Psychotherapy for Obsessive-Compulsive Disorder
(RCT2023 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ciusss de L'Est de l'Île de Montréal
Disqualifiers: Suicidal ideation, Psychotic disorder, Substance abuse, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of 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
Will I have to stop taking my current medications?
No, you won't have to stop taking your current medications, but you need to keep them stable while participating in the study. This means no changes in your medication for 8 weeks before starting the treatment for antidepressants and 4 weeks for anxiolytics.
What data supports the effectiveness of the treatment Exposure and Response Prevention (ERP) for Obsessive-Compulsive Disorder?
Research shows that Exposure and Response Prevention (ERP) is an effective treatment for reducing symptoms in people with obsessive-compulsive disorder (OCD). It is considered the most supported psychological treatment for OCD, and studies have shown it can also help with tic symptoms in conditions like Tourette syndrome.
12345Is Exposure and Response Prevention (ERP) therapy safe for treating OCD?
Some therapists have concerns about the safety of ERP, especially for certain OCD symptoms, but there is no specific evidence of serious negative consequences from the therapy itself.
12467How is Exposure and Response Prevention (ERP) treatment different from other treatments for obsessive-compulsive disorder (OCD)?
Exposure and Response Prevention (ERP) is unique because it involves gradually exposing patients to their fears or obsessions and helping them resist the urge to perform compulsive behaviors, which is different from other treatments that may focus more on cognitive restructuring or medication. ERP is considered the most empirically supported psychological treatment for OCD, and it can also be effective for related conditions like Tourette syndrome.
23589Eligibility Criteria
This trial is for adults with a primary diagnosis of OCD, scoring at least 18 on the Y-BOCS. Participants must have stable medication use for weeks prior and agree to maintain it during the study. They should not be at high risk of suicide or have certain other mental health conditions, substance abuse issues, or severe cognitive disorders that could interfere with treatment.Inclusion Criteria
Eligibility criteria for participation in the trial includes: (a) a primary diagnosis of OCD according to DSM-5 criteria, b) a score ≥ 18 on the Y-BOCS (c) age ≥ 18; (d) no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics), (e) willingness to keep medication stable while participating in the study, (f) no evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts, (g) no past or present psychotic or bipolar disorder, (h) no neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first, (i) no evidence of a substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first; (i) not undergoing a concurrent psychological treatment, (j) access to a computer or phone with internet access
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Run-in Treatment
Participants undergo initial treatment with Exposure and Response Prevention (ERP) to assess remission status
9 weeks
Randomized Treatment
Participants who do not reach remission are randomized to either Inference-Based Cognitive Behavioral Therapy (I-CBT) or continued ERP
18 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The trial tests whether Inference-based Cognitive Behavioral Therapy (I-CBT) can help those who didn't fully recover from OCD after Exposure and Response Prevention (ERP) therapy. It compares additional ERP against I-CBT in patients post-initial ERP treatment, aiming to personalize future treatments by predicting individual responses.
2Treatment groups
Experimental Treatment
Active Control
Group I: Inference-based Cognitive Behavioral TherapyExperimental Treatment1 Intervention
CBT will be delivered in accordance with published guidelines and protocols that target the dysfunctional reasoning giving rise to obsessional doubts. The first learning point in I-CBT is that the compulsions, anxiety and discomfort are driven by an initial obsessional doubt. The principal focus of treatment is to show that the doubt is 100% irrelevant in the here and now. To this end the reasoning narrative is identified, including the reasoning distortions contained therein, giving undue credibility to the obsessional doubt. The selective nature of the doubt is underlined by showing the client how under most everyday circumstances his/her reasoning is entirely different from the obsessional situation. This stage also educates the client in the thematic nature of the obsessional doubt and how personal themes dictate the idiosyncratic nature of the person's obsession. The final stage of therapy consists of training the client in the proper use of the senses.
Group II: Exposure and Response PreventionActive Control1 Intervention
ERP will be delivered in accordance with published guidelines and protocols that employ inhibitory learning principles. Following the creation of a hierarchy of feared situations, patients are encouraged to confront their fears (both during and in-between treatment sessions) while abstaining from engaging in compulsions and other neutralizing strategies (i.e., response prevention). Exercises consist of exposure in vivo (i.e., exposure in real life situations) and/or imaginal exposure that are initially conducted in sessions under the therapist's guidance, and then as daily homework designed by the therapist in collaboration with the patient. In accordance with an inhibitory learning model, rather than focusing on habituation to anxiety, exercises aim to maximize outcomes through expectancy violation, deepened extinction, elimination of safety behaviors during exposure, exposure in multiple contexts, and affect labeling during exposure.
