Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-24 @ 5:07 AM
Study NCT ID:
NCT06175559
Status:
SUSPENDED
Last Update Posted:
2025-07-15
First Post:
2023-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012107', 'term': 'Research Design'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'We have finished the first-stage study.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-17', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': '10 minutes', 'description': 'Medication Adherence - Morisky Medication Adherence Scale-8 (MMAS-8): This scale assesses medication adherence through 8 items, providing a comprehensive evaluation of adherence.'}, {'measure': 'Medication Attitude', 'timeFrame': '10 minutes', 'description': "Medication Attitude - Drug Attitude Inventory (DAI) : This scale evaluates patients' attitudes toward medication, with higher scores indicating better attitudes."}], 'secondaryOutcomes': [{'measure': 'Game Experience', 'timeFrame': '10 minutes', 'description': "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."}, {'measure': 'Anxiety', 'timeFrame': '10 minutes', 'description': '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.'}, {'measure': 'Depression', 'timeFrame': '10 minutes', 'description': 'Depression - Patient Health Questionnaire-9 (PHQ-9): This scale assesses the severity of depressive symptoms, categorizing the level of depression from mild to severe.'}, {'measure': "Patients' Quality of Life", 'timeFrame': '10 minutes', 'description': '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.'}, {'measure': 'Social Functioning', 'timeFrame': '10 minutes', 'description': 'Social Disability Screening Schedule (SDSS): This scale assesses the degree of social disability, with higher scores indicating more severe social dysfunction.'}, {'measure': 'Clinical Symptoms', 'timeFrame': '10 minutes', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia and Related Disorders', 'Medication Adherence', 'Mental Health Issue', 'Gamification']}, 'referencesModule': {'references': [{'pmid': '40979217', 'type': 'DERIVED', 'citation': 'Liu Z, Zhu D, Zhang Z, Liu Y, Yang H, Chang F, Zhang W, Cai J. Effects of a narrative-based psychoeducational intervention on medication adherence in individuals with schizophrenia: a multicentre, parallel-group randomised controlled trial. EClinicalMedicine. 2025 Sep 4;88:103483. doi: 10.1016/j.eclinm.2025.103483. eCollection 2025 Oct.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nTo 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:\n\n1. 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.\n2. 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.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable Phase Schizophrenia\n* on long-term medication\n* medication adherence was problematic\n\nExclusion Criteria:\n\n* Serious Schizophrenia\n* Lack of basic cognitive abilities'}, 'identificationModule': {'nctId': 'NCT06175559', 'briefTitle': 'Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Embedded Narrative in Interactive Game Design for Improving Medication Adherence of Schizophrenia：Exploratory Research', 'orgStudyIdInfo': {'id': 'Sjtu0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healing Town: Embedded Narrative in Interactive Game Design', 'description': '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.', 'interventionNames': ['Combination Product: Healing Town: Embedded Narrative in Interactive Game (Psycho-education Tool) Design']}], 'interventions': [{'name': 'Healing Town: Embedded Narrative in Interactive Game (Psycho-education Tool) Design', 'type': 'COMBINATION_PRODUCT', 'description': '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', 'armGroupLabels': ['Healing Town: Embedded Narrative in Interactive Game Design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200240', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhao Liu, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the article is accepted', 'ipdSharing': 'YES', 'description': 'You can contact the author to obtain data, including patient medication adherence data before and after the experiment, interview data, and questionnaire data.', 'accessCriteria': 'zhudian@sjtu.edu.cn'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhu Dian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhu Dian', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}