Cognitive Checking Intervention for Maladaptive Beliefs About Memory
Increasing Memory Confidence: A Novel Intervention for Obsessive-Compulsive Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
- St. Boniface Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- Active psychosis
- Active Mania
- Presence of a substance use disorder that would interfere with participation in the treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: CBT for Maladaptive Beliefs about Memory
Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.
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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.
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Active Comparator: Treatment as Usual
This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vancouver Obsessional Compulsive Inventory - checking subscale (change)
Time Frame: Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later
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This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
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Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later
|
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Average time spent checking per week (change)
Time Frame: Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later
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Participants record their daily time spent checking in daily diary records while in the active phase of the study.
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Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later
|
|
Vancouver Obsessional Compulsive Inventory - checking subscale
Time Frame: Avarege time spent checking at 6-month follow-up
|
This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
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Avarege time spent checking at 6-month follow-up
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beliefs about Memory Inventory (change)
Time Frame: Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later
|
Self-report questionnaire that assesses extent participant believes they have a bad memory.
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Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later
|
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Beliefs about Memory Inventory
Time Frame: Beliefs about memory at 6 month follow-up
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Self-report questionnaire that assesses extent participant believes they have a bad memory.
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Beliefs about memory at 6 month follow-up
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Obsessive Beliefs Questionnaire (change)
Time Frame: Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later
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Self-report questionnaire that assesses maladaptive belief domains known to be related to checking.
The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.
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Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later
|
|
Obsessive Beliefs Questionnaire
Time Frame: Obsessive beliefs at 6-month follow-up
|
Self-report questionnaire that assesses maladaptive belief domains known to be related to checking.
The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.
|
Obsessive beliefs at 6-month follow-up
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- H2017:142
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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