Enhancing the Acceptability of Psychological Treatments for Obsessive-compulsive Disorder

NCT03661905 | Recruiting

• 1 other identifier: 30006258
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Treatment acceptability; Cognitive therapy; Anxiety disorders

Outcome Measures

Primary Outcomes (3)

• Incidents of participants that drop-out of treatment

  The investigators will keep a record of the number of participants that drop-out of treatment.

  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.

  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.

  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)

  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)

  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)

  Through study completion (Baseline; week 6; one week post therapy; 6 month follow-up; 12 month follow-up).

Study Arms (2)

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.

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.

Behavioral: Exposure and Response Prevention

Interventions

Cognitive therapy 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.

Cognitive Therapy

Exposure and Response Prevention 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.

Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Université de Montréal: collaborator
• McGill University: collaborator
• University of British Columbia: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

Concordia University

Montreal, Quebec, H4B1R6, Canada

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam S Radomsky, PhD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie L Lavoie, BA

CONTACT

514-848-2424; stefanie.lavoie@concordia.ca

Adam S Radomsky, PhD

CONTACT

514-848-2424; adam.radomsky@concordia.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Intervention assessors will not know which participants have been assigned to the different interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A two-arm parallel assignment where one group will receive Cognitive therapy, and the other group will receive ERP.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 7, 2018
• Study Start: January 26, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)