Mild Traumatic Brain InjuryNCT05581810
Rehabilitation for Functional Memory Symptoms After Concussion
A study testing Cognitive Behavioural Therapy (CBT) and Cognitive Rehabilitation in people with Mild Traumatic Brain Injury and Functional Neurological Disorder, run by University of British Columbia at 10 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Functional Neurological Disorder
- What is being tested?
- Cognitive Behavioural Therapy (CBT) and Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesCanada
- Study dates
- 29 Nov 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Urgent and Primary Care Center: North Vancouver
North Vancouver, British Columbia, V7L 1A5
Lion's Gate Hosital
North Vancouver, British Columbia, V7L 2L7
Richmond Hospital
Richmond, British Columbia, V6X 1A2
Back in Motion (Post-Concussion Management Program)
Surrey, British Columbia, V3W 5A8
Mount Saint Joseph's Hospital
Vancouver, British Columbia, V5T 3N4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Lifemark (Post-Concussion Management Program)
Vancouver, British Columbia, V6B 6C1
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
Urgent and Primary Care Center: City Center
Vancouver, British Columbia, V6Z 0A3
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
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.
Read the 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.
- Being tested
- Cognitive Behavioural Therapy (CBT), Cognitive Rehabilitation
- Keywords
- Concussion, Functional Cognitive Disorder
- Medical subject headings
- Brain Concussion, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
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.
Cognitive RehabilitationBehavioural
Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | 11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
| Cognitive Rehabilitation | Active comparator | 11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference Receives: Behavioral: Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
>50% of eligible participants agree to enroll
Measured: Week 0
Treatment credibility
>50% of enrolled participants rate the intervention as above midpoint on credibility
Measured: Week 2
Patient adherence
>70% of participants attend at least 8 sessions
Measured: Week 12
Therapists compliance
Therapists cover 95% of essential element content
Measured: Week 12
Retention
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Measured: Week 12
Memory concern
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]
Measured: Week 12
Secondary outcomes (4)
Avoidance
Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]
Measured: Week 12
Reliance on others
Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things]
Measured: Week 12
Catastrophizing
Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]
Measured: Week 12
Patient Global Impression of Change
Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start29 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Noah Silverberg, University of British Columbia
- Investigators
- Noah Silverberg, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581810
- Sponsor's protocol ID
- H22-00436
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Publications
Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024.
PubMed 39410977
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
- ClinicalTrials.gov ID
- NCT05581810
- Acronym / sponsor ID
- H22-00436
- Keywords
- Concussion, Functional Cognitive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT)11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference |
| Cognitive Rehabilitation | Active comparator | Behavioral: Cognitive Rehabilitation11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy (CBT)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. | Behavioural | Cognitive Behavioural Therapy (CBT) |
| Cognitive RehabilitationTraining and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223. | Behavioural | Cognitive Rehabilitation |
Primary outcome
Recruitment
Time frame: Week 0
>50% of eligible participants agree to enroll
Treatment credibility
Time frame: Week 2
>50% of enrolled participants rate the intervention as above midpoint on credibility
Patient adherence
Time frame: Week 12
>70% of participants attend at least 8 sessions
Therapists compliance
Time frame: Week 12
Therapists cover 95% of essential element content
Retention
Time frame: Week 12
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Memory concern
Time frame: Week 12
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]
4 secondary outcomes
Avoidance
Time frame: Week 12
Reliance on others
Time frame: Week 12
Catastrophizing
Time frame: Week 12
Patient Global Impression of Change
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 39410977Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Silverberg, PhD principal investigator
University of British Columbia
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) and Cognitive Rehabilitation in people with Mild Traumatic Brain Injury and Functional Neurological Disorder, run by University of British Columbia at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.