- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241056
Cognitive Checking Intervention for Maladaptive Beliefs About Memory
December 21, 2023 updated by: Gillian Alcolado, University of Manitoba
Increasing Memory Confidence: A Novel Intervention for Obsessive-Compulsive Disorder
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2H2A6
- St. Boniface Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
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Vancouver Obsessional Compulsive Inventory - checking subscale
Time Frame: Avarege time spent checking at 6-month follow-up
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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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Avarege time spent checking at 6-month follow-up
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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
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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
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Obsessive Beliefs Questionnaire
Time Frame: Obsessive beliefs at 6-month follow-up
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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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Obsessive beliefs at 6-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2018
Primary Completion (Actual)
July 28, 2023
Study Completion (Actual)
July 28, 2023
Study Registration Dates
First Submitted
July 27, 2017
First Submitted That Met QC Criteria
August 1, 2017
First Posted (Actual)
August 7, 2017
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2017:142
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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