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Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder

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ClinicalTrials.gov Identifier: NCT03661905
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Université de Montréal
McGill University
University of British Columbia
University College London, UK.
Information provided by (Responsible Party):
Adam S. Radomsky, Concordia University, Montreal

Brief Summary:
Effective treatments for obsessive-compulsive disorder (OCD) usually emphasize a behavioural approach called Exposure and Response Prevention (ERP). In this treatment, patients are encouraged to face their fears repeatedly and for extended periods of time, with the help and support of a caring therapist. Although this is an approach that has been shown to work, many patients find the treatment to be difficult; some even refuse the treatment, or drop out before improvements are seen. The investigators have been working to develop an alternate approach which is just as effective as ERP, but which the investigators think will be much more acceptable to those who seek help for their OCD. This study will compare the traditional behavioural approach, with the newer cognitively-based approach. The investigators expect that the two treatments will both reduce the symptoms and distress of people with OCD, but that this newer cognitive therapy will have fewer people who refuse or drop out of the treatment, and will be rated as more acceptable. This research will have important implications not only for those struggling with OCD, but also for other anxiety-related problems where behavioural approaches are typically recommended, including posttraumatic stress disorder, social anxiety disorder, and other problems.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Other: Cognitive therapy Behavioral: Exposure and Response Prevention Not Applicable

Detailed Description:

Obsessive-Compulsive Disorder (OCD) is a serious and often severe mental disorder and one of the leading causes of disability worldwide. Effective psychological interventions for OCD exist, but the prevailing option (Exposure and Response Prevention; ERP) has changed very little since it was established in the 1960's; moreover, it is associated with unacceptably high numbers of individuals who drop out from, or refuse the treatment altogether. This is largely because ERP is a difficult treatment, wherein individuals face their fears with increasing difficulty over time. Just as with the development from early chemotherapy and HIV agents, which were effective, but associated with serious and often severe side effects, it is now time to enhance the acceptability of psychological treatments for OCD.

A novel cognitive therapy (CT) approach is likely to be just as effective as ERP, but markedly more acceptable to those who need it. Although CT for OCD is as effective as ERP, previously tested CTs have failed to incorporate recent experimental research, novel cognitive targets or enhancements to acceptability. Indeed, the investigators recent work on treatment acceptability promises to increase the number of individuals who can fully and successfully engage with the treatment.

The purpose of this research is to enhance the acceptability of cognitive-behavioural treatments for OCD; the investigators aim to accomplish this via a randomized controlled trial comparing traditional ERP against the investigators' novel CT approach. Although the investigators expect both treatments to be effective, the primary hypothesis is that CT will be significantly more acceptable to participants than ERP; this will be assessed by the relative numbers of treatment refusers and dropouts, as well as by participant ratings of treatment acceptability.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two-arm parallel assignment where one group will receive Cognitive therapy, and the other group will receive ERP.
Masking: Single (Outcomes Assessor)
Masking Description: Intervention assessors will not know which participants have been assigned to the different interventions.
Primary Purpose: Treatment
Official Title: Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder
Actual Study Start Date : January 26, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive Therapy
A modularized, cognitive-behavioural therapy intervention that incorporates evidence gathering and behavioural experiments. Our CT protocols rely heavily on behavioural experiments which are typically targeted and brief exercises designed to permit clients/patients to gather disconfirmatory evidence about their beliefs.
Other: Cognitive therapy
Empirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Twelve treatment sessions include components to foster cognitive (i.e. thinking) and behavioural changes.

Active Comparator: Behavioural Therapy
Method of behavioral therapy and form of exposure and response prevention therapy in which individuals confront their fears and discontinue their escape response. Exposures in this protocol are prolonged and repeated, requiring clients/patients to engage in a series of exposures to feared stimuli (e.g., contaminants, doubts, intrusive thoughts), and to refrain from engaging in compulsive behaviour until their anxiety subsides.
Behavioral: Exposure and Response Prevention
Exposure therapy in which individuals confront their fears and discontinue their escape response. Twelve treatment sessions implementing exposure which is prolonged and repeated, requiring clients/patients to engage in a series of exposures to feared stimuli (e.g., contaminants, doubts, intrusive thoughts), and to refrain from engaging in compulsive behaviour until their anxiety subsides.




