Testing Psychotherapy for obsessive-compulsive disorder
Official title: Towards Remission and Full Recovery From Obsessive-compulsive Disorder
Towards Remission and Full Recovery From Obsessive-compulsive Disorder: Investigating the Efficacy of Inference-Based Cognitive-Behavioral Therapy When Standard Treatment Has Failed
Interventions
Psychotherapy
Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.
Canadian Sites (1)
Institut universitaire en santé mentale de Montréal
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +a primary diagnosis of OCD according to DSM-5 criteria.
- +a score ≥ 18 on the Y-BOCS
- +no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics).
- +willingness to keep medication stable while participating in the study.
- +not undergoing a concurrent psychological treatment.
- +access to a computer or phone with internet access.
Exclusion
- −evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts.
- −past or present psychotic or bipolar disorder.
- −neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first.
- −substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Psychotherapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 160 people.
The study is currently expected to finish around September 2029.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, change after 12-month follow-up.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, change after 12-month follow-up.
Clinical Global Impression Scale (CGI) — measured over Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06318806 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PsychotherapyOther
Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, change after 12-month follow-up.
The study as a whole is currently expected to finish around 2029-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 160 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.