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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06175559
Other study ID # Sjtu0002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study explores the potential of an interactive narrative game to enhance medication adherence among stable schizophrenia patients. Employing participatory design methods, game's development and testing process actively involved patients and individuals closely connected to their daily lives. Artificial Intelligence-Generated Content (AIGC) facilitated swift iterations in game's visual style and content. During game therapy, patients are tasked with making decisions based on presented situations, which influence the course of the narrative.


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: 1. 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. 2. 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. 3. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date July 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Stable Phase Schizophrenia - on long-term medication - medication adherence was problematic Exclusion Criteria: - Serious Schizophrenia - Lack of basic cognitive abilities

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
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

Locations

Country Name City State
China Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Zhu Dian

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 8-item Morisky Medication Adherence Scale , MMAS-8 The MMAS-8 scale is a comprehensive but concise scale that covers multiple dimensions, including participants' understanding of medication, self-management skills, and compliance behavior during treatment. The items have been carefully designed to reveal the difficulties and challenges that patients may face during treatment from different perspectives, and help to fully characterize the dynamics of their adherence behavior. 10 minutes
Primary the In-Game Core Scale (iGEQ) This questionnaire covers 7 dimensions: immersion, fluency, challenge, positive emotions, negative emotions, uneasiness/irritability, and competence dimensions. 10 minutes
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