search
Back to results

Inference-Based Cognitive Therapy Versus Exposure and Response Prevention for Obsessive-Compulsive Disorder (RCT_TOC_16)

Primary Purpose

Obsessive-compulsive Disorders and Symptoms, Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exposure and response prevention
Inference-based cognitive therapy
Sponsored by
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-compulsive Disorders and Symptoms focused on measuring overvalued ideation, treatment acceptability, treatment adherence, treatment outcome, treatment resistance, treatment satisfaction, insight, cognitive therapy, inference based cognitive therapy, exposure and response prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de recherche de l'Institut universitaire en santé mentale de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inference-based cognitive therapy

Exposure and response prevention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

assessment of change in obsessive and compulsive symptoms and severity
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
assessment of change in obsessive and compulsive symptoms and severity
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
assessment of change in obsessive and compulsive symptoms and severity
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
assessment of change in obsessive and compulsive symptoms and severity
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
establishing baseline level of overvalued ideation
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
assess change in level of overvalued ideation
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
assess change in level of overvalued ideation
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
assess change in level of overvalued ideation
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2018
Last Updated
August 2, 2023
Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT03677947
Brief Title
Inference-Based Cognitive Therapy Versus Exposure and Response Prevention for Obsessive-Compulsive Disorder
Acronym
RCT_TOC_16
Official Title
Inference-Based Cognitive Therapy Versus Exposure and Response Prevention for Obsessive-Compulsive Disorder: A 16-Session Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorders and Symptoms, Obsessive-Compulsive Disorder
Keywords
overvalued ideation, treatment acceptability, treatment adherence, treatment outcome, treatment resistance, treatment satisfaction, insight, cognitive therapy, inference based cognitive therapy, exposure and response prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The RCT will compare the outcome of 16 sessions of IBCT compared to 16 sessions of ERP in OCD patients. The 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 therapists will receive intensive training in one therapy protocol to ensure optimal delivery of each modality. Due to COVID-19, as of April, 2020, treatment will be delivered to participants by videoconferencing only. To protect the integrity and internal validity of the trial, participants who were recruited before this date and received the majority of treatment sessions in face-to-face physical meetings will be excluded from the principal statistical analyses.
Masking
Outcomes Assessor
Masking Description
The independent evaluators will be blind to the random allocation treatment conditions.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inference-based cognitive therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exposure and response prevention
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exposure and response prevention
Other Intervention Name(s)
ERP
Intervention Description
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
Other
Intervention Name(s)
Inference-based cognitive therapy
Other Intervention Name(s)
IBCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
assessment of change in obsessive and compulsive symptoms and severity
Description
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
Time Frame
baseline measure of obsessive and compulsive symptoms of OCD
Title
assessment of change in obsessive and compulsive symptoms and severity
Description
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
Time Frame
up to 8 weeks
Title
assessment of change in obsessive and compulsive symptoms and severity
Description
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
Time Frame
up to 16 weeks
Title
assessment of change in obsessive and compulsive symptoms and severity
Description
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. People who have a total Y-BOCS score: Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD.
Time Frame
change from baseline at 6 months
Title
establishing baseline level of overvalued ideation
Description
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
Time Frame
baseline measure
Title
assess change in level of overvalued ideation
Description
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
Time Frame
change from baseline at 8 weeks
Title
assess change in level of overvalued ideation
Description
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
Time Frame
change from baseline at 16 weeks
Title
assess change in level of overvalued ideation
Description
The Over-Valued Ideas Scale (OVIS) is an 11-item clinician administered scale assess severity of overvalued ideation. These include how strong obsessive belief; how reasonable the belief is; how weak and strong the belief has fluctuated over the past week; how accurate the belief is; the extent to which others share the same beliefs; how the patient attributes similar or differing beliefs in other people; how effective and important the compulsions are; the extent to which their disorder has caused their obsessive belief; and their degree of resistance toward the belief on a 1 to 10 scale. The average of the 11 items provides an estimate of one's degree of OVI, where higher scores represent greater levels of OVI.
