Cognitive Checking Intervention for Maladaptive Beliefs About Memory
Primary Purpose
Obsessive-Compulsive Disorder
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBT for Maladaptive Beliefs about Memory
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
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
Sites / Locations
- St. Boniface Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT for Maladaptive Beliefs about Memory
Treatment as Usual
Arm Description
Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.
This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.
Outcomes
Primary Outcome Measures
Vancouver Obsessional Compulsive Inventory - checking subscale (change)
This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
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.
Vancouver Obsessional Compulsive Inventory - checking subscale
This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
Secondary Outcome Measures
Beliefs about Memory Inventory (change)
Self-report questionnaire that assesses extent participant believes they have a bad memory.
Beliefs about Memory Inventory
Self-report questionnaire that assesses extent participant believes they have a bad memory.
Obsessive Beliefs Questionnaire (change)
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 Questionnaire
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241056
Brief Title
Cognitive Checking Intervention for Maladaptive Beliefs About Memory
Official Title
Increasing Memory Confidence: A Novel Intervention for Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding used up; recruitment slow.
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT for Maladaptive Beliefs about Memory
Arm Type
Experimental
Arm Description
Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.
Intervention Type
Behavioral
Intervention Name(s)
CBT for Maladaptive Beliefs about Memory
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vancouver Obsessional Compulsive Inventory - checking subscale (change)
Description
This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
Time Frame
Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later
Title
Average time spent checking per week (change)
Description
Participants record their daily time spent checking in daily diary records while in the active phase of the study.
Time Frame
Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later
Title
Vancouver Obsessional Compulsive Inventory - checking subscale
Description
This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
Time Frame
Avarege time spent checking at 6-month follow-up
Secondary Outcome Measure Information:
Title
Beliefs about Memory Inventory (change)
Description
Self-report questionnaire that assesses extent participant believes they have a bad memory.
Time Frame
Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later
Title
Beliefs about Memory Inventory
Description
Self-report questionnaire that assesses extent participant believes they have a bad memory.
Time Frame
Beliefs about memory at 6 month follow-up
Title
Obsessive Beliefs Questionnaire (change)
Description
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.
Time Frame
Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later
Title
Obsessive Beliefs Questionnaire
Description
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.
Time Frame
Obsessive beliefs at 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H2A6
Country
Canada
12. IPD Sharing Statement
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Cognitive Checking Intervention for Maladaptive Beliefs About Memory
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