Concussion, Brain, Mild Traumatic Brain Injury
Conditions
Keywords
Functional cognitive disorder
Brief summary
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.
Detailed description
The primary research aims of this study are to determine whether cognitive behavioral therapy (CBT) and cognitive compensatory strategy training (CCST) improves subjective memory functioning compared to usual care, and to compare the effectiveness of CBT and CCST. This study is a multisite three-armed randomized control trial (RCT) that will randomize adults with persistent memory symptoms following concussion to CBT, CCST, or a covert waitlist condition (2:2:1). Participants will be blinded to the other arms of the study and the study hypotheses.
Interventions
BEHAVIORALCognitive behavioral therapy
Cognitive 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.
BEHAVIORALCognitive rehabilitation
Cognitive 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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-59 2. Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria 3. Concussion occurred between 6 and 36 months before enrollment 4. Ongoing memory concerns 5. Fluent in English 6. Stable access to a computer, tablet, or smartphone with internet capability
Exclusion criteria
1. Fail performance validity testing 2. Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multifactorial Memory Questionnaire-Satisfaction scale | Week 20 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear-Avoidance of Memory Loss Scale | Week 1 and week 20 | 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. |
| Patient Global Impression of Change scale | Week 20 | 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. |
| Work and Social Adjustment Scale | Week 1 and week 20 | 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. |
Countries
Canada
Contacts
CONTACTNoah D Silverberg, PhD
CONTACTTasha L Klotz, BA
PRINCIPAL_INVESTIGATORNoah D Silverberg, PhD
University of British Columbia
Outcome results
None listed