Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:31 PM
Study NCT ID:
NCT07464561
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESCCUE4 - Group CBT for Social Anxiety in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and outcome assessors will be blinded to treatment allocation. Therapists delivering the interventions will not be blinded due to the nature of the behavioral treatments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Interpersonal Difficulties (CDI-2 Interpersonal Problems)', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': "Change from baseline to post-treatment and 1-month follow-up in interpersonal difficulties measured by the Children's Depression Inventory, Second Edition (CDI-2) Interpersonal Problems subscale. The CDI-2 is a self-report questionnaire assessing depressive symptoms in children and adolescents. Scores on the Interpersonal Problems subscale range from 0 to 12, with higher scores indicating greater interpersonal difficulties."}, {'measure': 'Change in Emotional Regulation', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': 'Change from baseline to post-treatment and 1-month follow-up in emotional regulation difficulties measured by the Difficulties in Emotion Regulation Scale (DERS). Higher scores indicate greater difficulties in emotion regulation.'}, {'measure': 'Change in Peer and School Functioning (HONOSCA)', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': 'Change from baseline to post-treatment and 1-month follow-up in peer and school functioning measured by selected items of the Health of the Nation Outcome Scales for Children and Adolescents (HONOSCA), specifically the items assessing peer relationship problems and school attendance difficulties. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of problems.'}, {'measure': 'Change in Emotional and Peer Problems (SDQ)', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': 'Change from baseline to post-treatment and 1-month follow-up in emotional and peer difficulties measured by the Strengths and Difficulties Questionnaire (SDQ) Emotional Symptoms and Peer Problems subscales. Each subscale score ranges from 0 to 10, with higher scores indicating greater emotional and peer difficulties.'}], 'primaryOutcomes': [{'measure': 'Change in Social Anxiety Symptoms (MASC-2)', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': 'Change from baseline to post-treatment in social anxiety symptoms measured by the Multidimensional Anxiety Scale for Children (MASC-2) Social Anxiety T-score.\n\nThe MASC-2 is a self-report questionnaire assessing anxiety symptoms in youth. T-scores range from 0 to 100, with higher scores indicating greater anxiety severity.'}], 'secondaryOutcomes': [{'measure': 'Change in Social Anxiety Symptoms (LSAS)', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': 'Change from baseline to post-treatment in social anxiety symptoms measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS assesses fear/anxiety and avoidance across social situations. Scores range from 0 to 144, with higher scores indicating greater social anxiety severity.'}, {'measure': 'Change in Global Functioning', 'timeFrame': 'Baseline to 2 months and 3 months', 'description': "Change from baseline to post-treatment and 1-month follow-up in global functioning measured by the Children's Global Assessment Scale (C-GAS). Higher scores indicate better functioning."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Behavioral Therapy', 'Adolescents', 'Group Therapy', 'Social Withdrawal', 'Psychoeducation', 'Anxiety Symptoms'], 'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '32439401', 'type': 'BACKGROUND', 'citation': 'Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.'}, {'pmid': '33148187', 'type': 'BACKGROUND', 'citation': 'Qiu JJ, Yang RZ, Tang YJ, Lin YY, Xu HJ, Zhang N, Liang M, Cai HD, Zeng K, Wu XD. BRD4 and PIN1 gene polymorphisms are associated with high pulse pressure risk in a southeastern Chinese population. BMC Cardiovasc Disord. 2020 Nov 4;20(1):475. doi: 10.1186/s12872-020-01757-x.'}]}, 'descriptionModule': {'briefSummary': "This randomized controlled trial aims to evaluate the efficacy of a 2-month group Cognitive Behavioral Therapy (CBT) intervention compared to a structured psychoeducational treatment as usual (TAU) in adolescents diagnosed with Social Anxiety Disorder.\n\nParticipants aged 12 to 17 years will be recruited from the Child and Adolescent Neuropsychiatry Day Hospital at Bambino Gesù Children's Hospital (Rome, Italy).