Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 10:20 PM
Study NCT ID:
NCT02541968
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)', 'timeFrame': 'Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression - Severity (CGI-S)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Global Assessment of Functioning (GAF)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.', 'description': 'Diagnostic status'}, {'measure': 'Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Obsessive-Compulsive Inventory - Revised (OCI-R)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Euroqol (EQ-5D)', 'timeFrame': 'Change from baseline to treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'Treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Treatmentweek 15, 3- and 12-month follow-up.'}, {'measure': 'Treatment credibility scale', 'timeFrame': 'Change from baseline to treatmentweek 2.'}, {'measure': 'Satisfaction with treatment scale', 'timeFrame': 'Treatmentweek 15'}, {'measure': 'TiC-P', 'timeFrame': 'Treatmentweek 0, 15, 3- and 12-month follow-up.', 'description': 'Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder'}, {'measure': 'Safety Monitoring Uniform Report Form (SMURF)', 'timeFrame': 'Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.'}, {'measure': 'Patient EX/RP Adherence Scale (PEAS)', 'timeFrame': 'Treatmentweek 6 and 15'}, {'measure': 'Working Alliance Inventory - short revised', 'timeFrame': 'Change from baseline to treatment week 6 and 15'}]}, 'conditionsModule': {'conditions': ['Obsessive-compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '25970252', 'type': 'BACKGROUND', 'citation': 'Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljotsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Ruck C. D-Cycloserine vs Placebo as Adjunct to Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder and Interaction With Antidepressants: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jul;72(7):659-67. doi: 10.1001/jamapsychiatry.2015.0546.'}, {'pmid': '25066102', 'type': 'BACKGROUND', 'citation': 'Andersson E, Steneby S, Karlsson K, Ljotsson B, Hedman E, Enander J, Kaldo V, Andersson G, Lindefors N, Ruck C. Long-term efficacy of Internet-based cognitive behavior therapy for obsessive-compulsive disorder with or without booster: a randomized controlled trial. Psychol Med. 2014 Oct;44(13):2877-87. doi: 10.1017/S0033291714000543. Epub 2014 Mar 14.'}, {'pmid': '35285923', 'type': 'RESULT', 'citation': 'Lundstrom L, Flygare O, Andersson E, Enander J, Bottai M, Ivanov VZ, Boberg J, Pascal D, Mataix-Cols D, Ruck C. Effect of Internet-Based vs Face-to-Face Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221967. doi: 10.1001/jamanetworkopen.2022.1967.'}, {'pmid': '30185575', 'type': 'DERIVED', 'citation': 'Ruck C, Lundstrom L, Flygare O, Enander J, Bottai M, Mataix-Cols D, Andersson E. Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder. BMJ Open. 2018 Sep 5;8(9):e022254. doi: 10.1136/bmjopen-2018-022254.'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults.\n\nThe primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general.\n\nResearch Questions:\n\nQ1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life?\n\nQ2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life?\n\nQ3: Is ICBT a cost-effective treatment, compared to f2f CBT?\n\nQ4: Is there a difference in treatment outcome between self-referred and clinical referred patients?\n\nQ5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age,\n* Internet access,\n* primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),\n* Written consent of participation in the study.\n\nExclusion Criteria:\n\n* Other psychological treatment for OCD during the treatment period,\n* Adjustment of concurrent psychotropic medication within the last two months,\n* bipolar disorder,\n* psychosis,\n* alcohol or substance dependence,\n* completed CBT for OCD in the last 12 months,\n* hoarding disorder or OCD with primary hoarding symptoms,\n* suicidal ideation,\n* subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material,\n* Autism spectrum disorder,\n* organic brain disorder.'}, 'identificationModule': {'nctId': 'NCT02541968', 'briefTitle': 'Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'OCD F2F vs ICBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Face-to-face CBT', 'description': '16 sessions of individual CBT delivered in 14 weeks.', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy (face-to-face)']}, {'type': 'EXPERIMENTAL', 'label': 'Internet-based CBT', 'description': 'Internet-based CBT (ICBT) with therapist support (14 weeks).', 'interventionNames': ['Behavioral: Internet-based Cognitive-behavioral therapy']}, {'type': 'EXPERIMENTAL', 'label': 'ICBT without therapist support', 'description': 'Internet-based CBT without therapist support (14 weeks).', 'interventionNames': ['Behavioral: Internet-based Cognitive-behavioral therapy without therapist support']}], 'interventions': [{'name': 'Cognitive-behavioral therapy (face-to-face)', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'armGroupLabels': ['Face-to-face CBT']}, {'name': 'Internet-based Cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ICBT'], 'description': 'With therapist support', 'armGroupLabels': ['Internet-based CBT']}, {'name': 'Internet-based Cognitive-behavioral therapy without therapist support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['ICBT without therapist support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Mottagningen för Tvångssyndrom', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}], 'overallOfficials': [{'name': 'Christian Rück', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christian Rück', 'investigatorAffiliation': 'Karolinska Institutet'}}}}