Recruiting

Obsessive-Compulsive Disorder

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06318806

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psychotherapy

Study Details

Brief summary:

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

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT06318806

Start date

Jul 1, 2024

Status verified date

Jul, 2024

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Exposure and Response Prevention

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.

experimental: Inference-based Cognitive Behavioral Therapy

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.

Interventions

Psychotherapy

Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.

Primary outcome measure

  • Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2) [ Time Frame: Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up ]
  • Clinical Global Impression Scale (CGI) [ Time Frame: Baseline, change after 9 weeks of treatment, 18 weeks of treatment, change in phase 2 after 9 weeks of treatment, change in phase 2 after 18 weeks of treatment, change after 6-month follow-up, change after 12-month follow-up ]

Central Contacts and Locations

Central contacts

Frederick Aardema, PhD

514-662-5116faardema@gmail.com

Lysandre Bourguignon, Msc

514-251-3400lysandre.bourguignon.cemtl@ssss.gouv.qc.ca

Locations

Institut universitaire en santé mentale de Montréal

Recruiting

Montréal, Quebec, Canada, H1N 3V2

Contacts

Lysandre Bourguignon, Bsc

514.251.4015lysandre.bourguignon.cemtl@ssss.gouv.qc.ca

Frederick Aardema, PhD

514.662.5116frederick.aardema@umontreal.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-07-08.