Psychotherapy for Obsessive-Compulsive Disorder

(RCT2023 Trial)

Recruiting at 1 trial location

Overseen By Lysandre Bourguignon, Msc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Suicidal ideation, Psychotic disorder, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better treatments for obsessive-compulsive disorder (OCD), a condition involving unwanted thoughts and repetitive actions. Researchers aim to determine if Inference-based Cognitive Behavioral Therapy (I-CBT) is more effective than traditional methods for individuals who haven't found relief with Exposure and Response Prevention (ERP) therapy. Participants will either continue with ERP or switch to I-CBT to assess which treatment offers more help. This trial targets those with OCD who have tried ERP but still struggle with symptoms and wish to explore new therapy options. As an unphased trial, it provides a unique opportunity for participants to explore innovative therapies that might offer relief where traditional methods have not.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Exposure and Response Prevention (ERP) therapy is generally safe for treating OCD. Studies have found that ERP improves patients' symptoms. This therapy gradually helps people face their fears safely. While some might find it challenging, serious side effects are rare.

Inference-based Cognitive Behavioral Therapy (I-CBT) is another treatment option that is as safe and effective as ERP. I-CBT helps patients understand and manage the doubtful thoughts leading to compulsive behaviors. Research suggests that I-CBT is easier for patients to follow and more acceptable than ERP, making it a good choice for those who find traditional methods difficult.

Both treatments have undergone extensive study and are generally well-tolerated. Prospective trial participants can feel reassured by the research supporting these therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapies for Obsessive-Compulsive Disorder (OCD) that often focus on reducing anxiety through habituation, Exposure and Response Prevention (ERP) and Inference-based Cognitive Behavioral Therapy (I-CBT) offer unique approaches. ERP emphasizes confronting fears and breaking the cycle of compulsions by using principles of inhibitory learning, such as expectancy violation and exposure in various contexts. Meanwhile, I-CBT targets the dysfunctional reasoning behind obsessional doubts, helping patients recognize the irrelevance of these doubts and training them to trust their senses. Researchers are excited because these methods could provide more effective, personalized strategies for managing OCD symptoms beyond the standard treatments.

What evidence suggests that this trial's treatments could be effective for OCD?

This trial will compare Exposure and Response Prevention (ERP) therapy with Inference-based Cognitive Behavioral Therapy (I-CBT) for treating OCD. Research has shown that ERP therapy significantly reduces OCD symptoms and lessens related depression and anxiety. However, some individuals may not fully benefit, and symptoms can return over time. I-CBT, another treatment option in this trial, targets the thinking patterns behind obsessive thoughts. Studies have found it to be as effective as ERP, and many find it easier to follow. I-CBT is particularly useful for those who struggle with traditional ERP. ^{1 2 3 6 7}

Who Is on the Research Team?

Frederick Aardema, PhD

Principal Investigator

Institut universitaire en santé mentale de Montréal

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exposure and Response Prevention (ERP)
• Inference-based Cognitive Behavioral Therapy (I-CBT)

Trial Overview 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.

How Is the Trial Designed?

Group I: Inference-based Cognitive Behavioral Therapy Experimental Treatment 1 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 Prevention Active Control 1 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 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)

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Serious negative consequences (SNC) from exposure and response prevention (ERP) therapy for obsessive-compulsive disorder (OCD) are extremely rare, occurring in only 0.05% of adult clients and 0.01% of youth clients, indicating that ERP is a safe treatment option.

Despite some therapists' concerns, the study found that most therapists are willing to treat harm-related OCD, and improving communication about the safety and rationale of ERP could enhance access to this effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. Schneider, SC., Knott, L., Cepeda, SL., et al.[2020]

In a study of 288 adults with OCD undergoing residential exposure and response prevention (ERP), those who showed greater willingness to experience unpleasant thoughts and feelings reported faster reductions in OCD symptoms during treatment.

This willingness was found to be a significant factor in treatment success, suggesting that embracing discomfort may enhance the effectiveness of ERP for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. Reid, AM., Garner, LE., Van Kirk, N., et al.[2018]

A meta-analysis of 13 trials showed that group cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for obsessive-compulsive disorder (OCD), with a strong pre-post effect size of 1.18.

