The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.
The investigators are comparing two different methods for helping Canadian Armed Forces veterans with mild traumatic brain injury (mTBI) manage everyday cognitive difficulties. Cognitive rehabilitation is a type of therapy that helps people with brain injury who have challenges in everyday thinking. The investigators have developed a streamlined version of this type of cognitive rehabilitation therapy that can be done in person or virtually and takes place over a 3-week period. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist or Occupational Therapist to the other group. The investigators want to find out whether the individual therapy is better than providing the usual educational material. The therapy sessions are audio-recorded. At McMaster, the investigators job is to listen to the recordings and making sure the therapists are following the study manual. That includes making notes of what the therapists say or do. What the investigators learn in this study may help veterans with mTBI and cognitive issues affect their abilities to do everyday activities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
55
A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE).
Educational materials, designed to help people with traumatic brain injury manage their everyday cognitive challenges will be provided through Zoom video conferencing software.
McMaster University
Hamilton, Ontario, Canada
Recruitment Rate
The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as total number of participants recruited and retained.
Time frame: 12 months
Adherence to Intervention
Three quarters of participants should complete 80% of the prescribed intervention
Time frame: 12 months
Acceptability of the Intervention
The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM).
Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Acceptability of the Appropriateness
The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM).
Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Acceptability of the Feasibility
The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM).
Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
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