Rehabilitation for Functional Memory Symptoms After Concussion
Primary Purpose
Mild Traumatic Brain Injury, Functional Neurological Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Cognitive Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Concussion, Functional Cognitive Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18-59 years old
- Fluent in English
- Have regular access to the internet
- Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 18 months ago
- Meet diagnostic criteria for Functional Cognitive Disorder
Exclusion Criteria:
- Objective cognitive impairment on neuropsychological testing
- Performance validity test failure
- Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
- Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
- Probable alcohol or drug use disorder
- Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
- Contraindication(s) for MRI
Sites / Locations
- Urgent and Primary Care Center: North VancouverRecruiting
- Lion's Gate HositalRecruiting
- Richmond HospitalRecruiting
- Back in Motion (Post-Concussion Management Program)Recruiting
- Mount Saint Joseph's HospitalRecruiting
- Vancouver General HospitalRecruiting
- Lifemark (Post-Concussion Management Program)Recruiting
- University of British Columbia HospitalRecruiting
- Urgent and Primary Care Center: City CenterRecruiting
- St. Paul's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Behavioural Therapy (CBT)
Cognitive Rehabilitation
Arm Description
11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference
11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference
Outcomes
Primary Outcome Measures
Recruitment
>50% of eligible participants agree to enroll
Treatment credibility
>50% of enrolled participants rate the intervention as above midpoint on credibility
Patient adherence
>70% of participants attend at least 8 sessions
Therapists compliance
Therapists cover 95% of essential element content
Retention
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Memory concern
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]
Secondary Outcome Measures
Avoidance
Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]
Reliance on others
Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things]
Catastrophizing
Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]
Patient Global Impression of Change
Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment
Full Information
NCT ID
NCT05581810
First Posted
September 22, 2022
Last Updated
November 29, 2022
Sponsor
University of British Columbia
Collaborators
Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT05581810
Brief Title
Rehabilitation for Functional Memory Symptoms After Concussion
Official Title
Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Harvard Medical School (HMS and HSDM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the feasibility of novel cognitive behavioural therapy (CBT)-based intervention designed to improve functional memory symptoms after concussion. Participants will be randomized to CBT or an attention-matched control intervention (cognitive rehabilitation). The primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.
Detailed Description
Background: Although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. There are no known effective treatments for this condition. A promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability.
Methods: A pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (CBT)-based treatment program specifically designed to improve persistent memory complaints after concussion. The main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of Functional Cognitive Disorder. Participants will be randomized (1:1) into one of two groups: CBT or cognitive rehabilitation. Individuals in both groups will participate in 11 x 50-minute sessions delivered over Zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist.
Aims: To evaluate the feasibility and potential efficacy of CBT for functional memory symptoms after concussion.
Approach: Prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. The investigators further hypothesize that CBT will be associated with greater reductions in memory concern compared to the control intervention.
Implications: The results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Functional Neurological Disorder
Keywords
Concussion, Functional Cognitive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be blinded to their group assignment and treatment arms, but not to the type of intervention they are receiving. It is not possible to blind study therapists, as they have to administer the therapy.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioural Therapy (CBT)
Arm Type
Experimental
Arm Description
11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference
Arm Title
Cognitive Rehabilitation
Arm Type
Active Comparator
Arm Description
11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
Cognitive behavioural therapy for functional memory symptoms after concussion is delivered by a psychologist over 11 individual (1:1) secure videoconference sessions. The core active ingredients are 1) Behavioural experiments, which acts by phasing out compensatory strategies in order to increase normal memory use and 2) Cognitive reappraisal, which aids in re-interpreting memory lapses in order to reduce reactivity to them.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.
Primary Outcome Measure Information:
Title
Recruitment
Description
>50% of eligible participants agree to enroll
Time Frame
Week 0
Title
Treatment credibility
Description
>50% of enrolled participants rate the intervention as above midpoint on credibility
Time Frame
Week 2
Title
Patient adherence
Description
>70% of participants attend at least 8 sessions
Time Frame
Week 12
Title
Therapists compliance
Description
Therapists cover 95% of essential element content
Time Frame
Week 12
Title
Retention
Description
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Time Frame
Week 12
Title
Memory concern
Description
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Avoidance
Description
Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]
Time Frame
Week 12
Title
Reliance on others
Description
Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things]
Time Frame
Week 12
Title
Catastrophizing
Description
Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]
Time Frame
Week 12
Title
Patient Global Impression of Change
Description
Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years old
Fluent in English
Have regular access to the internet
Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 24 months ago
Meet diagnostic criteria for Functional Cognitive Disorder
Exclusion Criteria:
Performance validity test failure
Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
Probable alcohol or drug use disorder
Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
Contraindication(s) for MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Silverberg, PhD
Phone
604-714-4106
Email
noah.silverberg@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Rioux
Phone
604-809-1608
Email
cnslab@psych.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urgent and Primary Care Center: North Vancouver
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 1A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afshin Khazei
Facility Name
Lion's Gate Hosital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazel Park
Facility Name
Richmond Hospital
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 1A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Shi
Facility Name
Back in Motion (Post-Concussion Management Program)
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3W 5A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley Norris
Facility Name
Mount Saint Joseph's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5T 3N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Scheuermeyer
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Brubacher
Facility Name
Lifemark (Post-Concussion Management Program)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6B 6C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberley Jung
Facility Name
University of British Columbia Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Brubacher
Facility Name
Urgent and Primary Care Center: City Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 0A3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afshin Khazei
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Scheuermeyer
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request
IPD Sharing Time Frame
12 months after publication
IPD Sharing Access Criteria
Defined research question approved by the principal investigator
Learn more about this trial
Rehabilitation for Functional Memory Symptoms After Concussion
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