NCT06956417

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jul 2025Apr 2029

First Submitted

Initial submission to the registry

April 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

April 25, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Functional cognitive disorder

Outcome Measures

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.

    Week 20

Secondary Outcomes (3)

  • Fear-Avoidance of Memory Loss Scale

    Week 1 and week 20

  • Patient Global Impression of Change scale

    Week 20

  • Work and Social Adjustment Scale

    Week 1 and week 20

Study Arms (3)

Cognitive behavioral therapy

EXPERIMENTAL
Behavioral: Cognitive behavioral therapy

Cognitive rehabilitation

ACTIVE COMPARATOR
Behavioral: Cognitive rehabilitation

Waitlist - Usual care

NO INTERVENTION

Interventions

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 behavioral therapy

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.

Cognitive rehabilitation

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Fluent in English
  • Stable access to a computer, tablet, or smartphone with internet capability

You may not qualify if:

  • Fail performance validity testing
  • Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Calgary Brain Injury Program

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Fraser Health Acquired Brain Injury and Concussion Services

Langley, British Columbia, V1M 4A6, Canada

RECRUITING

G.F. Strong Adult Concussion Services

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

Integrated Adult Concussion Program at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

NOT YET RECRUITING

360 Concussion Care Clinic

Ottawa, Ontario, K1H 7X7, Canada

NOT YET RECRUITING

Sunnybrook Traumatic Brain Injury Clinic

Toronto, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

Head Injury Clinic at St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Hull-Ellis Concussion and Research Clinic at University Health Network

Toronto, Ontario, M5G 2A2, Canada

NOT YET RECRUITING

Canadian Concussion Centre at Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 39410977BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Cognitive Behavioral TherapyCognitive Training

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Noah D Silverberg, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah D Silverberg, PhD

CONTACT

Tasha L Klotz, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 4, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations