ClinicalTrials.gg
Active, not recruitingNCT03677947RCT_TOC_16Updated Oct 4, 2024

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

An interventional study of Exposure and response prevention and Inference-based cognitive therapy in Obsessive-compulsive Disorders and Symptoms and Obsessive-Compulsive Disorder, sponsored by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Obsessive-Compulsive Disorder

626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.

This study's planned enrollment of 150 is above the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • another primary diagnosis than OCD requiring treatment;
  • medication not stabilized for 12 weeks;
  • medication will change during the participation;
  • suicidal intent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Inference-based cognitive therapy

  • Active comparator
    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).

    Behavioral: Exposure and response prevention

Interventions

  • BehavioralExposure 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.

    Also known as: ERP

  • OtherInference-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.

    Also known as: IBCT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline measure of obsessive and compulsive symptoms of OCD

  2. 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.

    Time frame: up to 8 weeks

  3. 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.

    Time frame: up to 16 weeks

  4. 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.

    Time frame: change from baseline at 6 months

  5. 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.

    Time frame: baseline measure

  6. 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.

    Time frame: change from baseline at 8 weeks

  7. 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.

    Time frame: change from baseline at 16 weeks

  8. 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.

    Time frame: change from baseline at 6 months

Other outcomes

  1. assessing change in symptoms of obsessive-compulsive disorder and associated personality

    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

  2. assessing change in symptoms of obsessive-compulsive disorder and associated personality

    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

  3. assessing change in symptoms of obsessive-compulsive disorder and associated personality

    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

  4. assessing change in symptoms of obsessive-compulsive disorder and associated personality

    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

  5. assess change in symptoms of depression

    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

  6. assess change in symptoms of depression

    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

  7. assess change in symptoms of depression

    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

  8. assess change in symptoms of depression

    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

  9. assess change in symptoms of depression

    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

  10. assess change in symptoms of anxiety

    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

  11. assess change in symptoms of anxiety

    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

  12. assess change in symptoms of anxiety

    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

  13. assess change in symptoms of anxiety

    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

  14. assess impairment in different domain

    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

  15. assess change in impairment in different domain

    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

  16. assess change in impairment in different domain

    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

  17. measure of health-related quality of life

    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

  18. measure of health-related quality of life

    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

  19. measure of health-related quality of life

    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

  20. assessment of change in inferential confusion due to obsessive-compulsive disorder

    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

  21. assessment of change in inferential confusion due to obsessive-compulsive disorder

    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

  22. assessment of change in inferential confusion due to symptoms of obsessive-compulsive disorder

    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

  23. measure change of obsessive beliefs

    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

  24. measure change of obsessive beliefs

    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

  25. measure change of obsessive beliefs

    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

  26. used to assess change in acceptability and adherence of treatment

    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

  27. used to assess change in acceptability and adherence of treatment

    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

  28. used to assess change in acceptability and adherence of treatment

    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

  29. used to evaluate credibility and expectancy of treatment modality by participant

    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

  30. used to evaluate credibility and expectancy of treatment modality by participant

    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

  31. used to evaluate credibility and expectancy of treatment modality by participant

    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

  32. used to evaluate the treatment satisfaction of the participant

    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

  33. used to evaluate the treatment satisfaction of the participant

    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

  34. used to evaluate the treatment satisfaction of the participant

    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

07

Study locations

1 site
  • Centre de recherche de l'Institut universitaire en santé mentale de Montréal
    Montreal East, Quebec H1N 3V2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03677947
Lead sponsor
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Collaborators
McMaster University
Responsible party
Frederick Aardema (Principal Investigator, Advanced Bionics) — Principal investigator
First posted
Sep 19, 2018
Start date
Sep 1, 2018
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Oct 4, 2024

Study contacts

Frederick Aardema, Ph. D.
principal investigator · Université de Montréal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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