Exposure and Response Prevention (ERP) is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Exposure and Response Prevention for:
- Obsessive-compulsive disorder (OCD)
🇺🇸 Approved in United States as Exposure and Response Prevention for:
- Obsessive-compulsive disorder (OCD)
🇨🇦 Approved in Canada as Exposure and Response Prevention for:
- Obsessive-compulsive disorder (OCD)
🇦🇺 Approved in Australia as Exposure and Response Prevention for:
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institut universitaire en santé mentale de MontréalMontréal, Canada
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Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. [2019]Behavior therapy [exposure and response prevention (ERP)] and cognitive therapy (CT) have proven effective in the treatment of obsessive-compulsive disorder. Direct comparisons between these treatment modalities have exposed no differences in efficacy. However, very little research has been conducted into the differences between the change processes in ERP and CT. This investigation is a first attempt to study change by measuring scores on a weekly basis rather than at specific stages in the treatment and follow-up.
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. [2022]Exposure and response prevention (ERP) is a form of cognitive behavioral therapy that can effectively relieve obsessive-compulsive symptoms and tic symptoms in patients with obsessive-compulsive disorder (OCD) and Tourette syndrome (TS). However, the effect size of ERP-based therapy is still unclear.
Cognitive behavioural therapy with exposure and response prevention in the treatment of obsessive-compulsive disorder: A systematic review and meta-analysis of randomised controlled trials. [2021]Cognitive behavioural therapy (CBT), incorporating exposure and response prevention (ERP) is widely recognised as the psychological treatment of choice for obsessive-compulsive disorder (OCD). Uncertainty remains however about the magnitude of the effect of CBT with ERP and the impact of moderating factors in patients with OCD.
Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. [2020]While exposure and response prevention (ERP) is the most effective treatment for obsessive compulsive disorder (OCD), less is known about the specific mechanisms underlying symptom change after ERP.
Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting. [2022]Exposure and response prevention (ERP) remains the most empirically supported psychological treatment for obsessive compulsive disorder (OCD). Clinical guidelines recommend the addition of cognitive approaches to ERP although the presumed additive benefits have not been directly tested. The aim of this was to compare a treatment that integrated cognitive therapy with ERP (ERP + CT) to traditional, manualized ERP to test the additive benefits.
Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]Many therapists are reluctant to conduct exposure and response prevention (ERP) for obsessive-compulsive disorder (OCD). Negative beliefs about the safety and tolerability of ERP are common, especially for harm-related OCD symptoms. The study examined the nature and frequency of ERP-related serious negative consequences (SNC) and therapist attitudes and experiences providing ERP for harm-related OCD.
How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. [2018]Exposure and response prevention (ERP) is an effective treatment for individuals with obsessive-compulsive disorder (OCD), yet a substantial number of individuals with OCD do not fully respond to this intervention. Based on emerging experimental and clinical research on acceptance, this study sought to explore whether willingness to experience unpleasant thoughts, emotions, and bodily sensations during ERP was associated with improved treatment response.
Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]Behaviour therapy with exposure and response prevention (ERP) or cognitive behavioural therapy (CBT) including ERP are considered the psychological treatments of choice for obsessive-compulsive disorder (OCD), but group CBT/ERP has received relatively little research attention in the treatment of OCD. The aim of this study was to provide a meta-analysis of the effectiveness of group CBT/ERP for OCD.
The psychological treatment of obsessive-compulsive disorder. [2019]The psychological treatment of obsessive-compulsive disorder (OCD) with exposure and response prevention (ERP) methods is one of the great success stories within the field of mental health. Within the span of about 20 years, the prognosis for individuals with OCD has changed from poor to very good as a result of the development of ERP. This success not with-standing, the procedures are far from perfect because a substantial minority of patients still either refuse treatment, drop out prematurely, or fail to benefit. I begin this article with a review of the development of ERP from early animal research on avoidance learning conducted during the 1950s. Next, I discuss the mechanisms of ERP. The bulk of the article reviews the treatment-outcome literature on ERP for OCD and includes comparisons with cognitive therapy--the "new kid on the block" with respect to psychological treatments for OCD.