changes in Perceived Psychological Stress(T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention)
  • Quality-adjusted Life Years (QALYs)(T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention)
  • Mindfulness in Parenting(T1: Baseline; T2: Immediate post-intervention; T3: Three months after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Grace SUN Yuying

Assistant Professor

Hong Kong Metropolitan University

研究点 (1)

Loading locations...

相似试验

Mindfulness-based Zentangle for Parents | 临床试验