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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05637190
Other study ID # PSY025
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Chinese University of Hong Kong
Contact Yeuk Yu Yip
Phone 3943 6575
Email pmhlab@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this pilot randomized controlled trial is to evaluate the effects of Expressive Art Therapy on reducing burnout and stress symptoms among Hong Kong's primary and secondary school teachers. The proposed study is a pilot randomized controlled trial. Prior to all study procedures, 90 participants (i.e., primary and secondary school teachers) will be recruited to complete an online informed consent with telephone support. Eligible participants will be randomly assigned to either the Expressive Arts Therapy group (ExAT group) or the waitlist control group (WL group) in a ratio of 1:1. The ExAT group will receive the Expressive Arts intervention via face-to-face workshops for 2 consecutive weeks (2 hours per session). There are a total of 3 batches (around 15 participants per batch) for the intervention. Participants in this group will be in touch with their inner selves and inner resources via body movement, writing and music. There will be visual art creation as a conclusion for integrating the body and mind. The art products would be placed in their workplace for stress regulation. The WL control group will not receive any intervention during the study, but they will receive self-help art therapy materials after the whole study procedure. The outcome measures include burnout, stress, depressive, and anxiety symptoms, as well as insomnia symptoms, physical activity, health-related quality of life, and the intervention acceptability at baseline, immediate post-treatment, and 4-week follow-up assessments by completing the same questionnaire set.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Hong Kong residents aged >/=18 2. Able to read Chinese (verbal expression in Chinese or English) 3. With qualified teaching cert. (degree holder) 4. Willing to provide informed consent and comply with the trial protocol 5. Teacher work in primary or secondary school in Hong Kong Exclusion Criteria: 1. Current involvement in psychological treatment program for stress and / or burnout reduction 2. A change in psychotropic drugs or over-the-counter medications that target mood within 2 weeks before the baseline assessment 3. A Patient Health Questionnair-9 (PHQ-9) item 9 score > 2 indicating a serious level of suicidal risk

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Expressive Arts Therapy group intervention
Art is helpful to reduce negative emotions and boost self-worth during the creative process. During the Expressive Arts Therapy workshops, participants experience different art forms, including visual art, body movement, writing, music, and guided imagery to identify the inner self and get in touch with the self to release suppressed emotions and stress.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Shirom-Melamed Burnout Measure (SMBM) A 14-item questionnaire with 7-point scale will be used for physical fatigue, emotion exhaustion, and cognitive weariness. The score ranges from 1(never or almost never) to 7 (always or almost always). Item 1-5: physical fatigue; item 6-8: emotional exhaustion; and item 9-14: cognitive wariness baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Primary Change in Perceived Stress Scale (PSS) A 10-item questionnaire measuring the perceived degree of stress across situations over the past month. Items include how unpredictable, uncontrollable, and overloaded do the respondents perceive. the score ranges from 0 (never) to 4 (very often) baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in The Patient Health Questionnaire (PHQ-9) A 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression, which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day) baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in The Generalized Anxiety disorder 7-item Scale (GAD-7) A brief 7-item instrument for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Anxiety severity is categorized using scores of 5-9 (mild), 10-14 (moderate) and 15or more (severe) baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in Insomnia Severity Index (ISI) A 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem and level of distress caused by the sleep problem. baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in Multidimensional Fatigue Inventory (MFI-20) A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert sscale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D) A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state) baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in Credibility-Expectancy questionnaire (CEQ) The 6-item CEQ yielded ratings of treatement credibility, acceptability/satisfaction, and expectations for success baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
Secondary Change in Treatment Acceptability and Adherence Scale (TAAS) A 10-item self-report scale designed to measure treatment acceptability on various facets, such as dropout likelihood and treatment adherence. baseline (week 0), immediate post intervention (week 3) and 4-week post intervention follow up
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