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

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ClinicalTrials.gov Identifier: NCT03677947
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Frederick Aardema, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

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 large proportion of patients refuse the treatment or drop out during treatment due to the distress provoked by ERP. That leaves at most 3-4 out of 10 people with OCD who benefit from ERP, and even then, residual symptoms often remain, or symptoms eventually 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 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.

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorders and Symptoms Obsessive-Compulsive Disorder Behavioral: Exposure and response prevention Other: Inference-based cognitive therapy Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The RCT will compare the outcome of 16 sessions of Inference Based Cognitive Therapy compared to 16 sessions of Exposure and Response Prevention in Obsessive Compulsive Disorder patients. The independent evaluators will be blind to the random allocation treatment conditions with a randomization ratio of 1:1. Both treatments will be administered by trained therapists on a weekly one-on-one basis over a 16-week period with 6-month follow-up conforming to current thinking on relapse in OCD. Conditions of treatment delivery, duration and monitoring will be equivalent across all groups. Both treatments are manualized and any newly engaged therapists will receive intensive training in one therapy protocol to ensure optimal delivery of each modality.
Masking: Single (Outcomes Assessor)
Masking Description: The independent evaluators will be blind to the random allocation treatment conditions.
Primary Purpose: Treatment
Official Title: Inference-Based Cognitive Therapy Versus Exposure and Response Prevention for Obsessive-Compulsive Disorder: A 16-Session Randomized Controlled Trial
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: IBCT

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
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.
Other Name: ERP




Primary Outcome Measures :
  1. assessment of change in obsessive and compulsive symptoms and severity [ Time Frame: baseline measure of obsessive and compulsive symptoms of OCD ]

    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.


  2. assessment of change in obsessive and compulsive symptoms and severity [ Time Frame: up to 8 weeks ]

    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.


  3. assessment of change in obsessive and compulsive symptoms and severity [ Time Frame: up to 16 weeks ]

    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.


  4. assessment of change in obsessive and compulsive symptoms and severity [ Time Frame: change from baseline at 6 months ]

    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.


  5. establishing baseline level of overvalued ideation [ Time Frame: baseline measure ]
    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.

  6. assess change in level of overvalued ideation [ Time Frame: change from baseline at 8 weeks ]
    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.

  7. assess change in level of overvalued ideation [ Time Frame: change from baseline at 16 weeks ]
    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.

  8. assess change in level of overvalued ideation [ Time Frame: change from baseline at 6 months ]
    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.


Other Outcome Measures:
  1. assessing change in symptoms of obsessive-compulsive disorder and associated personality [ Time Frame: baseline measure ]
    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.

  2. assessing change in symptoms of obsessive-compulsive disorder and associated personality [ Time Frame: change from baseline at 8 weeks ]
    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.

  3. assessing change in symptoms of obsessive-compulsive disorder and associated personality [ Time Frame: change from baseline at 16 weeks ]
    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.

  4. assessing change in symptoms of obsessive-compulsive disorder and associated personality [ Time Frame: change from baseline at 6 months ]
    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.

  5. assess change in symptoms of depression [ Time Frame: baseline diagnosis to provide description of depression symptoms ]
    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.

  6. assess change in symptoms of depression [ Time Frame: change from baseline diagnosis to provide description of depression symptoms at the beginning of the treatment ]
    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.

  7. assess change in symptoms of depression [ Time Frame: change from beginning of the treatment at 8 weeks ]
    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.

  8. assess change in symptoms of depression [ Time Frame: change from beginning of the treatment at 16 weeks ]
    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.

  9. assess change in symptoms of depression [ Time Frame: change from beginning of the treatment at 6 months ]
    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.

  10. assess change in symptoms of anxiety [ Time Frame: baseline measure ]
    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.

  11. assess change in symptoms of anxiety [ Time Frame: change from baseline at 8 weeks ]
    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.

  12. assess change in symptoms of anxiety [ Time Frame: change from baseline at 16 weeks ]
    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.

  13. assess change in symptoms of anxiety [ Time Frame: change from baseline at 6 months ]
    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.

  14. assess impairment in different domain [ Time Frame: baseline measure ]
    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.

  15. assess change in impairment in different domain [ Time Frame: change from baseline at 16 weeks ]
    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.

  16. assess change in impairment in different domain [ Time Frame: change from baseline at 6 months ]
    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.

  17. measure of health-related quality of life [ Time Frame: baseline measure ]

    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.


  18. measure of health-related quality of life [ Time Frame: change from baseline at 16 weeks ]

    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.


  19. measure of health-related quality of life [ Time Frame: change from baseline at 6 months ]

    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.


  20. assessment of change in inferential confusion due to obsessive-compulsive disorder [ Time Frame: baseline measure ]
    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 .

  21. assessment of change in inferential confusion due to obsessive-compulsive disorder [ Time Frame: change from baseline measure at 16 weeks ]
    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 .

  22. assessment of change in inferential confusion due to symptoms of obsessive-compulsive disorder [ Time Frame: change from baseline measure at 6 months ]
    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 .

  23. measure change of obsessive beliefs [ Time Frame: baseline measure ]
    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."

  24. measure change of obsessive beliefs [ Time Frame: change from baseline measure at 16 weeks ]
    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."

  25. measure change of obsessive beliefs [ Time Frame: change from baseline measure at 6 months ]
    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."

  26. used to assess change in acceptability and adherence of treatment [ Time Frame: baseline measure ]
    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.

  27. used to assess change in acceptability and adherence of treatment [ Time Frame: after 8 treatment session ]
    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.

  28. used to assess change in acceptability and adherence of treatment [ Time Frame: after 16 treatment session ]
    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.

  29. used to evaluate credibility and expectancy of treatment modality by participant [ Time Frame: baseline measure ]
    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.

  30. used to evaluate credibility and expectancy of treatment modality by participant [ Time Frame: up to 8 weeks ]
    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.

  31. used to evaluate credibility and expectancy of treatment modality by participant [ Time Frame: up to 16 weeks ]
    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.

  32. used to evaluate the treatment satisfaction of the participant [ Time Frame: baseline measure ]
    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.

  33. used to evaluate the treatment satisfaction of the participant [ Time Frame: up to 8 weeks ]
    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.

  34. used to evaluate the treatment satisfaction of the participant [ Time Frame: up to 16 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677947


Contacts
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Contact: Karine Bergeron, B. Sc. 514-251-4015 ext 3585 kbergeron.iusmm@ssss.gouv.qc.ca
Contact: Aardema Frederick, Ph.D. 514-251-4015 frederick.aardema@umontreal.ca

Locations
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Canada, Quebec
Centre de recherche de l'Institut universitaire en santé mentale de Montréal Recruiting
Montréal-Est, Quebec, Canada, H1N 3V2
Contact: Karine Bergeron, bachelor    514-251-4015 ext 3585    kbergeron.iusmm@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Frederick Aardema, Ph. D. Université de Montréal

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Responsible Party: Frederick Aardema, Principal Investigator, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
ClinicalTrials.gov Identifier: NCT03677947     History of Changes
Other Study ID Numbers: 2018-1463
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frederick Aardema, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal:
overvalued ideation
treatment acceptability
treatment adherence
treatment outcome
treatment resistance
treatment satisfaction
insight
cognitive therapy
inference based cognitive therapy
exposure and response prevention

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders