Rehabilitation for Functional Memory Symptoms After Concussion

Status Active, not recruiting

Clinical 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). 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05581810
Study type	Interventional
Source	University of British Columbia
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 29, 2022
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04372797` - Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)	N/A
Completed	`NCT01903525` - DHA For The Treatment of Pediatric Concussion Related to Sports Injury	Phase 1
Completed	`NCT01847040` - Deployment Related Mild Traumatic Brain Injury (mTBI)
Completed	`NCT03678077` - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Recruiting	`NCT05682677` - Combined Neuromodulation and Cognitive Training for Post-mTBI Depression	N/A
Terminated	`NCT03345550` - OPTIMA-TBI Pilot Study	Phase 2
Completed	`NCT05095012` - RECOVER Clinical Pathway for Pediatric Concussion	N/A
Recruiting	`NCT05886400` - The Effects of Environmental Distractions on SCAT6 Outcomes	N/A
Recruiting	`NCT05262361` - Persistent Post-Concussion Symptoms With Convergence Insufficiency	N/A
Active, not recruiting	`NCT03892291` - Objective Dual-task Turning Measures for Return-to-duty Assessments
Completed	`NCT03688984` - Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury	N/A
Completed	`NCT02057081` - Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI	N/A
Recruiting	`NCT06233851` - t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI
Completed	`NCT02844946` - One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology	N/A
Completed	`NCT04641767` - BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
Recruiting	`NCT06112093` - Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches	N/A
Recruiting	`NCT03819608` - Neuromodulation and Neurorehabilitation for mTBI Plus PTSD	N/A
Withdrawn	`NCT00580918` - Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Completed	`NCT03319966` - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Recruiting	`NCT03846830` - Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.