Symptom-Targeted Rehabilitation for Concussion

Not Applicable

Completed

• Conditions: Mild Traumatic Brain Injury
• Interventions: Behavioral: Cognitive Rehabilitation; Other: Education

• Registration Number: NCT05520710
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-30
• Study Start: 2023-01-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Is a community-dwelling Canadian Armed Forces veteran.
• Is age 18 years or older.
• Self-identifies as a fluent English speaker.
• Has no previous history of neurological disorder affecting cognition, by self-report.
• Is able to participate in rehabilitation for 4 weeks: 3 weeks of treatment + baseline + outcome assessment, with potential rescheduling for missed sessions.
• Is not actively participating in cognitive rehabilitation directed by a registered health professional (e.g., speech-language pathologist or occupational therapist).
• Has access to an electronic device with Zoom video platform capacity and internet access.

Exclusion Criteria

• A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
• Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapy Group	Cognitive Rehabilitation	The Therapy Group will receive 6-10 individual sessions of 30-60 minutes each, delivered by a trained Occupational Therapist or Speech-Language Pathologist. The therapy will be delivered over a 4-week timeframe, with the total number of sessions per participant depending on the number of sessions needed to achieve their treatment targets. Each participant in the Therapy Group will identify three cognitive targets for treatment. Progress in reaching those targets will be documented using Goal Attainment Scaling (GAS)
Educational Group	Education	The education group will receive information about self-management of cognitive symptoms at the time of randomization, a common intervention for adults with mild Traumatic Brain Injury.

Primary Outcome Measures

Name	Time	Method
Adherence to Intervention	12 months	Three quarters of participants should complete 80% of the prescribed intervention
Recruitment Rate	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of the Intervention	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.	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).
Acceptability of the Appropriateness	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.	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).
Acceptability of the Feasibility	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.	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).

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada