NCT03241056

Brief Summary

A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT) module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets maladaptive beliefs about memory and results show that it is effective at significantly decreasing checking symptoms as compared to a waitlist control. The objectives of the current investigation are to further investigate CBT-C by (1) replicating the pilot results in a larger sample; (2) using an active control condition (treatment as usual) as the comparison condition (3) including a 6-month follow-up, and (4) determining whether the association between maladaptive beliefs about memory at pre-treatment assessment are related to degree of checking symptom reduction following CBT-C. The findings of the study will have theoretical significance in adding to our understanding of the maladaptive belief domains relevant to the development and maintenance of OCD and supporting the cognitive model of compulsive checking. The relevant clinical significance is the further development of an intervention that could improve outcomes in treatment of persons with OCD. The key practical outcome of the research would be to add a stepped care offering to patients with OCD.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

5.6 years

First QC Date

July 27, 2017

Last Update Submit

May 14, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Vancouver Obsessional Compulsive Inventory - checking subscale (change)

    This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.

    Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later

  • Average time spent checking per week (change)

    Participants record their daily time spent checking in daily diary records while in the active phase of the study.

    Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later

  • Vancouver Obsessional Compulsive Inventory - checking subscale

    This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.

    Avarege time spent checking at 6-month follow-up

Secondary Outcomes (4)

  • Beliefs about Memory Inventory (change)

    Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later

  • Beliefs about Memory Inventory

    Beliefs about memory at 6 month follow-up

  • Obsessive Beliefs Questionnaire (change)

    Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later

  • Obsessive Beliefs Questionnaire

    Obsessive beliefs at 6-month follow-up

Study Arms (2)

CBT for Maladaptive Beliefs about Memory

EXPERIMENTAL

Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.

Behavioral: CBT for Maladaptive Beliefs about Memory

Treatment as Usual

ACTIVE COMPARATOR

This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.

Other: Treatment as Usual

Interventions

Treatment as Usual (TAU) during patients' time on our waitlist in our clinic will depend on at what point they have been recruited. It may consist of a 2-session group psychoeducational intervention on anxiety, any medications prescribed by their referring physicians, and/or independent therapy/counseling they may be seeking on the side. TAU for community participants will include any treatments they are currently seeking. Information about participation in such interventions will be collected during the course of the study (at each assessment visit) in order to accurately characterize participants' TAU in the current study.

Treatment as Usual

The novel intervention is a manualized 2-session cognitive behavioural therapy. Agenda elements, including psycho-education, discussion prompts, and homework exercises are standardized across participants. In session 1, participants are taught about the cognitive theory of checking, the research support behind this theory, and how it may apply to their own checking behavior. A homework exercise is introduced and practiced to test out this theory. In session 2, the homework results are reviewed. Further education is shared on the nature of memory and the relationship to checking, and a discussion regarding how this applies to the participant's checking then takes place. A second homework exercise is introduced to test this theory.

CBT for Maladaptive Beliefs about Memory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult over the age of 18 living in the province of Manitoba, Canada.
  • Diagnosis of OCD with clinically significant levels of compulsive checking (i.e., able to meet the diagnostic criteria for OCD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition based solely on checking symptoms. Other OCD symptoms may be present and checking does not need to be the primary symptom.)

You may not qualify if:

  • Active psychosis
  • Active Mania
  • Presence of a substance use disorder that would interfere with participation in the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 7, 2017

Study Start

January 4, 2018

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations