Towards Remission and Full Recovery From Obsessive-compulsive Disorder

NCT06318806 | Recruiting DMC

• 1 other identifier: 2024-3633
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  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 (9)

• Vancouver Obsessional Compulsive Inventory (VOCI)

  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

• Beck Depression Inventory (BDI)

  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

• Beck Anxiety Inventory (BAI)

  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

• Inferential Confusion Questionnaire (ICQ)

  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

• Dysfunctional Reasoning Processes Task (DRPT)

  After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment

Study Arms (2)

Exposure and Response Prevention

ACTIVE COMPARATOR

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.

Other: Psychotherapy

Inference-based Cognitive Behavioral Therapy

EXPERIMENTAL

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.

Other: Psychotherapy

Interventions

Psychotherapy OTHER

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

Exposure and Response Prevention; Inference-based Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• willingness to keep medication stable while participating in the study.
• not undergoing a concurrent psychological treatment.
• access to a computer or phone with internet access.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3V2, Canada

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Frederick Aardema, PhD

  Institut universitaire en santé mentale de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick Aardema, PhD

CONTACT

514-662-5116; faardema@gmail.com

Lysandre Bourguignon, Msc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: The study is a single site parallel-group randomized-controlled trial with an active run-in treatment. In the first phase of the trial, participants diagnosed with OCD will receive an active run-in treatment consisting of 18 sessions of ERP. In the second phase, non-remitters will be randomly allocated to another 18 sessions of I-CBT or continued treatment with ERP. Non-remission is operationalized in accordance with validated cut-off points established through international consensus and empirical findings (a score of \>12 on the YBOCS and a CGI-S rating of 3 or higher (mild to extremely ill) after the run-in treatment with ERP). I-CBT and continued ERP will be followed by a 6-month and 12-month follow-up conforming to current thinking on relapse and recovery in OCD. Treatments will be administered by trained therapists on a weekly one-on-one basis via videoconferencing for the duration of one hour.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

CA (1)