Anxiety, Mental Health
Conditions
Brief summary
The goal of this clinical trial is to learn if improv comedy helps reduce anxiety symptoms and improve mental well-being in Chinese young adults in Hong Kong. The main questions it aims to answer are: 1. Does improv comedy reduce anxiety symptoms? 2. Does improv comedy improve mental well-being? Researchers will compare participants who join the improv comedy workshops to participants who are placed on a waiting list to receive the workshops later, to see if improv comedy reduces anxiety and improves mental well-being. Participants will: 1. Attend weekly three-hour improv comedy workshops for 4 consecutive weeks 2. Complete four assessments and brief reflections during or around the workshop sessions 3. Take part in up to two individual interviews (optional)
Interventions
BEHAVIORALImprov Against Anxiety (IAA)
Improv Against Anxiety (IAA) is a structured, group-based improv comedy program consisting of four weekly 3-hour sessions. Sessions use established improv games and exercises to reduce anxiety symptoms and enhance mental well-bein
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Ethnic Chinese, fluent in spoken Mandarin and able to read Chinese * Never married and without children * No current or past diagnosis of any mental disorder (e.g. anxiety disorders, depressive disorders, bipolar disorder, psychotic disorders) * Mild to moderate anxiety symptoms (defined as a GAD-7 total score between 5 and 14) * No prior experience of formal performance training in drama * Availability to attend at least 3 out of 4 weekly sessions over the 4-week intervention period upon enrolment
Exclusion criteria
* Unstable or severe chronic physical illness that would contraindicate participation in group activities or light-to-moderate physical movement (e.g., uncontrolled hypertension, severe asthma, acute cardiovascular events within the past 6 months) * Moderately severe to severe depression symptoms (defined as a PHQ-9 total score greater than 14) * Suicidal ideation (defined as a score greater than 0 on item 9 of the PHQ-9) * Potential risky drinking behavior (defined as AUDIT-C total score greater than 4)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in mental well-being measured by the WHO-5 at Week 2, Week 4, and Week 6 | Baseline (pre-intervention), Week 2 (mid-treatment), Week 4 (post-intervention), and Week 6 (2-week follow-up) | The World Health Organization-Five Well-Being Index (WHO-5) ranges from 0 to 25, with higher scores indicating better mental well-being. |
| Mean change from baseline in anxiety symptoms measured by the GAD-7 at Week 2, Week 4, and Week 6 | Baseline (pre-intervention), Week 2 (mid-treatment), Week 4 (post-intervention), and Week 6 (2-week follow-up) | The Generalized Anxiety Disorder 7-Item Scale (GAD-7) ranges from 0 to 21, with higher scores indicating greater anxiety symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in depression symptoms measured by the PHQ-9 at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Patient Health Questionnaire-9 (PHQ-9) ranges from 0 to 27, with higher scores indicating greater depression symptoms. |
| Mean change from baseline in worry measured by the PSWQ-A at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Penn State Worry Questionnaire - Abbreviated (PSWQ-A) ranges from 8 to 40, with higher scores indicating greater worry. |
| Mean changes from baseline in positive and negative affect measured by the I-PANAS-SF at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) consists of five items measuring positive affect and five items measuring negative affect. Each subscale ranges from 5 to 25, with higher scores indicating a stronger presence of that specific affect. |
| Mean change from baseline in loneliness measured by the ULS-6 at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The 6-item UCLA Loneliness Scale (ULS-6) ranges from 6 to 24, with higher scores indicating greater loneliness. |
| Mean change from baseline in self-esteem measured by the RSES at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Rosenberg Self-Esteem Scale (RSES) ranges from 10 to 40, with higher scores indicating higher self-esteem. |
| Mean change from baseline in intolerance of uncertainty measured by the IUS-12 at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The 12-item Intolerance of Uncertainty Scale (IUS-12) consists of two subscales: prospective intolerance of uncertainty (items 1-7; range 7-35) and inhibitory intolerance of uncertainty (items 8-12; range 5-25). Higher scores on each subscale indicate greater intolerance of uncertainty in that domain. |
| Mean change from baseline in maximization tendency measured by the MTS-7 at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The 7-item Maximizing Tendency Scale (MTS-7) ranges from 7 to 35, with higher scores indicating a greater tendency to choose the best option. |
| Mean change from baseline in fear of negative evaluation measured by the BFNE-S at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Brief Fear of Negative Evaluation Scale-Straightforward Version (BFNE-S) ranges from 8 to 40, with higher scores indicating a higher level of fear of negative evaluation. |
| Mean change from baseline in playfulness measured by the APTS-CN at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Adult Playfulness Trait Scale-Chinese Version (APTS-CN) consists of three subscales: fun-seeking motivation (nine items; range 9-45), uninhibitedness (five items; range 5-25), and spontaneity (five items; range 5-25). Higher scores on each subscale indicate greater playfulness in that domain. |
| Mean change from baseline in openness to experience measured by the CBF-PI-B at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Chinese Big Five Personality inventory brief version (CBF-PI-B) ranges from 8 to 48, with higher scores indicating greater openness to experience. |
| Mean change from baseline in fantastic reality ability measured by the FRAME-SF at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Fantastic Reality Ability Measurement-Short Form (FRAME-SF) consists of four subscales: coping (four items; range 4-28), control (two items; range 2-14), transcendence (four items; range 4-28), and playfulness (three items; range 3-21). Higher scores on each subscale indicate greater fantastic reality ability in that domain. |
| Within-session change in state anxiety across four intervention sessions measured by the VAS-A | Immediately before and immediately after each weekly intervention, at Weeks 1, 2, 3, and 4. | State anxiety will be assessed at the start and end of each intervention session using a single-item anxiety visual analog scale (VAS-A), a continuous line from 0 ("not at all anxious") to 100 ("extremely anxious"), with higher scores reflecting greater state anxiety. The outcome will be defined as the mean pre- to post-session change in VAS-A scores across the four sessions. |
| Mean change from baseline in sleep disturbance measured by the ISI at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Insomnia Severity Index (ISI) ranges from 0 to 28, with higher scores indicating greater sleep disturbance. |
| Change in perceived group entitativity across four intervention sessions measured by the GEM-GP | Immediately after each weekly intervention, at Weeks 1, 2, 3, and 4. | The Group Entitativity Measure-Group Psychotherapy (GEM-GP) is a single-item, pictorial visual analog measure. It presents six configurations of circles that progressively move closer together. The central circle represents the respondent, and the surrounding four circles represent the other group members. Across the six images, the circles become increasingly close, illustrating a stronger sense of the group as a cohesive, unified entity. Participants select the configuration that best reflects how they currently experience the group; configurations with closer circles indicate higher perceived group entitativity. |
| Mean change from baseline in perceived stress measured by the PSS-4 at Week 2, Week 4, and Week 6 | Baseline (pre intervention), Week 2 (mid treatment), Week 4 (post intervention), and Week 6 (2 week follow up) | The Perceived Stress Scale-4 (PSS-4) ranges from 0 to 16, with higher scores indicating greater perceived stress. |
Countries
Hong Kong
Contacts
CONTACTHaorui Li
Outcome results
None listed