Cognitive Therapy vs Exposure Therapy for OCD

(RCT_TOC_16 Trial)

Not currently recruiting at 1 trial location

Overseen By Lysandre Bourguignon, Ph.d

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Must be taking: Antidepressants, Anxiolytics

Disqualifiers: Substance abuse, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different therapies for people with obsessive-compulsive disorder (OCD). It compares Exposure and Response Prevention (ERP), which involves directly facing fears, with Inference-Based Cognitive Therapy (IBCT), which focuses on changing thought patterns without confronting fears directly. The goal is to determine which method is more effective and easier for people with OCD, particularly those who strongly believe in their obsessive thoughts. This trial may suit individuals diagnosed with OCD who have been on stable medication and are open to trying a new therapy. Participants should not have other mental health conditions such as schizophrenia or bipolar disorder. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance quality of life.

Will I have to stop taking my current medications?

You don't have to stop taking your current medications, but you need to keep them stable while participating in the study. Your medication should not have changed in the 12 weeks before starting the trial for antidepressants (4 weeks for anxiolytics).

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

Research has shown that exposure and response prevention (ERP) is a well-accepted treatment for obsessive-compulsive disorder (OCD), reducing symptoms more effectively than a placebo or medication. However, some individuals find it distressing, particularly if their OCD involves fears of causing harm, leading them to refuse or discontinue the treatment.

Inference-based cognitive therapy (IBCT), on the other hand, is often easier for many patients to handle. Studies suggest that it does not require directly facing feared objects or situations. Instead, it focuses on changing how a person thinks about their obsessions. This approach can be more comfortable, especially for those who find ERP challenging.

Both treatments are effective, but IBCT might be easier for some individuals to manage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for OCD because they offer distinct approaches compared to traditional options like medication and conventional cognitive-behavioral therapy. Exposure and response prevention (ERP) is unique because it directly confronts fears in a safe environment, encouraging patients to face anxiety-inducing situations and refrain from compulsive behaviors until their anxiety naturally decreases. This method helps reduce fear and avoidance over time. On the other hand, Inference-based cognitive therapy (IBCT) stands out by targeting the dysfunctional reasoning behind obsessions, aiming to resolve the initial doubt or overvalued idea without the need for exposure. This approach offers a fresh perspective by focusing on correcting incorrect reasoning, potentially benefiting those who struggle with traditional exposure techniques.

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

This trial will compare two treatments for obsessive-compulsive disorder (OCD): exposure and response prevention (ERP) and inference-based cognitive therapy (IBCT). Research has shown that ERP, one of the treatments participants may receive, is a well-supported method for reducing OCD symptoms, as well as depression and anxiety. However, some patients find it hard to complete due to its distressing nature.

IBCT, another treatment option in this trial, has been found to be just as effective as ERP, with some additional benefits. Studies suggest that IBCT is particularly helpful for those who strongly believe in their obsessions. It focuses on changing faulty thinking and does not require facing feared situations, which might make it easier for some patients to handle. Additionally, long-term studies have shown that IBCT can lead to lasting improvements in OCD symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Frederick Aardema, Ph. D.

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who are fluent in English or French, have not changed their medication for the past 12 weeks, and do not have a history of substance abuse or certain mental disorders. Participants must be willing to potentially switch treatments and keep medications stable during the study.

Inclusion Criteria

I am willing to be randomly assigned to a treatment group.

I have been diagnosed with OCD based on DSM-5 criteria.

Fluency in English and French

Exclusion Criteria

Medication not stabilized for 12 weeks

Medication will change during the participation

I am being treated for a condition that is not OCD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Inference-Based Cognitive Therapy (IBCT) or Exposure and Response Prevention (ERP) therapy over 16 sessions

16 weeks

16 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exposure and response prevention
• Inference-based cognitive therapy

Trial Overview The study compares two OCD treatments: Inference-based cognitive therapy (IBCT), which challenges distorted reasoning without exposure to fears, versus Exposure and Response Prevention (ERP), which involves facing fears directly. The effectiveness, tolerability, and satisfaction rates will be evaluated.

How Is the Trial Designed?

Group I: Exposure and response prevention Active Control 1 Intervention

ERP is a treatment developed to help people confront their fears based on the rationale that exposure to feared objects, activities, or situations in a safe environment helps reduce fear and decrease avoidance. During the treatment, patients will engage in these exposures to feared stimuli within and between sessions according to hierarchies developed during the initial evaluation sessions, and refrain from engaging in compulsive behaviour until their anxiety subsides (i.e. ritual prevention).

Group II: Inference-based cognitive therapy Active Control 1 Intervention

The treatment primarily targets the dysfunctional reasoning and overvalued ideas. IBCT does not include exposure, but aims to bring resolution to the initial obsessional doubt or overvalued idea by showing the participant that the obsession is the result of incorrect reasoning.

Who Is Running the Clinical Trial?

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Lead Sponsor

Trials

13

Recruited

1,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Citations

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

Exposure and response prevention for obsessive-compulsive ... In this review, we will describe the theoretical underpinnings and elements of ERP, examine the evidence for its effectiveness, and discuss new directions for ...

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. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.973838/full

The effectiveness of exposure and response prevention ... Conclusion: 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6935308/

Exposure and Response Prevention in the Treatment of ... Numerous clinical trials support the efficacy of exposure and response prevention (ERP) for the treatment of obsessive-compulsive disorder (OCD).

6. 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 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/da.23000

Serious negative consequences associated with exposure ... Negative beliefs about the safety and tolerability of ERP are common, especially for harm-related OCD symptoms.