NCT06779357

Brief Summary

Background: Various studies have found that art-based workshops can reduce anxiety, stress and enhance positive emotion. Improving mental well-being plays an important role for people in the progress of recovery from mental illness. The Zentangle method and Pastel Nagomi Art promote relaxation by emphasizing no comparisons, critiques, or judgments of the finished piece with others, and appreciating the opportunity to make choices. However, there were limited studies examining the effectiveness of the artwork on people living in the community in the progress of recovery from mental illness. Purpose: To conduct a feasibility study to test the preliminary effects of Pastel Nagomi Art and Zentangle Art on mental health well-being among persons in recovery from mental illnesses. Methods: A 3-arm randomized control trial will be used: one arm with Zentangle workshops, the other arm with Pastel Nagomi Art, while the control group will receive usual care. Data collection from each participant will be conducted at 3-time points, at baseline (T0) before the 4-week weekly Pastel Nagomi Art or Zentangle Art program, right after the program (T1), and one month after the program (T2). The Statistical Software Package for Social sciences will be used for quantitative data analysis. All participants from each artwork group will be invited to partake 45-60 minutes focus group interview to share their experience with this intervention. The content of the focus group interview will be audio recorded. The audio recordings were transcribed verbatim in Chinese and imported into NVivo Pro 12 for data management. The qualitative data will be analyzed by using thematic content analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 30, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

October 2, 2024

Last Update Submit

March 19, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    The recruitment rate will be calculated by the number of participants recruited over the total number of participants approached

    8 weeks

  • Consent rate

    The consent rate will be calculated with number of participants signed the consent form over the total number of participants indicated they would participate in the study the interventions, arrangement, and the effect of the artworks on the study outcomes

    8 weeks

  • Attrition rate

    The attrition rate will be calculated with number of participants dropped out from the study over the total number of participants enrolled in the study

    8 weeks

Secondary Outcomes (8)

  • Teh Depression Anxiety Stress Scale illnesses.

    8 weeks

  • The Rosenberg Self-Esteem SCale

    8 weeks

  • The General Self-Efficacy Scale

    8 weeks

  • The Positive and Negative Affect Scale

    8 weeks

  • The revised Cognitive and Affective Mindfulness Scale

    8 weeks

  • +3 more secondary outcomes

Study Arms (3)

Pastel Nagomi Art Group

EXPERIMENTAL

Four face-to-face sessions of Pastel Nagomi Art will be held weekly at the Hong Kong Polytechnic University or Community Psychiatric Nursing Service centres at the convenience of the participants. Each session will last for about 120 minutes for a group size of 10-15 participants. Depending on the progress of the participants, one or two Pastel Nagomi Arts will be produced. At the end of the 10 minutes of each session, the particpants will show their products with sharing to one another.

Other: Artwork

Zentangle Group

EXPERIMENTAL

Four face-to-face sessions of Zentangle method will be held weekly at the Hong Kong Polytechnic University or Community Psychiatric Nursing Service centres at the convenience of the participants. Each session will last for about 120 minutes for a group size of 10-15 participants. Depending on the progress of the participants, one or two Zentangle arts will be produced. At the end of the 10 minutes of each session, the participants will show their products with sharing to one another.

Other: Artwork

Control Group

NO INTERVENTION

The control group with the size of 10-15 participants will receive usual care, that is, the care provided by the Community Psychiatric Nursing Service (CPNS).

Interventions

ArtworkOTHER

d. A 3-arm randomized control trial will be used: one arm with Zentangle workshops, the other arm with Pastel Nagomi Art, while the control group will receive usual care. Data collection from each participant will be conducted at 3-time points, at baseline (T0) before the 4-week weekly Pastel Nagomi Art or Zentangle Art program, right after the program (T1), and one month after the program (T2).

Pastel Nagomi Art GroupZentangle Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Service users of the Community Psychiatric Services of Kowloon West Cluster
  • had previously been clinically diagnosed with depression, anxiety or bipolar disorder

You may not qualify if:

  • The individuals who cannot speak and understand Chinese,
  • currently diagnosed with psychotic symptoms, and
  • currently taking or took Zentangle or pastel Nagomi art before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing

Hong Kong, Hong Kong

Location

Study Officials

  • Kin Cheung, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2024

First Posted

January 16, 2025

Study Start

September 30, 2023

Primary Completion

March 15, 2025

Study Completion

March 19, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations