New treatment approach for 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

This study is testing whether a new therapy called Inference-based Cognitive Behavioral Therapy can help people with obsessive-compulsive disorder feel better compared to the usual treatment they’ve already tried.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ciusss de L'Est de l'Île de Montréal (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06318806 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on improving treatment outcomes for patients with obsessive-compulsive disorder (OCD) by comparing two therapeutic approaches: Exposure and Response Prevention (ERP) and Inference-based Cognitive Behavioral Therapy (I-CBT). The study will involve a randomized controlled trial with 160 patients who have not achieved remission after an initial ERP treatment. Participants will be assessed for OCD severity using standardized measures, and the effectiveness of I-CBT will be evaluated against continued ERP treatment. The goal is to determine if I-CBT offers superior outcomes for those who struggle with traditional ERP methods.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a primary diagnosis of OCD who have not achieved remission after initial ERP treatment.

Not a fit: Patients with severe suicidal ideation, psychotic disorders, or those currently undergoing other psychological treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and acceptable treatment option for patients with OCD who do not respond to standard therapies.

How similar studies have performed: Previous studies have shown promise for I-CBT in treating OCD, suggesting that this approach may be more effective for certain patient subgroups compared to traditional methods.

Eligibility criteria

Inclusion criteria:

1. a primary diagnosis of OCD according to DSM-5 criteria.
2. a score ≥ 18 on the Y-BOCS
3. age ≥ 18.
4. no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics).
5. willingness to keep medication stable while participating in the study.
6. not undergoing a concurrent psychological treatment.
7. access to a computer or phone with internet access.

   Exclusion criteria:
8. evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts.
9. past or present psychotic or bipolar disorder.
10. neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first.
11. substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first.

Where this trial is running

Montreal, Quebec

• Institut universitaire en santé mentale de Montréal — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Frederick Aardema, PhD — Institut universitaire en santé mentale de Montréal
• Study coordinator: Frederick Aardema, PhD

Conditions: Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder,, Treatment outcome, Predictors of Outcome, Exposure and Response Prevention, Inference-based Cognitive Behavioral Therapy