Obsessive-Compulsive DisorderNCT03661905
Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder
A study testing Cognitive therapy and Exposure and Response Prevention in people with Obsessive-Compulsive Disorder, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive therapy and Exposure and Response Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD
- Ability to read, write, and communicate in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Concordia University
Montreal, Quebec, H4B1R6
About this study
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive therapy, Exposure and Response Prevention
- Keywords
- Treatment acceptability, Cognitive therapy, Anxiety disorders
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive therapyOther
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.
Exposure and Response PreventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Experimental | 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. Receives: Other: Cognitive therapy |
| Behavioural Therapy | Active comparator | 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. Receives: Behavioral: Exposure and Response Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidents of participants that drop-out of treatment
The investigators will keep a record of the number of participants that drop-out of treatment.
Measured: Week 2, through treatment completion.
Incidents of participants that refuse treatment
The investigators will keep a record of the number of participants that refuse the treatment.
Measured: Baseline, up to week two.
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.
Measured: Through study completion (week 3; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).
Secondary outcomes (3)
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.
Measured: Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).
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.
Measured: Through study completion (Baseline; one week post therapy; 6 month follow-up; 12 month follow-up).
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.
Measured: Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start26 Jan 2019
- Primary completionJun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel assignment where one group will receive Cognitive therapy, and the other group will receive ERP.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, McGill University, University of British Columbia, University College London Hospitals
- Responsible party
- Principal investigator, Adam S. Radomsky, Concordia University, Montreal
- Investigators
- Adam S Radomsky, PhD, Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661905
- Sponsor's protocol ID
- 30006258
- Status last verified
- Feb 2024
- First submitted
- 20 Aug 2018
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT03661905
- Acronym / sponsor ID
- 30006258
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Treatment acceptability, Cognitive therapy, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Université de Montréal, McGill University, University of British Columbia, University College London Hospitals
- Study start
- 26 Jan 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm parallel assignment where one group will receive Cognitive therapy, and the other group will receive ERP.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy | Experimental | Other: Cognitive therapyA 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. |
| Behavioural Therapy | Active comparator | Behavioral: Exposure and Response PreventionMethod 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of OCD
- Ability to read, write, and communicate in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive therapyEmpirically-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. | Other | Cognitive Therapy |
| Exposure and Response PreventionExposure 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. | Behavioural | Behavioural Therapy |
Primary outcome
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.
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.
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.
3 secondary outcomes
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam S Radomsky, PhD principal investigator
Concordia University, Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy and Exposure and Response Prevention in people with Obsessive-Compulsive Disorder, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie L Lavoie, BA (514-848-2424 ext. 2199, stefanie.lavoie@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidents of participants that drop-out of treatment (time frame: Week 2, through treatment completion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.