protocolSection identificationModule nctId: NCT06318806, orgStudyIdInfo id: 2024-3633, briefTitle: Towards Remission and Full Recovery From Obsessive-compulsive Disorder, acronym: RCT2023, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-09-30, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them, conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a single site parallel-group randomized-controlled trial with an active run-in treatment. In the first phase of the trial, participants diagnosed with OCD will receive an active run-in treatment consisting of 18 sessions of ERP. In the second phase, non-remitters will be randomly allocated to another 18 sessions of I-CBT or continued treatment with ERP. Non-remission is operationalized in accordance with validated cut-off points established through international consensus and empirical findings (a score of \>12 on the YBOCS and a CGI-S rating of 3 or higher (mild to extremely ill) after the run-in treatment with ERP). I-CBT and continued ERP will be followed by a 6-month and 12-month follow-up conforming to current thinking on relapse and recovery in OCD. Treatments will be administered by trained therapists on a weekly one-on-one basis via videoconferencing for the duration of one hour., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Psychological, outcomesModule primaryOutcomes measure: Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2), primaryOutcomes measure: Clinical Global Impression Scale (CGI), secondaryOutcomes measure: Vancouver Obsessional Compulsive Inventory (VOCI), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Inferential Confusion Questionnaire (ICQ), secondaryOutcomes measure: Dysfunctional Reasoning Processes Task (DRPT), secondaryOutcomes measure: Fear of Self Questionnaire (FSQ-20), secondaryOutcomes measure: Obsessive Beliefs Questionnaire (OBQ-20), secondaryOutcomes measure: Brunnsviken Brief Quality of Life Scale (BBQ), secondaryOutcomes measure: Sheehan Disability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False