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Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive therapy
Exposure and Response Prevention
Sponsored by
Concordia University, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Treatment acceptability, Cognitive therapy, Anxiety disorders

Eligibility Criteria

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

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

Sites / Locations

  • Concordia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Therapy

Behavioural Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidents of participants that drop-out of treatment
The investigators will keep a record of the number of participants that drop-out of treatment.
Incidents of participants that refuse treatment
The investigators will keep a record of the number of participants that refuse the treatment.
Treatment and Acceptability Adherence Scale (TAAS; Milosevic, Levy, Alcolado & Radomsky, 2015)
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

The Vancouver Obsessional Compulsive Inventory (VOCI; Thordarson, Radomsky, Rachman, et al., 2004)
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.
Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5; Brown & Barlow, 2014)
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.
The Yale-Brown Obsessive Compulsive Scale (YBOCS; Goodman, Price, Rasmussen, et al., 1989)
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.

Full Information

First Posted
August 20, 2018
Last Updated
July 18, 2022
Sponsor
Concordia University, Montreal
Collaborators
Université de Montréal, McGill University, University of British Columbia, University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03661905
Brief Title
Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder
Official Title
Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concordia University, Montreal
Collaborators
Université de Montréal, McGill University, University of British Columbia, University College London Hospitals

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Treatment acceptability, Cognitive therapy, Anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two-arm parallel assignment where one group will receive Cognitive therapy, and the other group will receive ERP.
Masking
Outcomes Assessor
Masking Description
Intervention assessors will not know which participants have been assigned to the different interventions.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioural Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Intervention Description
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 Measure Information:
Title
Incidents of participants that drop-out of treatment
Description
The investigators will keep a record of the number of participants that drop-out of treatment.
Time Frame
Week 2, through treatment completion.
Title
Incidents of participants that refuse treatment
Description
The investigators will keep a record of the number of participants that refuse the treatment.
Time Frame
Baseline, up to week two.
Title
Treatment and Acceptability Adherence Scale (TAAS; Milosevic, Levy, Alcolado & Radomsky, 2015)
Description
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.
Time Frame
Through study completion (week 3; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).
Secondary Outcome Measure Information:
Title
The Vancouver Obsessional Compulsive Inventory (VOCI; Thordarson, Radomsky, Rachman, et al., 2004)
Description
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.
Time Frame
Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).
Title
Anxiety Disorders Interview Schedule for DSM-5 (ADIS-5; Brown & Barlow, 2014)
Description
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.
Time Frame
Through study completion (Baseline; one week post therapy; 6 month follow-up; 12 month follow-up).
Title
The Yale-Brown Obsessive Compulsive Scale (YBOCS; Goodman, Price, Rasmussen, et al., 1989)
Description
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.
Time Frame
Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie L Lavoie, BA
Phone
514-848-2424
Ext
2199
Email
stefanie.lavoie@concordia.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Adam S Radomsky, PhD
Phone
514-848-2424
Ext
2202
Email
adam.radomsky@concordia.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam S Radomsky, PhD
Organizational Affiliation
Concordia University, Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4B1R6
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder

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