Time Frame
change from baseline at 6 months
Other Pre-specified Outcome Measures:
Title
assessing change in symptoms of obsessive-compulsive disorder and associated personality
Description
The Vancouver Obsessional-Compulsive Inventory (VOCI) is a 55-item self-report measure designed to assess a broad spectrum of OCD symptoms and associated personality characteristics. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), and measure participants' agreement with a series of statements related to obsessions and compulsions (e.g., ''I am often very upset by my unwanted impulses to harm other people''). The VOCI has six component subscales: (a) Checking; (b) Contamination; (c) Obsessions; (d) Hoarding; (e) ''Just Right''; and (f) Indecisiveness.
Time Frame
baseline measure
Title
assessing change in symptoms of obsessive-compulsive disorder and associated personality
Description
The Vancouver Obsessional-Compulsive Inventory (VOCI) is a 55-item self-report measure designed to assess a broad spectrum of OCD symptoms and associated personality characteristics. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), and measure participants' agreement with a series of statements related to obsessions and compulsions (e.g., ''I am often very upset by my unwanted impulses to harm other people''). The VOCI has six component subscales: (a) Checking; (b) Contamination; (c) Obsessions; (d) Hoarding; (e) ''Just Right''; and (f) Indecisiveness.
Time Frame
change from baseline at 8 weeks
Title
assessing change in symptoms of obsessive-compulsive disorder and associated personality
Description
The Vancouver Obsessional-Compulsive Inventory (VOCI) is a 55-item self-report measure designed to assess a broad spectrum of OCD symptoms and associated personality characteristics. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), and measure participants' agreement with a series of statements related to obsessions and compulsions (e.g., ''I am often very upset by my unwanted impulses to harm other people''). The VOCI has six component subscales: (a) Checking; (b) Contamination; (c) Obsessions; (d) Hoarding; (e) ''Just Right''; and (f) Indecisiveness.
Time Frame
change from baseline at 16 weeks
Title
assessing change in symptoms of obsessive-compulsive disorder and associated personality
Description
The Vancouver Obsessional-Compulsive Inventory (VOCI) is a 55-item self-report measure designed to assess a broad spectrum of OCD symptoms and associated personality characteristics. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much), and measure participants' agreement with a series of statements related to obsessions and compulsions (e.g., ''I am often very upset by my unwanted impulses to harm other people''). The VOCI has six component subscales: (a) Checking; (b) Contamination; (c) Obsessions; (d) Hoarding; (e) ''Just Right''; and (f) Indecisiveness.
Time Frame
change from baseline at 6 months
Title
assess change in symptoms of depression
Description
The Beck Depression Inventory, version II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total Beck Depression Inventory, version II score, which can range from 0 to 63.
Time Frame
baseline diagnosis to provide description of depression symptoms
Title
assess change in symptoms of depression
Description
The Beck Depression Inventory, version II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total Beck Depression Inventory, version II score, which can range from 0 to 63.
Time Frame
change from baseline diagnosis to provide description of depression symptoms at the beginning of the treatment
Title
assess change in symptoms of depression
Description
The Beck Depression Inventory, version II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total Beck Depression Inventory, version II score, which can range from 0 to 63.
Time Frame
change from beginning of the treatment at 8 weeks
Title
assess change in symptoms of depression
Description
The Beck Depression Inventory, version II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total Beck Depression Inventory, version II score, which can range from 0 to 63.
Time Frame
change from beginning of the treatment at 16 weeks
Title
assess change in symptoms of depression
Description
The Beck Depression Inventory, version II consists of 21 items assessing symptoms of depression experienced during the past 2 weeks. Each item contains four statements reflecting varying degrees of symptom severity. Respondents are instructed to circle the number (ranging from zero to three, indicating increasing severity) that corresponds with the statement that best describes them. Ratings are summed to calculate a total Beck Depression Inventory, version II score, which can range from 0 to 63.
Time Frame
change from beginning of the treatment at 6 months
Title
assess change in symptoms of anxiety
Description
The Beck Anxiety inventory is a scale of 21 items describe the most typical symptoms of anxiety disorders. It was developed to measure the intensity of anxiety symptoms in clinical populations. It asks respondents to indicate how much they have been affected by each symptom during the last week, on a scale from 0 (Not at all) to 3 (Severely - I could barely stand it). Total scores are the sum of all item scores, and range from 0 to 63; higher scores indicate higher anxiety.
Time Frame
baseline measure
Title
assess change in symptoms of anxiety
Description
The Beck Anxiety inventory is a scale of 21 items describe the most typical symptoms of anxiety disorders. It was developed to measure the intensity of anxiety symptoms in clinical populations. It asks respondents to indicate how much they have been affected by each symptom during the last week, on a scale from 0 (Not at all) to 3 (Severely - I could barely stand it). Total scores are the sum of all item scores, and range from 0 to 63; higher scores indicate higher anxiety.
Time Frame
change from baseline at 8 weeks
Title
assess change in symptoms of anxiety
Description
The Beck Anxiety inventory is a scale of 21 items describe the most typical symptoms of anxiety disorders. It was developed to measure the intensity of anxiety symptoms in clinical populations. It asks respondents to indicate how much they have been affected by each symptom during the last week, on a scale from 0 (Not at all) to 3 (Severely - I could barely stand it). Total scores are the sum of all item scores, and range from 0 to 63; higher scores indicate higher anxiety.
Time Frame
change from baseline at 16 weeks
Title
assess change in symptoms of anxiety
Description
The Beck Anxiety inventory is a scale of 21 items describe the most typical symptoms of anxiety disorders. It was developed to measure the intensity of anxiety symptoms in clinical populations. It asks respondents to indicate how much they have been affected by each symptom during the last week, on a scale from 0 (Not at all) to 3 (Severely - I could barely stand it). Total scores are the sum of all item scores, and range from 0 to 63; higher scores indicate higher anxiety.
Time Frame
change from baseline at 6 months
Title
assess impairment in different domain
Description
The Sheehan Disability Scale is a standard measure of impairment in work, social life and family responsibilities which was a composite of 3 self-rated 10-point (0=none, l-3=mild, 4-6=moderate, 7-9=marked, and 10=extreme) Likert response items to assess work, family, and social functioning during the last month.
Time Frame
baseline measure
Title
assess change in impairment in different domain
Description
The Sheehan Disability Scale is a standard measure of impairment in work, social life and family responsibilities which was a composite of 3 self-rated 10-point (0=none, l-3=mild, 4-6=moderate, 7-9=marked, and 10=extreme) Likert response items to assess work, family, and social functioning during the last month.
Time Frame
change from baseline at 16 weeks
Title
assess change in impairment in different domain
Description
The Sheehan Disability Scale is a standard measure of impairment in work, social life and family responsibilities which was a composite of 3 self-rated 10-point (0=none, l-3=mild, 4-6=moderate, 7-9=marked, and 10=extreme) Likert response items to assess work, family, and social functioning during the last month.
Time Frame
change from baseline at 6 months
Title
measure of health-related quality of life
Description
EuroQol-5dimensions is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5Dimensions consists of a descriptive system and the EQ Value Average Score. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ Value Average Score used as a quantitative measure of health outcome that reflects the participant's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles. The final score is a scale numbered from 0 to 100, where100 means the best health you can imagine and 0 means the worst health you can imagine.
Time Frame
baseline measure
Title
measure of health-related quality of life
Description
EuroQol-5dimensions is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5Dimensions consists of a descriptive system and the EQ Value Average Score. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ Value Average Score records the participant's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles. The final score is a scale numbered from 0 to 100, where100 means the best health you can imagine and 0 means the worst health you can imagine.
Time Frame
change from baseline at 16 weeks
Title
measure of health-related quality of life
Description
EuroQol-5dimensions is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5Dimensions consists of a descriptive system and the EQ Value Average Score. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EuroQuol Value Average Score records the participant's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles. The final score is a scale numbered from 0 to 100, where100 means the best health you can imagine and 0 means the worst health you can imagine.
Time Frame
change from baseline at 6 months
Title
assessment of change in inferential confusion due to obsessive-compulsive disorder
Description
The Inferential Confusion Questionnaire-Expanded Version (ICQ-EV) is a 30-item questionnaire measuring an overreliance on imagination, a distrust of the senses, and a tendency to confuse imagination with reality during reasoning. Like the original version, the expanded version of the ICQ is a highly reliable measure that has been shown to explain a large portion of the variance in symptoms of OCD independent of negative mood states and other cognitive domains. Items are rated on a 6-point scale .
Time Frame
baseline measure
Title
assessment of change in inferential confusion due to obsessive-compulsive disorder
Description
The Inferential Confusion Questionnaire-Expanded Version (ICQ-EV) is a 30-item questionnaire measuring an overreliance on imagination, a distrust of the senses, and a tendency to confuse imagination with reality during reasoning. Like the original version, the expanded version of the ICQ is a highly reliable measure that has been shown to explain a large portion of the variance in symptoms of OCD independent of negative mood states and other cognitive domains. Items are rated on a 6-point scale .
Time Frame
change from baseline measure at 16 weeks
Title
assessment of change in inferential confusion due to symptoms of obsessive-compulsive disorder
Description
The Inferential Confusion Questionnaire-Expanded Version (ICQ-EV) is a 30-item questionnaire measuring an overreliance on imagination, a distrust of the senses, and a tendency to confuse imagination with reality during reasoning. Like the original version, the expanded version of the ICQ is a highly reliable measure that has been shown to explain a large portion of the variance in symptoms of OCD independent of negative mood states and other cognitive domains. Items are rated on a 6-point scale .
Time Frame
change from baseline measure at 6 months
Title
measure change of obsessive beliefs
Description
The obsessive beliefs questionnaire is a 20-item key self report questionnaire measuring change in obsessive beliefs domains. Items are answered on a 7-point Likert-type scale (disagree very much to agree very much) in relation to "what you are like most of the time."
Time Frame
baseline measure
Title
measure change of obsessive beliefs
Description
The obsessive beliefs questionnaire is a 20-item key self report questionnaire measuring change in obsessive beliefs domains. Items are answered on a 7-point Likert-type scale (disagree very much to agree very much) in relation to "what you are like most of the time."
Time Frame
change from baseline measure at 16 weeks
Title
measure change of obsessive beliefs
Description
The obsessive beliefs questionnaire is a 20-item key self report questionnaire measuring change in obsessive beliefs domains. Items are answered on a 7-point Likert-type scale (disagree very much to agree very much) in relation to "what you are like most of the time."
Time Frame
change from baseline measure at 6 months
Title
used to assess change in acceptability and adherence of treatment
Description
The Treatment Acceptability/Adherence Scale (TAAS) will be tested by comparing our indices of tolerability across the two treatments. It is a 10-item scale rated on a 7-point scale and assesses acceptability of and anticipated adherence to a given treatment. Higher scores represent greater acceptability.
Time Frame
baseline measure
Title
used to assess change in acceptability and adherence of treatment
Description
The Treatment Acceptability/Adherence Scale (TAAS) will be tested by comparing our indices of tolerability across the two treatments. It is a 10-item scale rated on a 7-point scale and assesses acceptability of and anticipated adherence to a given treatment. Higher scores represent greater acceptability.
Time Frame
after 8 treatment session
Title
used to assess change in acceptability and adherence of treatment
Description
The Treatment Acceptability/Adherence Scale (TAAS) will be tested by comparing our indices of tolerability across the two treatments. It is a 10-item scale rated on a 7-point scale and assesses acceptability of and anticipated adherence to a given treatment. Higher scores represent greater acceptability.