\n\nThe primary objective is to assess the reduction of social anxiety symptoms following the CBT intervention compared to TAU. Secondary objectives include improvement in global functioning, interpersonal relationships, emotional regulation, and reduction of social withdrawal. Assessments will be conducted at baseline, post-treatment (2 months), and 1-month follow-up.", 'detailedDescription': 'This monocentric, no-profit randomized controlled trial will enroll 34 adolescents aged 12-17 years with a DSM-5 diagnosis of Social Anxiety Disorder. Participants will be randomly assigned in a 1:1 ratio to either a group Cognitive Behavioral Therapy (CBT) intervention or a structured psychoeducational treatment as usual (TAU). Randomization will be stratified by age (12-14 years; 15-17 years).\n\nBoth interventions will consist of eight weekly group sessions (90 minutes each) delivered over a 2-month period.\n\nThe CBT intervention includes psychoeducation about social anxiety, identification of maladaptive automatic thoughts, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises based on a subjective distress hierarchy (SUDs), social skills training, metacognitive exercises, and relapse prevention strategies.\n\nThe active comparator (TAU) consists of structured group psychoeducational sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies.\n\nOutcome assessments will be conducted at baseline (T0), post-treatment (T2), and at 1-month follow-up (T3) by blinded evaluators. The primary outcome is the change in social anxiety symptoms measured through validated self-report scales. Secondary outcomes include changes in global functioning, interpersonal difficulties, emotional regulation, and general psychopathology.\n\nThe study aims to determine whether group CBT provides superior clinical improvement compared to structured psychoeducational treatment in adolescents with Social Anxiety Disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 12 and 17 years\n* DSM-5 diagnosis of Social Anxiety Disorder\n* Access to the Child and Adolescent Neuropsychiatry Day Hospital\n* Willingness of the participant and family to participate in the study\n* Written informed consent provided by parents or legal guardians\n\nExclusion Criteria:\n\n* Age below 12 years\n* Intellectual disability\n* Lack of family compliance with treatment\n* Withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT07464561', 'briefTitle': 'RESCCUE4 - Group CBT for Social Anxiety in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'REcover Spaces for Traumatized Children in CommUnity sEttings Post COVID-19 (RESCCUE4): A Double-Blind Controlled Trial Comparing Group Cognitive Behavioral Therapy Versus Treatment as Usual in Adolescents With Social Anxiety Disorder', 'orgStudyIdInfo': {'id': 'RESCCUE4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Cognitive Behavioral Therapy', 'description': 'Participants assigned to this arm will receive an 8-week group Cognitive Behavioral Therapy (CBT) intervention consisting of weekly 90-minute sessions. The intervention includes psychoeducation about social anxiety, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises, social skills training, metacognitive exercises, and relapse prevention strategies.', 'interventionNames': ['Behavioral: Group Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Structured Psychoeducational Treatment (TAU)', 'description': 'Participants assigned to this arm will receive an 8-week structured group psychoeducational intervention consisting of weekly 90-minute sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies.', 'interventionNames': ['Behavioral: Psychoeducational Group Intervention']}], 'interventions': [{'name': 'Group Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'A structured 8-session group Cognitive Behavioral Therapy program delivered weekly over 2 months. Sessions include psychoeducation, identification of maladaptive automatic thoughts, cognitive restructuring, exposure techniques based on a subjective distress hierarchy (SUDs), breathing techniques, social skills training, and relapse prevention.', 'armGroupLabels': ['Group Cognitive Behavioral Therapy']}, {'name': 'Psychoeducational Group Intervention', 'type': 'BEHAVIORAL', 'description': 'A structured 8-session group psychoeducational program delivered weekly over 2 months. Sessions focus on emotional literacy, understanding emotional processes, awareness of somatic manifestations of anxiety, and development of emotion regulation strategies.', 'armGroupLabels': ['Structured Psychoeducational Treatment (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Paola De Rose, MD, Child and Adolescent Neuropsychiatrist', 'investigatorFullName': 'Paola De Rose', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}