Recruiting

Obsessive-Compulsive Disorder

Sponsor:

Concordia University, Montreal

Code:

NCT03661905

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive therapy

Exposure and Response Prevention

Study Details

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.

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT03661905

Start date

Jan 26, 2019

Status verified date

Feb, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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 measure

  • Incidents of participants that drop-out of treatment [ Time Frame: Week 2, through treatment completion. ]
  • Incidents of participants that refuse treatment [ Time Frame: Baseline, up to week two. ]
  • 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). ]

Central Contacts and Locations

Central contacts

Locations

Concordia University

Recruiting

Montréal, Quebec, Canada, H4B1R6

More Information

Sponsor

Concordia University, Montreal

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Keywords

  • Treatment acceptability
  • Cognitive therapy
  • Anxiety disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Concordia University, Montreal on 2024-02-07.