Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:41 AM
Study NCT ID:
NCT07469358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCBT for Adolescents Obsessive-compulsive Dissorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety 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': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability (Treatment Acceptability/Adherence Scale, TAAS)', 'timeFrame': 'Baseline and at week 14', 'description': 'The TAAS assesses satisfaction with treatment and adherence.'}, {'measure': 'Child Yale-Brown Obsessive-Compulsive Scale', 'timeFrame': 'Baseline and week 14', 'description': 'The Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) evaluates the severity of obsessive-compulsive disorder symptoms in adolescents. It is a clinician-rated, 10-item scale, with each item rated from 0 (no symptoms) to 4 (extreme symptoms), resulting in a total score ranging from 0 to 40. The scale also provides separate subtotals for the severity of obsessions and compulsions.'}, {'measure': 'Clinical Global Impression (CGI)-Severity', 'timeFrame': 'Baseline and at week 14', 'description': "The CGI rates the severity of the patient's illness at the time of assessment on a 7-point scale, from 1 = normal to 7 = among the most extremely ill patients."}, {'measure': "Children's Depression Inventory", 'timeFrame': 'Baseline and at week 14', 'description': 'The CDI assesses the severity of depressive symptoms in adolescents (12-16).'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline and at week 14', 'description': 'The BDI assesses the severity of depressive symptoms in adolescents (17 years old) and adults.'}, {'measure': 'Negative Effects Questionnaire (NEQ)', 'timeFrame': 'Baseline and at week 14', 'description': 'The NEQ assesses potential negative side effects of the intervention.'}, {'measure': 'Obsessive-Compulsive Inventory Child Version (OCI-CV)', 'timeFrame': 'Baseline and at week 14', 'description': 'The OCI-R assesses obsessive-compulsive symptoms experienced over the past month. It is an 21-item self-report questionnaire covering six symptom dimensions: washing, checking, ordering, obsessing, hoarding, and neutralizing. Each item is rated on a 3-point scale (0 = not at all, 1= sometimes, 2 = always), reflecting the distress caused by the symptom during the past month.'}], 'primaryOutcomes': [{'measure': 'Feasibility (recruitment and retention rates and therapist burden)', 'timeFrame': 'Baseline and at week 14', 'description': 'The investigators will assess feasibility by recording recruitment rates, retention rates, and therapist burden (time spent by the therapist sending emails, reviewing materials, etc.).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obsessive-compulsive disorder', 'cognitive-behavior therapy', 'icbt', 'online treatment', 'e-health'], 'conditions': ['Obsessive Compulsive Disorder (OCD)']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to assess the feasibility, acceptability, and potential effects of therapist-guided internet-delivered cognitive-behavior therapy (iCBT) for adolescent obsessive-compulsive disorder, using a recently developed digital platform.', 'detailedDescription': 'Although cognitive-behavior therapy (CBT) is a well-established first-line treatment for many mental disorders, very few patients receive it due to the shortage of trained professionals, the costs of face-to-face therapy, and geographic barriers. Therapist-guided internet-delivered CBT (iCBT) is a potential solution to this problem but is not generally available in our context.\n\nThe investigators plan to:\n\n1. Develop a digital platform for the treatment of mental disorders using therapist-guided iCBT;\n2. Assess the feasibility, acceptability, and potential effects of therapist-guided iCBT for adolescent obsessive-compulsive disorder (OCD) using the platform developed in Objective 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 12 and 17\n* Internet access\n* Principal diagnosis of OCD, based on DSM-5\n* Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Severity Score \\> 16\n* Ability to communicate in Spanish\n* For participants taking psychotropic medication for OCD: at least eight weeks on stable medication and willingness to stay on the same medication/doses for the 14 weeks of the study\n\nExclusion Criteria:\n\n* Estimated IQ \\< 70, as per the Vocabulary subtest of the Wechsler Intelligence Scale for Children (WISC)\n* Eight or more previous sessions of CBT for OCD with an experienced therapist during the last 12 months\n* Ongoing psychological treatment for OCD\n* Diagnosis of organic brain disorder, intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, low-weight anorexia nervosa, or alcohol/substance dependence\n* Immediate risk to self or others (e.g., suicidality)\n* Inability to communicate in Spanish\n* Low motivation to participate (i.e., the patient does not believe the therapy will be helpful at all)\n* Insufficient time to work on the treatment (about 60 minutes per day)'}, 'identificationModule': {'nctId': 'NCT07469358', 'briefTitle': 'iCBT for Adolescents Obsessive-compulsive Dissorder', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Taking Psychiatry Online: Developing a Platform to Provide Internet-Delivered Cognitive-Behavior Therapy and Testing It in Pediatric Obsessive-Compulsive Disorder', 'orgStudyIdInfo': {'id': 'HCB/2023/0284'}, 'secondaryIdInfos': [{'id': 'HCB/2023/0284', 'type': 'OTHER', 'domain': 'Hospital Clínic of Barcelona'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Interned-delivered Cognitive-Behavioral Therapy (CBT)', 'interventionNames': ['Behavioral: Behavioral: icbt.']}], 'interventions': [{'name': 'Behavioral: icbt.', 'type': 'BEHAVIORAL', 'description': '14-Week Therapist-Based iCBT for pediatric OCD', 'armGroupLabels': ['Experimental: Interned-delivered Cognitive-Behavioral Therapy (CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}