NCT06094803

Brief 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 and mindful parenting in parents with mild to severe 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. At the end of the course, they will be invited to participate in an artwork show. After completing the assessments, the waitlist control group will receive the same training sessions and also be invited to the artwork show. The hypothesis is that the intervention group will show more significant decreases in depressive and anxiety symptoms, mental well-being and mindful parenting improvement, less stress and better quality of life than the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 16, 2023

Last Update Submit

October 10, 2024

Conditions

Keywords

Depressive SymptomsAnxietyZentangleParentsMindfulness-based

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • 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

Other Outcomes (1)

  • Overall satisfaction with the program and subjective changes

    T2: Immediate post-intervention; T3: Three months after the intervention

Study Arms (2)

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.

Behavioral: Mindfulness-based Zentangle Program

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.

Interventions

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.

Receiving Mindfulness-based Zentangle Interventions

Eligibility Criteria

Age24 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 severe depressive symptoms (score of 5-27 on the Patient Health Questionnaire, PHQ-9) or anxiety (General Anxiety Disorder (GAD) - 7, score 5-21) during the screening. Respondents with PHQ or GAD score \> 14 will be advised to consult a doctor.
  • Hong Kong residents who can speak Cantonese and read Chinese;
  • Individuals who have interests in participation and are able to communicate.

You may not qualify if:

  • \) under psychiatric treatment or taking antidepressants in the past six months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jockey Club Institute of Healthcare, Hong Kong Metropolitan University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Yuying Sun

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

October 31, 2023

Primary Completion

June 24, 2024

Study Completion

August 31, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations