Towards Remission and Full Recovery From Obsessive-compulsive Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a primary diagnosis of OCD according to DSM-5 criteria.

a score ≥ 18 on the Y-BOCS

age ≥ 18.

no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics).

Disqualifiers

evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts.

past or present psychotic or bipolar disorder.

neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first.

substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychotherapy

    Other intervention

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Exposure and Response PreventionActive comparator 1 intervention
Group B: Inference-based Cognitive Behavioral TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2)

he Yale-Brown Obsessive-Compulsive Scale - 2 is the instrument of choice to assess obsessive compulsive symptoms and severity. Total scores on the measure range from 0 to 40 with higher scores indicating more severe symptoms.

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
2

Clinical Global Impression Scale (CGI)

The clinical global impression rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Scores on the measure range from 1 to 7 with higher scores indicating more severe symptoms.

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

Secondary outcomes

1

Vancouver Obsessional Compulsive Inventory (VOCI)

The Vancouver Obsessional Compulsive Inventory (VOCI) to assess a broad spectrum of OCD symptoms and associated personality characteristics.It is a 55-item self-report measure to assess a broad spectrum of OCD symptoms. Total scores on the measure range from 0 to 220 with higher scores indicating more severe symptoms.

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
2

Beck Depression Inventory (BDI)

The Beck Depression Inventory (BDI) is a standard 21-item measure to assess depressive symptoms.. Total scores on the measure range from 0 to 63 with higher scores indicating more severe symptoms.

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
3

Beck Anxiety Inventory (BAI)

The Beck Anxiety Inventory (BAI) is a standard 21-item anxiety symptom checklist rating anxiety symptom intensity for the last week on a 0-3 scale. Total scores on the measure range from 0 to 63 with higher scores indicating more severe symptoms.

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
4

Inferential Confusion Questionnaire (ICQ)

The ICQ is a 30-item questionnaire measuring dysfunctional reasoning processes. Total scores on the measure range from 0 to 180 with higher scores indicating higher levels of dysfunctional reasoning.

Time frame
After baseline before treatment, 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 treatmen

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator