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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | 11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference |
|
| Cognitive Rehabilitation | Active Comparator | 11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | >50% of eligible participants agree to enroll | Week 0 |
| Treatment credibility | >50% of enrolled participants rate the intervention as above midpoint on credibility | Week 2 |
| Patient adherence | >70% of participants attend at least 8 sessions | Week 12 |
| Therapists compliance | Therapists cover 95% of essential element content | Week 12 |
| Retention | >80% of randomized participants complete the primary outcome measure immediately post-intervention | Week 12 |
| Memory concern | Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory] | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Avoidance | Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance] | 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Silverberg, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urgent and Primary Care Center: North Vancouver | North Vancouver | British Columbia | V7L 1A5 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39410977 | Result | 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. |
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Upon reasonable request
12 months after publication
Defined research question approved by the principal investigator
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D003291 | Conversion Disorder |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D000066530 | Neurological Rehabilitation |
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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.
|
| Cognitive Rehabilitation | Behavioral | Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223. |
|
| Week 12 |
| Catastrophizing | Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing] | 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 | Week 12 |
| Lion's Gate Hosital |
| North Vancouver |
| British Columbia |
| V7L 2L7 |
| Canada |
| Richmond Hospital | Richmond | British Columbia | V6X 1A2 | Canada |
| Back in Motion (Post-Concussion Management Program) | Surrey | British Columbia | V3W 5A8 | Canada |
| Mount Saint Joseph's Hospital | Vancouver | British Columbia | V5T 3N4 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Lifemark (Post-Concussion Management Program) | Vancouver | British Columbia | V6B 6C1 | Canada |
| University of British Columbia Hospital | Vancouver | British Columbia | V6T 2B5 | Canada |
| Urgent and Primary Care Center: City Center | Vancouver | British Columbia | V6Z 0A3 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |