Towards Remission and Full Recovery From Obsessive-compulsive Disorder (RCT2023)

March 12, 2024 updated by: Frederick Aardema,, Ciusss de L'Est de l'Île de Montréal

Towards Remission and Full Recovery From Obsessive-compulsive Disorder: Investigating the Efficacy of Inference-Based Cognitive-Behavioral Therapy When Standard Treatment Has Failed

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Exposure and Response Prevention (ERP) improves symptoms in a significant proportion of patients, but only a minority reach remission after completing ERP (~40%). Also, ERP is a difficult treatment that requires requires deliberate and prolonged exposure to fearful stimuli and is associated with lower levels of acceptability and tolerability. The current trial aims to overcome these limitations with Inference-Based Cognitive-Behavioral therapy (I-CBT) - a specialized form of Cognitive Behavioral Therapy that does not require provoking anxiety through exposure to fearful stimuli. To meet our objective, the current study consists of a randomized controlled trial preceded by a run-in treatment with ERP with a total of 160 patients diagnosed with OCD. Those that fail to reach remission with the run-in treatment (est. 60%) will be randomly allocated to either 18 sessions of ICBT or continued treatment with ERP. Patients will be diagnosed by standardized semi-structured interviews and treatment outcome will be assessed by gold standard clinician rated measurement of severity of symptoms by independent evaluators. For our first hypothesis we predict that I-CBT is superior to continued ERP among those who have previously failed to reach remission with ERP in terms of: (a) greater improvement on our principal continuous outcome measure of OCD severity at post-treatment and follow-up; (b) clinical status at post-treatment and follow-up (treatment response, remission and relapse). For our second hypothesis we predict that I-CBT is more acceptable and tolerable as compared to continued treatment with ERP for those previously unable to benefit sufficiently from ERP. For our third hypothesis, we predict that I-CBT is associated with more improvement on our secondary measures of outcome, including a) OC symptom dimensions and negative mood states, b) obsessive beliefs and reasoning processes, and c) psychosocial functioning. For our fourth hypothesis, we predict that ERP is associated with a higher frequency of combined treatment refusal and drop-out rates as compared to I-CBT. For our fifth hypothesis, we predict that treatment outcome during ERP and I-CBT is associated with improvements in inferential confusion and feared-self perceptions. The secondary objective of the current proposal is to identify predictors of outcome and to use supervised machine learning to forecast which patients fail to reach remission following initial ERP treatment in order to enable the selection of patients to administer I-CBT as a first-line treatment in the future. Predictors will consist of previously identified risk factors of negative outcome, as well as proposed candidates in the extant literature

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility criteria for participation in the trial includes: (a) a primary diagnosis of OCD according to DSM-5 criteria, b) a score ≥ 18 on the Y-BOCS (c) age ≥ 18; (d) no change in medication during the 8 weeks before treatment for antidepressants (4 weeks for anxiolytics), (e) willingness to keep medication stable while participating in the study, (f) no evidence of a high level of suicidal ideation, suicidal intent or previous suicide attempts, (g) no past or present psychotic or bipolar disorder, (h) no neurocognitive disorder, pervasive developmental disorder or intellectual disability of a severity judged to significantly interfere with treatment and/or requiring treatment first, (i) no evidence of a substance abuse disorder of a severity judged to significantly interfere with treatment and/or requiring treatment first; (i) not undergoing a concurrent psychological treatment, (j) access to a computer or phone with internet access,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exposure and Response Prevention
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: Psychological
Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.
Other Names:
  • Psychotherapy
Experimental: Inference-based Cognitive Behavioral Therapy
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: Psychological
Psychotherapy is a type of treatment that can help individuals experiencing mental health conditions and emotional challenges.
Other Names:
  • Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2)
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
he Yale-Brown Obsessive-Compulsive Scale - 2 is the instrument of choice to assess obsessive compulsive symptoms and severity.
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)
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancouver Obsessional Compulsive Inventory (VOCI)
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
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 and associated personal
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)
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
The Beck Depression Inventory (BDI) is a standard 21-item measure to assess depressive 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
Beck Anxiety Inventory (BAI)
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
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.
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)
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
The ICQ was originally developed in French and is a 30-item questionnaire.
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)
Time Frame: After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
The Dysfunctional Reasoning Processes Task (DRPT) is used to investigate the relationship of inferential confusion with feared self-perceptions and symptoms of OCD.
After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
Fear of Self Questionnaire (FSQ-20)
Time Frame: After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
The Fear of Self Questionnaire (FSQ) is used to measure the potential relevance of fear of self to obsessional compulsive symptoms.
After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
Obsessive Beliefs Questionnaire (OBQ-20)
Time Frame: After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
The Obsessive Beliefs Questionnaire (OBQ-44) is a 44-item measure developed by the Obsessive Compulsive Cognitions Working Group between 1995 and 1998. The OBQ consist in three twinned domains based on the working group consensus (over-responsibility/over-estimation of threat, intolerance of uncertainty/over-importance of thought, control of thoughts/perfectionism).
After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
The Brunnsviken Brief Quality of Life Scale (BBQ) is a 12 item self-report questionnaire that assesses subjective quality of life across six life areas: Leisure, View on Life, Creativity, Learning, Friends and Friendship, and View on Self.
After baseline before treatment, change after 18 weeks of treatment, change in phase 2 after 18 weeks of treatment
Sheehan Disability Scale
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
The Sheehan Disability Scale measures the functional capacity at the professional, social and family level of the participant/patient.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Frederick Aardema, PhD, Institut universitaire en santé mentale de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3633

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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