Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Obsessive Compulsive Disorder
  • Obsessive-compulsive Disorders and Symptoms
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The RCT will compare the outcome of 16 sessions of Inference Based Cognitive Therapy compared to 16 sessions of Exposure and Response Prevention in Obsessive Compulsive Disorder patients. The 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. Due to COVID-19 participants are given the option to receive the treatment either through face-to-face meetings or by videoconferencing as of April, 2020.Masking: Single (Outcomes Assessor)Masking Description: The independent evaluators will be blind to the random allocation treatment conditions.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 t...

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 is IBCT is non-inferior to ERP; IBCT is superior to ERP among OCD patients with high levels of OVI and IBCT is more tolerable than ERP with lower rates of treatment refusal, drop-out and higher levels of treatment satisfaction in comparison to ERP.

Tracking Information

NCT #
NCT03677947
Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Frederick Aardema, Ph. D. Université de Montréal