Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT05802758
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CFT-focused Mental Health Intervention With Exposure Training for Youngsters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019955', 'term': 'Conduct Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-03-25', 'studyFirstSubmitQcDate': '2023-03-25', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The self-reported change in Youth Pysychopathic traits Inventory- short version (YPI-S) and in the factors of it', 'timeFrame': '5 months', 'description': 'Measures both conduct prolems and psychopathic traits'}], 'secondaryOutcomes': [{'measure': 'Short Warwick-Edinburgh Wellbeing scale (SWEMWBS)', 'timeFrame': '5months', 'description': 'measures general psychosocial well-being'}, {'measure': 'Difficulties in Emotion Regulating Scale-Short form (DERS-SF)', 'timeFrame': '5 months', 'description': 'measures emotion regulation style'}, {'measure': "WHO's quality of life questionnaire- Brief version (WHOQOL-BREF)", 'timeFrame': '5 months', 'description': 'measures quality of life'}, {'measure': 'Self-Compassion Scale- Short Form (SCS-SF)', 'timeFrame': '5 months', 'description': 'measures self-compassion'}, {'measure': 'Santa Clara Compassion Scale', 'timeFrame': '5 months', 'description': 'masures compassion against other people'}, {'measure': "Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE)", 'timeFrame': '5 months', 'description': 'measures how the intervention is felt by the youngster'}, {'measure': 'Situational intrinsic and extrinsic motivation scale (SIMS)', 'timeFrame': '5 months', 'description': "measures younster's motivation to participate the intervention"}, {'measure': 'Toronto Alexitymia Scale (TAS-20)', 'timeFrame': '5 months', 'description': 'measures aleksitymia'}, {'measure': 'The Personal Feelings Questionnaire- brief version (PFQ-2 Brief)', 'timeFrame': '5 months', 'description': 'measures feelings of quilt'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychotherapy, virtual reality, boys'], 'conditions': ['Conduct Disorder', 'Psychopathic Personality Trait']}, 'descriptionModule': {'briefSummary': "The aim of this study is to explore if individual CFT-based intervention with exposure training in virtual reality decreases conduct disorder symptoms and callous-unemoitonal traits , as well as increases subjective emotional welbeing among 15-to-20 year-old male prisoners and boys placed to state's residential schools. We will also study factors that may predict adherence to the intervention. These factors include mental well-being, motivation, and working alliance. In addition, we will evaluate the costs of the program."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Express conduct disorder psychopathology and psychopathic personality traits\n* Are placed to a prison or a state residential school for at least 9 months\n\nExclusion Criteria:\n\n* Females\n* Non-Finninsh-speaking\n* Remaining in the institution facility less than 9 months\n* Intellectual dissability\n* Presence of psychotic symptoms\n* Autism\n* History of epilepsy\n* Currently participating another psychotherapeutic intervention'}, 'identificationModule': {'nctId': 'NCT05802758', 'acronym': 'CFT+VR', 'briefTitle': 'CFT-focused Mental Health Intervention With Exposure Training for Youngsters', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Compassion-focused Mental Health Intervention With Exposure Training in Virtual Reality for Youngsters Living in an Institution', 'orgStudyIdInfo': {'id': 'HUS/345/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Youngsters who get CFT + VR', 'description': 'yougsters, who get compassion-focused short intervention together with training in virtual reality together with general psychosocial rehabilitation offered by prisons and state residential schools', 'interventionNames': ['Behavioral: Psychopathy.comp and training in virtual reality (VR)']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'youngsters, who get only general psychosocial rehabilitation offered by prisons and state residential schools'}], 'interventions': [{'name': 'Psychopathy.comp and training in virtual reality (VR)', 'type': 'BEHAVIORAL', 'description': 'Psychopathy.comp is a CFT-based manualized program of 20 sessions a 60 min, on a weekly basis. During the CFT-intervention, partipants try out their new skills in a tailored VR setting (x5)', 'armGroupLabels': ['Youngsters who get CFT + VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00271', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Marko Manninen, PhD', 'role': 'CONTACT', 'email': 'marko.manninen@thl.fi', 'phone': '+358405605090'}, {'name': 'Mirva Heikkilä, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Residential Schools', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00530', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Nina Lindberg', 'role': 'CONTACT', 'email': 'nina.lindberg@hus.fi', 'phone': '+358504270028'}, {'name': 'Jenni Kaunomäki, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prison and Probation Service of Finland', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Nina Lindberg, PhD', 'role': 'CONTACT', 'email': 'nina.lindberg@hus.fi', 'phone': '+358504270028'}], 'overallOfficials': [{'name': 'Nina Lindberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior doctor, professor', 'investigatorFullName': 'Nina Lindberg', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}