Time Frame
after 16 treatment session
Title
used to evaluate credibility and expectancy of treatment modality by participant
Description
The Credibility and Expectancy Questionnaire (CEQ) is a 6-item measure divided into two subscales assessing treatment credibility (CEQ-Credibility) and expectancy (CEQ-Expectancy), respectively. The first three CEQ items assess credibility and are rated from 1 to 9 with total possible scores ranging from 3 to 27, where higher scores indicate greater credibility beliefs. The final three CEQ items assess expectancy, with one item rated from 1 to 9, and two items rated from 0% to 100% (values from 1 to 11). We standardized these three items into z scores before summing to create the total Expectancy score. The Expectancy scale scores ranged from -6.72 to 5.51, where higher scores indicate higher expectations.
Time Frame
baseline measure
Title
used to evaluate credibility and expectancy of treatment modality by participant
Description
The Credibility and Expectancy Questionnaire (CEQ) is a 6-item measure divided into two subscales assessing treatment credibility (CEQ-Credibility) and expectancy (CEQ-Expectancy), respectively. The first three CEQ items assess credibility and are rated from 1 to 9 with total possible scores ranging from 3 to 27, where higher scores indicate greater credibility beliefs. The final three CEQ items assess expectancy, with one item rated from 1 to 9, and two items rated from 0% to 100% (values from 1 to 11). We standardized these three items into z scores before summing to create the total Expectancy score. The Expectancy scale scores ranged from -6.72 to 5.51, where higher scores indicate higher expectations.
Time Frame
up to 8 weeks
Title
used to evaluate credibility and expectancy of treatment modality by participant
Description
The Credibility and Expectancy Questionnaire (CEQ) is a 6-item measure divided into two subscales assessing treatment credibility (CEQ-Credibility) and expectancy (CEQ-Expectancy), respectively. The first three CEQ items assess credibility and are rated from 1 to 9 with total possible scores ranging from 3 to 27, where higher scores indicate greater credibility beliefs. The final three CEQ items assess expectancy, with one item rated from 1 to 9, and two items rated from 0% to 100% (values from 1 to 11). We standardized these three items into z scores before summing to create the total Expectancy score. The Expectancy scale scores ranged from -6.72 to 5.51, where higher scores indicate higher expectations.
Time Frame
up to 16 weeks
Title
used to evaluate the treatment satisfaction of the participant
Description
The Evaluation of Treatment Questionnaire is a 19-item subjective measure assessing treatment satisfaction. It is a qualitative and quantitative questionnaire. The first two items assess how far therapy help, their importance and the satisfaction. The second part rate what the participant think about the therapy in a 1 to 10 scale. The third part assess what participant feel about the therapy on different scale. Finally, the last part rate satisfaction, preoccupation, stress and what the less like about the therapy.
Time Frame
baseline measure
Title
used to evaluate the treatment satisfaction of the participant
Description
The Evaluation of Treatment Questionnaire is a 19-item subjective measure assessing treatment satisfaction. It is a qualitative and quantitative questionnaire. The first two items assess how far therapy help, their importance and the satisfaction of the participant. The second part rate what the participant think about the therapy in a 1 to 10 scale. The third part assess what participant feel about the therapy on different scale. Finally, the last part rate satisfaction, preoccupation, stress and what the participant less like about the therapy.
Time Frame
up to 8 weeks
Title
used to evaluate the treatment satisfaction of the participant
Description
The Evaluation of Treatment Questionnaire is a 19-item subjective measure assessing treatment satisfaction. It is a qualitative and quantitative questionnaire. The first two items assess how far therapy help, their importance and the satisfaction. The second part rate what the participant think about the therapy in a 1 to 10 scale. The third part assess what participant feel about the therapy on different scale. Finally, the last part rate satisfaction, preoccupation, stress and what the less like about the therapy.
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederick Aardema, Ph.D.
Phone
514-662-5116
Email
frederick.aardema@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lysandre Bourguignon, Ph.d
Phone
514-251-4015
Ext
3585
Email
lysandre.bourguignon.cemtl@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Aardema, Ph. D.
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
City
Montréal-Est
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lysandre Bourguignon, bachelor
Phone
514-251-4015
Ext
3585
Email
lysandre.bourguignon.cemtl@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs