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Behavioural Intervention

Psychotherapy for Obsessive-Compulsive Disorder (RCT2023 Trial)

N/A
Recruiting
Led By Frederick Aardema, PhD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. a primary diagnosis of OCD according to DSM-5 criteria.
2. a score ≥ 18 on the Y-BOCS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial focuses on treating Obsessive-compulsive disorder (OCD) using two main approaches: Exposure and Response Prevention (ERP) and Inference-based Cognitive Behavioral Therapy (I-CBT). While

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Psychotherapy like ERP and I-CBT typically doesn't cause physical side effects but may involve emotional discomfort as patients confront fears. Some might experience increased anxiety or distress temporarily during early stages of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Global Impression Scale (CGI)
Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2)
Secondary study objectives
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
Brunnsviken Brief Quality of Life Scale (BBQ)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Inference-based Cognitive Behavioral TherapyExperimental Treatment1 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 PreventionActive Control1 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.

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Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,519,082 Total Patients Enrolled
4 Trials studying Obsessive-Compulsive Disorder
806 Patients Enrolled for Obsessive-Compulsive Disorder
Ciusss de L'Est de l'Île de MontréalLead Sponsor
77 Previous Clinical Trials
6,177 Total Patients Enrolled
Frederick Aardema, PhDPrincipal InvestigatorInstitut universitaire en santé mentale de Montréal
~107 spots leftby Sep 2029
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