REhabilitation of MEMory Symptoms After BRain Concussion

NCT ID: NCT06956417

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2029-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Concussion, Brain Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive behavioral therapy

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

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.

Cognitive rehabilitation

Group Type ACTIVE_COMPARATOR

Cognitive rehabilitation

Intervention Type BEHAVIORAL

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.

Waitlist - Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive 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.

Intervention Type BEHAVIORAL

Cognitive 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noah Silverberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noah D Silverberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Calgary Brain Injury Program

Calgary, Alberta, Canada

Site Status RECRUITING

Fraser Health Acquired Brain Injury and Concussion Services

Langley, British Columbia, Canada

Site Status RECRUITING

G.F. Strong Adult Concussion Services

Vancouver, British Columbia, Canada

Site Status RECRUITING

Integrated Adult Concussion Program at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

360 Concussion Care Clinic

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

Sunnybrook Traumatic Brain Injury Clinic

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Head Injury Clinic at St. Michael's Hospital

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Hull-Ellis Concussion and Research Clinic at University Health Network

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Canadian Concussion Centre at Toronto Western Hospital

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Noah D Silverberg, PhD

Role: CONTACT

6047341313 ext. 2316

Tasha L Klotz, BA

Role: CONTACT

6047341313 ext. 2316

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chantel Debert

Role: primary

Christina Campbell

Role: backup

William Panenka

Role: primary

Sarah Courtice

Role: primary

604-734-4113

Michel Rathbone

Role: primary

Miles Byworth

Role: backup

Roger Zemek

Role: primary

1-613-668-0360

Matthew Burke

Role: primary

Cindy Hunt

Role: primary

Mark Bayley

Role: primary

Tharshini Chandra

Role: backup

(416) 597-3422 ext. 3645

Carmela Tartaglia

Role: primary

416-603-5483

Artee Srivastava

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024.

Reference Type BACKGROUND
PMID: 39410977 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H24-02486

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.