- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06175559
Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia
Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia:Exploratory Research
Study Overview
Status
Conditions
Detailed Description
Our game design is inspired by Cognitive Behavioral Therapy (CBT), specifically the autonomic engagement and emotion regulation for the treatment of stable schizophrenic patients. This design aims to motivate patients to practice the basic principles of CBT in a virtual environment with the aim of producing positive psychological and behavioral changes in real life.
To ensure that the interactive design in the game can effectively promote cognitive reconstruction and emotional regulation in patients, the investigators used the following game interaction strategies:
- Situational simulation: By simulating real-life situations, patients face challenges and make decisions in the game that are similar to those in real life, so as to train their cognitive and emotional regulation.
- Immediate feedback: Provide patients with immediate feedback during the game so that they can understand the impact of their decisions on the outcome of the game, thus encouraging them to make more positive decisions in real life.
- Role-imitation: Encourage patients to take an in-depth look at their thoughts and behaviors from a third-person perspective by having them take on the role of a therapy practitioner.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200240
- Shanghai Jiao Tong University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stable Phase Schizophrenia
- on long-term medication
- medication adherence was problematic
Exclusion Criteria:
- Serious Schizophrenia
- Lack of basic cognitive abilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healing Town: Embedded Narrative in Interactive Game Design
The game-based medication intervention game "Wanping Town" in this study employed a multidisciplinary participatory design approach rooted in narrative theory and behavioral psychology models.
The game consists of two perspectives: narrative decision stories and cognitive games.
The investigators initially employed participatory design methods to determine the plot and elements within the game, then embedded the conclusions into the therapeutic elements of the game.
|
The narrative-based medication intervention game "Healing Town" in this study employed a multidisciplinary participatory design approach rooted in narrative theory and behavioral psychology models.
The game consists of two perspectives: narrative decision stories and cognitive games.
The investigators initially employed participatory design methods to determine the plot and elements within the game, then embedded the conclusions into the therapeutic elements of the game
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence
Time Frame: 10 minutes
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Medication Adherence - Morisky Medication Adherence Scale-8 (MMAS-8): This scale assesses medication adherence through 8 items, providing a comprehensive evaluation of adherence.
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10 minutes
|
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Medication Attitude
Time Frame: 10 minutes
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Medication Attitude - Drug Attitude Inventory (DAI) : This scale evaluates patients' attitudes toward medication, with higher scores indicating better attitudes.
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Game Experience
Time Frame: 10 minutes
|
the In-Game Core Scale (iGEQ): a standardized tool used to measure a player's experience while playing a video game.
It was developed by researchers to understand how players feel during gameplay, based on psychological and emotional factors.
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10 minutes
|
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Anxiety
Time Frame: 10 minutes
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Anxiety - Generalized Anxiety Disorder 7 (GAD-7) : This scale measures the level of anxiety in individuals, categorizing the severity into mild, moderate, and severe levels.
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10 minutes
|
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Depression
Time Frame: 10 minutes
|
Depression - Patient Health Questionnaire-9 (PHQ-9): This scale assesses the severity of depressive symptoms, categorizing the level of depression from mild to severe.
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10 minutes
|
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Patients' Quality of Life
Time Frame: 10 minutes
|
World Health Organization Quality of Life-BREF (WHOQOL-BREF) : This scale evaluates overall quality of life and health status, with a focus on physical, psychological, social, and environmental domains.
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10 minutes
|
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Social Functioning
Time Frame: 10 minutes
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Social Disability Screening Schedule (SDSS): This scale assesses the degree of social disability, with higher scores indicating more severe social dysfunction.
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10 minutes
|
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Clinical Symptoms
Time Frame: 10 minutes
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Clinical Symptoms - Brief Psychiatric Rating Scale (BPRS): This scale evaluates clinical symptoms across five factors, including anxiety-depression, lack of vitality, thought disturbances, activation, and hostile suspicion.
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10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zhao Liu, Prof, Shanghai Jiao Tong University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sjtu0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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