REhabilitation of MEMory Symptoms After BRain Concussion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversity of British Columbia
About this trial
Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-59
Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria
Concussion occurred between 6 and 36 months before enrollment
Ongoing memory concerns
Disqualifiers
Fail performance validity testing
Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioral therapy
BehavioralCognitive behavioral therapy (CBT) is delivered by a psychologist over 10 individual (1:1) manualized videoconference sessions. The goal of this therapy is for participants to use their memory more normally (i.e., reduce avoidance and safety behaviors) and view memory lapses as less threatening.
Cognitive rehabilitation
BehavioralCognitive compensatory strategy training (CCST), a traditional cognitive rehabilitation intervention, is delivered by a Occupational Therapist over 10 individual (1:1) manualized videoconference sessions. Participants optimize their use of current compensatory strategies and/or learn new ones suited to their needs and lifestyle. The goal is to minimize memory lapses in daily life.
Treatment groups
184 Participants
are divided into 3 treatment groupsGroup A: Cognitive behavioral therapyExperimental treatment 1 intervention
Group B: Cognitive rehabilitationActive comparator 1 intervention
Group C: Waitlist - Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Multifactorial Memory Questionnaire-Satisfaction scale
Measures participants' concern, satisfaction, and overall appraisal of their memory ability. Participants rate their agreement with 18 statements. Total scores range from 0 to 72, with lower total scores indicating worse subjective memory functioning.
Time frame
Week 20Secondary outcomes
1
Fear-Avoidance of Memory Loss Scale
Assesses fears and avoidance behaviors associated with memory decline. Participants rate 24 items on a 5-point scale, where the higher scores indicate greater memory concern and maladaptive coping.
Time frame
Week 1 and week 202
Patient Global Impression of Change scale
Participants rate how much their memory functioning has improved or declined overall since the beginning of the study, on a single item rated on a 7-point scale where the midpoint is no change.
Time frame
Week 203
Work and Social Adjustment Scale
Participants rate how much their condition interferes with their ability to carry out occupational and social activities across 5 items, on a scale from 1-7 where higher scores indicate more difficulty.
Time frame
Week 1 and week 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov