Inference-Based Cognitive Therapy Versus Exposure and Response Prevention for Obsessive-Compulsive Disorder

NCT ID: NCT03677947

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2025-03-31

Brief Summary

Obsessive-compulsive disorder (OCD) is a highly disabling psychiatric illness, characterized by obsessional thoughts that cause patients to perform time-consuming and distressing compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice, which requires patients to face their fears by being exposed to feared stimuli. ERP has been shown to reduce symptoms among those who comply with treatment. However, there is still a significant portion of patients that do not improve, especially those who firmly believe their obsessions are realistic and reasonable (i.e. OCD with Overvalued Ideation (OVI)). Also, a signficant proportion of patients refuse the treatment or drop out during treatment due to the distress provoked by ERP. Even among those that do improve, residual symptoms often remain, or symptoms may reappear after treatment. One evidence-based approach to the treatment of OCD, termed inference-based cognitive therapy (IBCT) has been shown to be as effective as ERP with the potential to overcome some of the limitations of ERP. Since IBCT is a cognitive approach, the treatment does not require exposure to feared stimuli and likely more tolerable for patients with OCD. Also, there is evidence that IBCT is more effective than ERP for those with overvalued ideation, since it directly targets the distorted reasoning that is responsible for the intensity and persistence of the obsession. The current study aims to directly compare ERP with this promising evidence-based cognitive therapy, which is expected to be significantly more effective for those with overvalued ideation, as well as significantly more tolerable with lower rates of treatment refusal, drop-out and higher treatment satisfaction. The project is designed to maximize potential beneficial health outcomes and offer a new evidence-based treatment option for the large proportion of patients unable to benefit from ERP.

Detailed Description

The proposed study is a parallel-group randomized controlled trial developed in accordance with CONSORT quality guidelines.The RCT will compare the outcome of 16 sessions of IBCT compared to 16 sessions of ERP in OCD patients. The principal investigators and independent evaluators will be blind to the random allocation treatment conditions with a randomization ratio of 1:1. Both treatments will be administered by trained therapists on a weekly one-on-one basis over a 16-week period with 6-month follow-up conforming to current thinking on relapse in OCD. Conditions of treatment delivery, duration and monitoring will be equivalent across all groups. Both treatments are manualized and any newly engaged therapists will receive intensive training in one therapy protocol to ensure optimal delivery of each modality.

The objective of the present study is to establish IBCT as a psychological treatment that is as effective as ERP, but significantly more tolerable and generalizable for the high proportion of patients who are unable to benefit from ERP.

The hypotheses are that 1) IBCT is non-inferior to ERP; 2) IBCT is superior to ERP among OCD patients with higher levels of OVI; 3) IBCT has lower rates of treatment refusal and drop-out than ERP; and, 4) IBCT has higher levels of acceptability, tolerability, credibility and satisfaction than ERP.

Conditions

Obsessive-compulsive Disorders and Symptoms; Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inference-based cognitive therapy

The treatment primarily targets the dysfunctional reasoning and overvalued ideas. IBCT does not include exposure, but aims to bring resolution to the initial obsessional doubt or overvalued idea by showing the participant that the obsession is the result of incorrect reasoning.

Group Type: ACTIVE_COMPARATOR

Inference-based cognitive therapy

Intervention Type: OTHER

The treatment primarily targets the dysfunctional reasoning that gives rise to obsessional doubts and overvalued ideas. IBCT does not include exposure in vivo, but instead, aims to bring resolution to the initial obsessional doubt or overvalued idea by showing the participant that the obsession is the result of incorrect reasoning.

Exposure and response prevention

ERP is a treatment developed to help people confront their fears based on the rationale that exposure to feared objects, activities, or situations in a safe environment helps reduce fear and decrease avoidance. During the treatment, patients will engage in these exposures to feared stimuli within and between sessions according to hierarchies developed during the initial evaluation sessions, and refrain from engaging in compulsive behaviour until their anxiety subsides (i.e. ritual prevention).

Group Type: ACTIVE_COMPARATOR

Exposure and response prevention

Intervention Type: BEHAVIORAL

ERP is a treatment developed to help people confront their fears based on the rationale that exposure to feared objects, activities, or situations in a safe environment helps reduce fear and decrease avoidance. During the treatment, participants will engage in these exposures to feared stimuli within and between sessions according to hierarchies developed during the initial evaluation sessions, and refrain from engaging in compulsive behaviour until their anxiety subsides (i.e. ritual prevention). Exercises will consist of both exposure in vivo (i.e. exposure in real life situations) and/or imaginal exposure according to recommendations.

Interventions

Exposure and response prevention

ERP is a treatment developed to help people confront their fears based on the rationale that exposure to feared objects, activities, or situations in a safe environment helps reduce fear and decrease avoidance. During the treatment, participants will engage in these exposures to feared stimuli within and between sessions according to hierarchies developed during the initial evaluation sessions, and refrain from engaging in compulsive behaviour until their anxiety subsides (i.e. ritual prevention). Exercises will consist of both exposure in vivo (i.e. exposure in real life situations) and/or imaginal exposure according to recommendations.

Intervention Type: BEHAVIORAL

Inference-based cognitive therapy

The treatment primarily targets the dysfunctional reasoning that gives rise to obsessional doubts and overvalued ideas. IBCT does not include exposure in vivo, but instead, aims to bring resolution to the initial obsessional doubt or overvalued idea by showing the participant that the obsession is the result of incorrect reasoning.

Intervention Type: OTHER

Other Intervention Names

ERP; IBCT

Eligibility Criteria

Inclusion Criteria

• a primary diagnosis of OCD according to Diagnostical and Statistical Manual, version 5 criteria;
• no change in medication during the 12 weeks before treatment for antidepressants (4 weeks for anxiolytics);
• willingness to keep medication stable while participating in the study;
• no evidence of suicidal intent;
• no evidence of current substance abuse;
• no evidence of current or past schizophrenia, bipolar disorder or organic mental disorder;
• not undergoing a current psychological treatment;
• willingness to undergo active psychological treatment;
• willingness to undergo randomization into treatment modality;
• fluency in English and French.

Exclusion Criteria

• another primary diagnosis than OCD requiring treatment;
• medication not stabilized for 12 weeks;
• medication will change during the participation;
• suicidal intent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Frederick Aardema

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederick Aardema, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Montreal East, Quebec, Canada

Countries

Canada

Other Identifiers

2018-1463

Identifier Type: -

Identifier Source: org_study_id