Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-02 @ 8:34 AM
Study NCT ID:
NCT03261557
Status:
UNKNOWN
Last Update Posted:
2017-08-25
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Social Skills Training in Early Onset Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychosocial functioning', 'timeFrame': '15 weeks', 'description': 'Change from baseline in social functioning questionnaires'}, {'measure': 'Clinical symptoms', 'timeFrame': '15 weeks', 'description': 'Change from baseline in Clinical scales'}], 'secondaryOutcomes': [{'measure': 'Biological stress markers', 'timeFrame': '15 weeks', 'description': 'Change pre-post interventionbiological stress markers registered by blood analyses'}, {'measure': 'Subjective stress', 'timeFrame': '15 weeks', 'description': 'Change pre-post intervention in questionnaires of perceived stress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Psychosis NOS']}, 'descriptionModule': {'briefSummary': 'Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. In patients with early onset psychotic disorder (EOP) there are not any previous controlled study that has analyzed the efficacy of this type of intervention.\n\nThe aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional improvement after the treatment in patients with EOP. The study will also examine the potential effect of the intervention on neurobiological stress markers.', 'detailedDescription': 'Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. In the case of patients with EOP, international and national clinical guidelines recommend the combination of pharmacological treatment with CBT. However there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention.\n\nA controlled randomized study will be carry out of CBT + SST intervention compared to a control intervention of the same duration, format and contact with a therapist. The sample will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. All participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. The evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 20.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to DSM-V criteria).\n* Critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment\n\nExclusion Criteria:\n\n* IQ \\<70\n* Toxic dependence comorbid disorder\n* Presence of Neurological disorder.'}, 'identificationModule': {'nctId': 'NCT03261557', 'briefTitle': 'Cognitive Behavioral Social Skills Training in Early Onset Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.', 'orgStudyIdInfo': {'id': 'DN040595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT + SST', 'description': 'The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.', 'interventionNames': ['Behavioral: CBT + SST']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation, habits and healthy lifestyle', 'description': 'The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.', 'interventionNames': ['Behavioral: Psychoeducation, habits and healthy lifestyle']}], 'interventions': [{'name': 'CBT + SST', 'type': 'BEHAVIORAL', 'description': 'It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module.\n\nAll patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.', 'armGroupLabels': ['CBT + SST']}, {'name': 'Psychoeducation, habits and healthy lifestyle', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle.\n\nAll patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.', 'armGroupLabels': ['Psychoeducation, habits and healthy lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Olga Puig, PhD', 'role': 'CONTACT', 'email': 'opuig@clinic.ub.es', 'phone': '34 227', 'phoneExt': '99 74'}], 'facility': 'Department of Child and Adolescent Pyshicatry and Psychology', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Olga Puig, PhD', 'role': 'CONTACT', 'email': 'opuig@clinic.ub.es', 'phone': '93 227 99 74'}], 'overallOfficials': [{'name': 'Olga Puig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical psychologist', 'investigatorFullName': 'Olga Puig', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}