- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235696
Game Intervention for Resilience
A Randomized Controlled Trial to Examine the Impact of a Game-based Intervention in Promoting Positive Affectivity and Enhancing Psychological Resilience
The goal of this clinical trial is to learn if a game-based intervention can enhance psychological resilience and promote positive affectivity in adults who have experienced major life stress.
The main questions it aims to answer are:
- Does the game-based intervention improve positive affectivity and mental health compared to a waitlist control group immediately after the intervention and at 3-month follow-up?
- Are the mental health benefits of the game-based intervention mediated by improvements in positive affectivity over time?
Researchers will compare the game-based intervention to an active control group and a waitlist control group to see if the game leads to better emotional and mental health outcomes.
Participants will:
- Be randomly assigned to the game-based intervention group, the psychoeducation intervention group (as active control group), or the waitlist control group
- Engage with the assigned program for 10 days within two weeks
- Complete psychological assessments before and after the intervention, and again at 3-month follow-up
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Associate Professor, Principle Investigator
- Phone Number: +852-3917-8927
- Email: rshao@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- fluency in oral and written Cantonese or Mandarin;
- having experienced at least one major life stress in the recent 5 years (assessed by the Life Stress Index);
- normal or corrected-to-normal vision and hearing.
Exclusion Criteria:
- formal diagnosis of any major psychiatric illnesses or history of suicidal behaviour;
- major physical illness, neurological condition or traumatic brain injury;
- Intake of medication within the previous 6 months that may affect emotion or cognitive functions;
- pregnancy (for women);
- prior experience with any commercial computer repair simulation game.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist control
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|
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Experimental: Game-based intervention
|
This intervention is a two-week game-based program designed to enhance psychological resilience and positive affectivity in individuals who have experienced major life stress.
The game incorporates emotionally engaging features such as reward mechanisms, adaptive challenge levels, and implicit emotion-regulation cues.
Unlike traditional psychoeducation or mindfulness-based interventions, this program uses interactive gameplay to target affective and cognitive processes associated with resilience.
|
|
Active Comparator: Psychoeducation intervention
|
The psychoeducation intervention will teach strategies to identify and regulate emotions, challenge negative thinking styles, improve mental flexibility, encourage optimism and active coping under adversity, and highlight the importance of self-value, life style and social support.
Participants will watch the psychoeducation materials for 1 hour/day, 5 days/week, 2 weeks in total.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Symptom-Checklist 90 (SCL-90) at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome assesses changes in participants' psychological symptoms using the Symptom-Checklist 90 (SCL-90), a validated self-report instrument that measures a broad range of psychological problems and symptoms of psychopathology.
Scores will be collected at baseline, immediately after the two-week intervention, and at 3-month follow-up to evaluate the effectiveness of the game-based intervention in improving mental health outcomes.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Positive Affect Assessed by Chinese Affect Scale (CAS) at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome assesses changes in positive affect using the positive affect subscale of the Chinese Affect Scale (CAS).
The measure will help determine whether the game-based intervention enhances emotional well-being.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
|
Change from Baseline in Positive Refocusing Strategy Measured by the Cognitive Emotion Regulation Questionnaire (CERQ) at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome evaluates changes in participants' use of positive refocusing as an emotion regulation strategy, measured by the corresponding subscale of the Cognitive Emotion Regulation Questionnaire (CERQ).
The measure captures the tendency to redirect attention toward positive aspects during stressful experiences.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
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Change from Baseline in Positive Reframing Strategy Measured by the Brief COPE at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome assesses changes in participants' use of positive reframing as a coping strategy, measured by the positive reframing subscale of the brief COPE inventory.
This subscale reflects the ability to reinterpret stressful situations in a more positive light.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
|
Change from Baseline in Mental Health Symptoms Assessed by Beck Depression Inventory-II (BDI-II) at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome assesses changes in participants' psychological symptoms using the Symptom-Checklist 90 (SCL-90), a validated self-report instrument that measures a broad range of psychological problems and symptoms of psychopathology.
Scores will be collected at baseline, immediately after the two-week intervention, and at 3-month follow-up to evaluate the effectiveness of the game-based intervention in improving mental health outcomes.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
|
Change from Baseline in Reward Processing Assessed by Monetary Incentive Delay (MID) Task at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
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This outcome evaluates participants' behavioral responses to reward anticipation and motivated actions using the Monetary Incentive Delay (MID) Task.
The task measures responses to reward, punishment, and neutral conditions, providing insight into the intervention's impact on reward-related brain function.
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Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
|
Change from Baseline in Cognitive Control Assessed by Color Stroop Task at Post-Assessment and 3-Month Follow-Up
Time Frame: Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
This outcome assesses participants' cognitive control and attentional regulation using the Color Stroop Task.
Reaction time and accuracy will be measured to evaluate changes in executive functioning following the intervention.
|
Baseline, Post-Intervention (2 weeks), and 3-Month Follow-Up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EA250229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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