Group CBT/ERP outperformed waiting list controls and achieved better results than pharmacological treatments in some studies, indicating its efficacy as a psychological intervention for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. Jónsson, H., Hougaard, E.[2018]

Cognitive Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) shows a large effect size (g = 0.74) in reducing OCD symptoms across 36 studies involving 2020 patients, but this effect diminishes with increasing age.

While CBT with ERP is more effective than psychological placebo and pharmacological treatments, its efficacy is influenced by the type of control used in studies and is significantly linked to researcher allegiance, raising concerns about the methodological rigor of the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Reid, JE., Laws, KR., Drummond, L., et al.[2021]

In a study of 377 in-patients with OCD, more frequent therapist-guided exposure and response prevention (ERP) sessions were linked to greater symptom reduction, emphasizing the importance of therapist involvement in treatment.

The effectiveness of self-guided ERP was found to be mediated by increased self-efficacy, suggesting that building patients' confidence can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. Voderholzer, U., Hilbert, S., Fischer, A., et al.[2020]

Exposure and response prevention (ERP) therapy shows a small-to-medium effect size in reducing symptoms for patients with obsessive-compulsive disorder (OCD) and Tourette syndrome (TS), based on a meta-analysis of 18 studies involving 1057 OCD patients and 267 TS patients.

The study suggests that while ERP is effective, combining it with other therapies and developing online ERP services could enhance treatment outcomes, as the exact neurological mechanisms behind its efficacy remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. Yan, J., Cui, L., Wang, M., et al.[2022]

Exposure and response prevention (ERP) has significantly improved the treatment outcomes for obsessive-compulsive disorder (OCD), changing the prognosis from poor to very good over the last 20 years.

Despite its effectiveness, some patients still refuse treatment, drop out, or do not benefit from ERP, indicating that while it is a successful method, there is room for improvement in patient adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychological treatment of obsessive-compulsive disorder. Abramowitz, JS.[2019]

In a study involving 61 participants, both exposure and response prevention (ERP) and cognitive therapy (CT) were found to be equally effective in treating obsessive-compulsive disorder, with no significant differences in how they affected obsessions and compulsions over time.

The research indicated that changes in compulsive behaviors were more predictive of overall treatment success than changes in obsessive thoughts, suggesting that both therapies primarily facilitate change through the reduction of compulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. Anholt, GE., Kempe, P., de Haan, E., et al.[2019]

A study involving 127 participants with OCD found that integrating cognitive therapy with exposure and response prevention (ERP) significantly improved treatment outcomes compared to ERP alone, leading to greater reductions in symptoms and obsessive beliefs.

More patients in the ERP + cognitive therapy group were classified as treatment responders, indicating that combining these approaches can enhance the effectiveness of OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rector, NA., Richter, MA., Katz, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6343408/

Exposure and response prevention for obsessive-compulsive ... [4] The first significant nonpharmacological advance in treatment occurred after Meyer[5] reported that patients' OCD symptoms improved when they were exposed ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517812200453X

The effect of exposure and response prevention therapy on ... In addition, compared with the control group, ERP reduced depression (g = 0.15) and anxiety symptoms (g = 0.23) in patients with OCD. Meta-regression results ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9520065/

The effectiveness of exposure and response prevention ... Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with medication, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834260

Exposure Therapy in Mixed Reality for Obsessive ... In this single-center randomized clinical trial including 36 patients, MERP did not significantly reduce OCD symptom severity compared with an active control ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05780-6

Patient adherence as a predictor of acute and long-term ... Substantial research supports the effectiveness of ERP, yet a notable portion of patients do not fully respond while others experience relapse.

6. deconstructingstigma.org deconstructingstigma.org/guides/erp

What Is ERP Therapy? A Guide to OCD's Leading Treatment ERP therapy is a behavioral therapy that gradually exposes people to situations designed to provoke a person's obsessions in a safe ...

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-03701-z

effects of habituation and expectancy violation on short-term ... This study aimed to identify mechanisms of exposure with response prevention (ERP) that predict short-term outcomes in CBT for obsessive ...