Primary Outcome Measures :
  1. Incidents of participants that drop-out of treatment [ Time Frame: Week 2, through treatment completion. ]
    The investigators will keep a record of the number of participants that drop-out of treatment.

  2. Incidents of participants that refuse treatment [ Time Frame: Baseline, up to week two. ]
    The investigators will keep a record of the number of participants that refuse the treatment.

  3. Treatment and Acceptability Adherence Scale (TAAS; Milosevic, Levy, Alcolado & Radomsky, 2015) [ Time Frame: Through study completion (week 3; week 6; one week post therapy; 6 month follow-up; 12 month follow-up). ]
    The TAAS is a validated 10-item self-report questionnaire designed to assess treatment acceptability and anticipated adherence in response to a given treatment for anxiety and related problems. It is intended to be administered to potential treatment recipients after they have received information about the treatment. Items are rated on a 7-point Likert-type scale (1 Disagree strongly; 7 Agree strongly) to assess the degree to which participants agree with a variety of statements about a given treatment. Total scores are obtained by summing across all items after negatively worded items (3, 4, 5, 7, 8 and 10) have been reverse-scored. Scores may range from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated ability to adhere to it.


Secondary Outcome Measures :
  1. The Vancouver Obsessional Compulsive Inventory (VOCI; Thordarson, Radomsky, Rachman, et al., 2004) [ Time Frame: Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up). ]
    The VOCI is a 55-item self-report scale designed to assess obsessive-compulsive symptom severity. It includes six subscales assessing various symptoms associated with OCD: checking; contamination; obsessions; just right; indecisiveness; and hoarding. Items are rated on a 5-point Likert-type scale (0 Not at all; 4 Very much), with higher scores indicating higher symptom severity.

  2. Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5; Brown & Barlow, 2014) [ Time Frame: Through study completion (Baseline; one week post therapy; 6 month follow-up; 12 month follow-up). ]
    A semi structured diagnostic interview for anxiety disorders and selected other problems (e.g., depression, substance-related disorders). It assesses a variety of current and lifetime symptoms associated with anxiety and other (e.g., mood, somatoform, substance abuse, psychotic) disorders, according to DSM-V criteria.

  3. The Yale-Brown Obsessive Compulsive Scale (YBOCS; Goodman, Price, Rasmussen, et al., 1989) [ Time Frame: Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up). ]
    This 10-item clinician-administered validated measure consists of two subscales, which assess the severity of participants' obsessions and compulsions and monitors symptom improvement during treatment. Subscale scores are summed with a range from 0 (no symptoms) to 40 (severe OCD), with a score less than 8 considered as subclinical symptomatology, over 16 as clinically significant symptoms, and over 24 as moderate to severe OCD.



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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:

  • Diagnosis of OCD
  • Ability to read, write, and communicate in English

Exclusion Criteria:

  • Psychosis
  • Diagnosis of bipolar disorder (I or II)
  • Current suicidal ideation/intent
  • Current substance abuse
  • If participants are on medication they must be on a stable dose (i.e. have maintained a consistent dose for at least three months) and agree not to change their medication regimen for the duration of the study

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): NCT03661905


Contacts
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Contact: Stefanie L Lavoie, BA 514-848-2424 ext 2199 stefanie.lavoie@concordia.ca
Contact: Adam S Radomsky, PhD 514-848-2424 ext 2202 adam.radomsky@concordia.ca

Locations
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Canada, Quebec
Concordia University Recruiting
Montréal, Quebec, Canada, H4B1R6
Sponsors and Collaborators
Concordia University, Montreal
Université de Montréal
McGill University
University of British Columbia
University College London, UK.
  Study Documents (Full-Text)

Documents provided by Adam S. Radomsky, Concordia University, Montreal:

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Responsible Party: Adam S. Radomsky, Professor, Concordia University, Montreal
ClinicalTrials.gov Identifier: NCT03661905     History of Changes
Other Study ID Numbers: 30006258
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Adam S. Radomsky, Concordia University, Montreal:
Treatment acceptability
Cognitive therapy
Anxiety disorders
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders