Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT05906069
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D003193', 'term': 'Compulsive Personality Disorder'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The psychologist performing the assessment of the main psychometric outcomes will be blind to the group allocation of each participant.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'OCD patients will be randomly allocated into two groups - iCBT group (experimental group) and wait list group (comparator control group). The experimental group will receive a 14-week iCBT intervention program and the wait list group will receive the same intervention but at a later time.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess obsessive-compulsive symptoms'}], 'secondaryOutcomes': [{'measure': 'Obsessive-Compulsive Inventory- Revised', 'timeFrame': 'baseline; 4 weeks after beginning intervention/waitlist; 8 weeks after beginning; 12 weeks after beginning intervention/waitlist and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess obsessive-compulsive symptoms'}, {'measure': 'Hamilton Anxiety Scale', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess anxiety symptoms'}, {'measure': 'Hamilton Depression Scale', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess depression symptoms'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess stress symptoms'}, {'measure': 'Emotion Regulation Questionnaire', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess cognitive regulation and emotional suppression capabilities'}, {'measure': 'Difficulties in Emotion Regulation Scale', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess emotion deregulation'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'immediately before and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess affect'}, {'measure': 'Depression Anxiety Stress scale', 'timeFrame': 'baseline; every week during intervention/wait list (up to 14 weeks) and immediately after intervention/waitlist', 'description': 'Psychometric scale to assess symptoms of anxiety, depression and stress'}, {'measure': 'NEO Five-Factor Inventory', 'timeFrame': 'baseline', 'description': 'Psychometric scale to assess personality traits'}, {'measure': 'Treatment Acceptability/Adherence Scale', 'timeFrame': 'immediately after intervention', 'description': 'Psychometric scale to assess treatment adherence'}, {'measure': 'University of Rhode Island Change Assessment Scale', 'timeFrame': 'baseline', 'description': 'Psychometric scale to assess motivation to change'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obsessive-compulsive disorder', 'ocd', 'neuroimaging', 'emotion regulation', 'internet-based cognitive behavioral therapy'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'In the current study, the investigators will characterize obsessive-compulsive disorder (OCD) patients and healthy controls with a comprehensive clinical and neuroimaging assessment, focusing on the basic psychological processes related and on the neurobiological underpinnings of emotion regulation (ER). After a baseline assessment, the investigators will implement an internet-based cognitive behavioral therapy (iCBT) protocol and assess its efficacy on the modulation of ER and OCD severity. Specifically, the investigators will (1) examine to what extent the iCBT intervention modulates ER and the associated neurobiological mechanisms and (2) identify candidate biomarkers of successful treatment response.', 'detailedDescription': "Sixty patients and sixty controls will be recruited at Hospital de Braga, Braga, Portugal (sample size estimated based on a previous systematic review). A power analysis indicated that a sample of 24 individuals per group is adequate to detect an effect size of d=.89, with a Type I error of .05 and a statistical power of .85. A final sample of 30 individuals was defined to account for a 20% dropout rate during the intervention.\n\nAll participants will be assessed with a comprehensive psychological and clinical characterization. Following the baseline assessment, OCD patients will be randomly allocated to the intervention (iCBT intervention) or the control group (waiting list). The iCBT intervention will consist of a structured program comprising 10 modules with text and video content, as well as 3 videoconferencing psychotherapy sessions. After the intervention/waiting list, patients will be re-assessed with the clinical and psychological assessment.\n\nIn order to characterize the patterns of brain activation in OCD patients during an emotion regulation task in comparison to healthy controls and to identify potential neurobiological markers of symptoms' improvement, a multimodal neuroimaging assessment will also be performed. The task encompasses the presentation of pictures (fearful, neutral and OCD-related stimuli) under two conditions: the instruction to view the pictures naturally ('observe'); or to apply cognitive reappraisal techniques to decrease any negative affective state caused by the stimuli ('regulate'). Fear and OCD-related pictures are presented during both conditions; neutral pictures only during 'observe'. After each stimulus, the level of distress will be assessed by a self-report rating scale.\n\nIn the baseline assessment, brain activation patterns (with whole-brain and region of interest approaches) will be compared between OCD and healthy controls in both task conditions. After intervention, emotion regulation ability and the underlying neurobiological mechanisms will be compared between the 'intervention' and 'waiting list' groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders\n* YBOCS score ≥ 16\n* Psychotropic medication, if stable for at least 2 months prior to inclusion and if the dosage is maintained thoughout the study\n* Have the resources to access the online intervention (internet access; computer or tablet)\n\nExclusion Criteria:\n\n* MRI contraindications\n* Prior medical history of neurological disorders or traumatic brain injury\n* Having performed CBT treatment for OCD in the last 2 years\n* Undergoing any psychological treatment\n* Suicidal ideation\n* Current alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT05906069', 'acronym': 'iTREATOCD', 'briefTitle': 'ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy in Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Minho'}, 'officialTitle': 'ITreatOCD: Predicting the Efficacy of Internet-based Cognitive Behavioral Therapy from Changes in the Neurobiological Correlates of Emotion Regulation in Obsessive-compulsive Disorder', 'orgStudyIdInfo': {'id': 'iTREATOCD_ICVS2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iCBT intervention', 'description': 'Participants will enroll in an internet-based cognitive behavioral program during 14 weeks. The program comprises 10 modules and three videoconferencing psychotherapy sessions.', 'interventionNames': ['Behavioral: ICBT']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list', 'description': 'Participants will be enrolled in the iCBT program after 14 weeks'}], 'interventions': [{'name': 'ICBT', 'type': 'BEHAVIORAL', 'description': 'The intervention will consist in a structured internet-based intervention with 10 modules that will combine cognitive-behavioral techniques to improve obsessive-compulsive symptoms as well as the emotion regulation ability.', 'armGroupLabels': ['iCBT intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4710-057', 'city': 'Braga', 'state': 'Gualtar', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Pedro Morgado, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'pedromorgado@med.uminho.pt', 'phone': '00351 253 604 931'}, {'name': 'Mafalda Sousa, M. Sc.', 'role': 'CONTACT', 'email': 'id9534@alunos.uminho.pt'}], 'facility': 'Life and Health Sciences Research Institute, School of Medicine, University of Minho', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}], 'centralContacts': [{'name': 'Pedro Morgado, M.D, Ph.D.', 'role': 'CONTACT', 'email': 'pedromorgado@med.uminho.pt', 'phone': '+351 253 604 931'}, {'name': 'Mafalda Sousa, M., Sc.', 'role': 'CONTACT', 'email': 'id9534@alunos.uminho.pt'}], 'overallOfficials': [{'name': 'Pedro Morgado, M.D, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pedro Morgado', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Braga', 'class': 'OTHER'}, {'name': 'ICVS - Life and Health Sciences Research Institute', 'class': 'UNKNOWN'}, {'name': 'Clinical Academic Center (2CA)', 'class': 'UNKNOWN'}, {'name': 'Associação Centro de Medicina P5 (ACMP5)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, M.D., Ph.D.', 'investigatorFullName': 'Pedro Morgado', 'investigatorAffiliation': 'University of Minho'}}}}