Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder

NCT ID: NCT03661905

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-26
• Study Completion Date: 2024-06-30

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Exposure and Response Prevention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: collaborator

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Adam S. Radomsky

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam S Radomsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Locations

Concordia University

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stefanie L Lavoie, BA

Role: CONTACT

stefanie.lavoie@concordia.ca

514-848-2424 ext. 2199

Adam S Radomsky, PhD

Role: CONTACT

adam.radomsky@concordia.ca

514-848-2424 ext. 2202

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

30006258

Identifier Type: -

Identifier Source: org_study_id