Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-28 @ 9:59 PM
Study NCT ID:
NCT04586868
Status:
UNKNOWN
Last Update Posted:
2023-05-01
First Post:
2020-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR-assisted CBT for Adolescents With Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Level of functioning', 'timeFrame': '1 week after treatment.', 'description': "Children's Global Assessment Scale (C-GAS)"}], 'primaryOutcomes': [{'measure': 'Acceptability for a virtual reality intervention', 'timeFrame': '5 months', 'description': 'Semi-structured interview'}, {'measure': 'Social self-efficacy', 'timeFrame': '1 week before, and 10 minutes after treatment.', 'description': 'Adolescent self-efficacy scale (S-EFF)'}, {'measure': 'Social interaction and social phobia', 'timeFrame': '1 week before, and 10 minutes after treatment.', 'description': 'Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)'}, {'measure': 'Social paranoia', 'timeFrame': '1 week before and 1 week after treatment.', 'description': 'State Social Paranoia Scale (SSPS)'}], 'secondaryOutcomes': [{'measure': 'Self-esteem', 'timeFrame': '1 week before, and 10 minutes after treatment.', 'description': 'Rosenberg Self-Esteem scale (RSES)'}, {'measure': 'Psychotic symptoms', 'timeFrame': '1 week before and 1 week after treatment.', 'description': 'Brief Psychiatric Rating Scale (BPRS)'}, {'measure': 'The experience of presence', 'timeFrame': '10 minutes after treatment', 'description': 'Gatineau Presence Questionnaire (GPQ)'}, {'measure': 'Unwanted side effect', 'timeFrame': '10 minutes before and 10 minutes after treatment', 'description': 'Virtual Reality Sickness Questionnaire (VRSQ)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Adolescents', 'Virtual Reality treatment', 'Cognitive Behavioural Therapy', 'Early onset psychosis', 'VR-assisted therapy'], 'conditions': ['Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '35708166', 'type': 'DERIVED', 'citation': 'Holgersen G, Nordgreen T, Ten Velden Hegelstad W, Bircow Elgen I. Views of young people with psychosis on using virtual reality assisted therapy. A qualitative study. Early Interv Psychiatry. 2023 Apr;17(4):361-367. doi: 10.1111/eip.13331. Epub 2022 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'Psychotic disorders typically emerge during late adolescence or early adulthood. Patients, who are diagnosed with a psychotic disorder before turning 18 years, are defined as early onset psychosis patients (EOP). Relative to adult patients, these patients show a worse long-term prognoses. Social impairment present a major barrier towards recovery, and thus and important issue to address in treatment. Cognitive behavioral therapy (CBT) is the recommended psychological treatment for psychotic disorders. As part of the therapy, the patient does an exposure-based training in a social environment. This type of training has several limitations for patients with psychosis. The last decade there has been a growing interest in using virtual reality (VR) to understand and treat various psychological disorders. There is a lack of research on VR-interventions for EOP patients. This study will assess the acceptability, tolerability, feasibility and clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis.', 'detailedDescription': 'This study adhere to the model for research made by the international Virtual Reality Clinical Outcomes Research Experts groups (VR-CORE). The study consist of three sub-studies. First a qualitative study assessing the acceptability for VR among adolescence with psychosis. Secondly, a randomized study of the feasibility of virtual reality environment for adolescents with psychosis. Third, assessing the clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis, through a non-randomized single-case study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffering from a psychotic disorder (ICD-10 WHO)\n* In stable clinical condition (i.e. not hospitalized)\n* Being able to speak Norwegian or a Scandinavian language, or English\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Primary neurological or endocrinological disorder\n* Started a "transfer-process" to Department of Adult Psychiatry.'}, 'identificationModule': {'nctId': 'NCT04586868', 'briefTitle': 'VR-assisted CBT for Adolescents With Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis', 'orgStudyIdInfo': {'id': '95428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A psychotic disorder', 'description': 'Patients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 )', 'interventionNames': ['Behavioral: An intervention development study', 'Behavioral: A randomized feasibility study', 'Behavioral: A single-case study']}], 'interventions': [{'name': 'An intervention development study', 'type': 'BEHAVIORAL', 'description': 'Assessing the acceptability for a virtual reality intervention among adolescents with psychosis', 'armGroupLabels': ['A psychotic disorder']}, {'name': 'A randomized feasibility study', 'type': 'BEHAVIORAL', 'description': 'Feasibility of virtual reality environment for adolescents with psychosis', 'armGroupLabels': ['A psychotic disorder']}, {'name': 'A single-case study', 'type': 'BEHAVIORAL', 'description': 'The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis', 'armGroupLabels': ['A psychotic disorder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Irene Elgen, phd', 'role': 'CONTACT', 'email': 'irene.bircow.elgen@helse-bergen.no', 'phone': '004791550904'}, {'name': 'Anita Barsnes, MA', 'role': 'CONTACT', 'email': 'anita.barsnes@helse-bergen.no', 'phone': '004790922186'}], 'facility': 'Haukeland university hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Anita Barsnes, MA', 'role': 'CONTACT', 'email': 'anita.barsnes@helse-bergen.no', 'phone': '004790922186'}, {'name': 'Irene Elgen, phd', 'role': 'CONTACT', 'email': 'irene.bircow.elgen@helse-bergen.no', 'phone': '004791550904'}], 'overallOfficials': [{'name': 'Irene Elgen, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haukeland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}