Cognitive Therapy vs Exposure Therapy for OCD

(RCT_TOC_16 Trial)

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Obsessive-compulsive disorder (OCD) is a highly disabling psychiatric illness, characterized by obsessional thoughts that cause patients to perform time-consuming and distressing compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice, which requires patients to face their fears by being exposed to feared stimuli. ERP has been shown to reduce symptoms among those who comply with treatment. However, there is still a significant portion of patients that do not improve, especially those who firmly believe their obsessions are realistic and reasonable (i.e. OCD with Overvalued Ideation (OVI)). Also, a signficant proportion of patients refuse the treatment or drop out during treatment due to the distress provoked by ERP. Even among those that do improve, residual symptoms often remain, or symptoms may reappear after treatment. One evidence-based approach to the treatment of OCD, termed inference-based cognitive therapy (IBCT) has been shown to be as effective as ERP with the potential to overcome some of the limitations of ERP. Since IBCT is a cognitive approach, the treatment does not require exposure to feared stimuli and likely more tolerable for patients with OCD. Also, there is evidence that IBCT is more effective than ERP for those with overvalued ideation, since it directly targets the distorted reasoning that is responsible for the intensity and persistence of the obsession. The current study aims to directly compare ERP with this promising evidence-based cognitive therapy, which is expected to be significantly more effective for those with overvalued ideation, as well as significantly more tolerable with lower rates of treatment refusal, drop-out and higher treatment satisfaction. The project is designed to maximize potential beneficial health outcomes and offer a new evidence-based treatment option for the large proportion of patients unable to benefit from ERP.

Research Team

Frederick Aardema, Ph. D.

Principal Investigator

Université de Montréal

Eligibility Criteria

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.

I am willing to participate in psychological therapy.

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

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

Treatment Details

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.

Participant Groups

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+