An interventional study of Cognitive Behavioural Therapy (CBT) and Cognitive Rehabilitation in Mild Traumatic Brain Injury and Functional Neurological Disorder, sponsored by University of British Columbia. Completed at 10 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference
Behavioral: Cognitive Behavioural Therapy (CBT)
11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference
Behavioral: Cognitive Rehabilitation
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.
Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.
Recruitment
\>50% of eligible participants agree to enroll
Time frame: Week 0
Treatment credibility
\>50% of enrolled participants rate the intervention as above midpoint on credibility
Time frame: Week 2
Patient adherence
\>70% of participants attend at least 8 sessions
Time frame: Week 12
Therapists compliance
Therapists cover 95% of essential element content
Time frame: Week 12
Retention
\>80% of randomized participants complete the primary outcome measure immediately post-intervention
Time frame: Week 12
Memory concern
Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\]
Time frame: Week 12
Avoidance
Fear-Avoidance of Memory Loss Scale \[range=5-25; higher scores indicate greater fear and avoidance\]
Time frame: Week 12
Reliance on others
Relative subscale of the Memory Compensation Questionnaire \[range=0-115; higher scores indicate greater dependence on others to remember things\]
Time frame: Week 12
Catastrophizing
Adapted Pain Catastrophizing Scale \[range=0-52, higher scores indicate greater catastrophizing\]
Time frame: 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
Time frame: Week 12
Plan to share: Yes — Upon reasonable request
Supporting information: Study protocol, Icf
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of British Columbia