Rehabilitation for Functional Memory Symptoms After Concussion

NCT05581810 | Completed

• 1 other identifier: H22-00436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

This study aims to evaluate the feasibility of novel cognitive behavioural therapy (CBT)-based intervention designed to improve functional memory symptoms after concussion. Participants will be randomized to CBT or an attention-matched control intervention (cognitive rehabilitation). The primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.

Conditions

Mild Traumatic Brain Injury; Functional Neurological Disorder

Keywords

Concussion; Functional Cognitive Disorder

Outcome Measures

Primary Outcomes (6)

• Recruitment

  \>50% of eligible participants agree to enroll

  Week 0

• Treatment credibility

  \>50% of enrolled participants rate the intervention as above midpoint on credibility

  Week 2

• Patient adherence

  \>70% of participants attend at least 8 sessions

  Week 12

• Therapists compliance

  Therapists cover 95% of essential element content

  Week 12

• Retention

  \>80% of randomized participants complete the primary outcome measure immediately post-intervention

  Week 12

• Memory concern

  Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\]

  Week 12

Secondary Outcomes (4)

• Avoidance

  Week 12

• Reliance on others

  Week 12

• Catastrophizing

  Week 12

• Patient Global Impression of Change

  Week 12

Study Arms (2)

Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL

11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference

Behavioral: Cognitive Behavioural Therapy (CBT)

Cognitive Rehabilitation

ACTIVE COMPARATOR

11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference

Behavioral: Cognitive Rehabilitation

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

Cognitive behavioural therapy for functional memory symptoms after concussion is delivered by a psychologist over 11 individual (1:1) secure videoconference sessions. The core active ingredients are 1) Behavioural experiments, which acts by phasing out compensatory strategies in order to increase normal memory use and 2) Cognitive reappraisal, which aids in re-interpreting memory lapses in order to reduce reactivity to them.

Cognitive Behavioural Therapy (CBT)

Cognitive Rehabilitation BEHAVIORAL

Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.

Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• Fluent in English
• Have regular access to the internet
• Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 24 months ago
• Meet diagnostic criteria for Functional Cognitive Disorder

You may not qualify if:

• Performance validity test failure
• Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
• Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
• Probable alcohol or drug use disorder
• Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
• Contraindication(s) for MRI

Sponsors & Collaborators

• University of British Columbia: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (10)

Urgent and Primary Care Center: North Vancouver

North Vancouver, British Columbia, V7L 1A5, Canada

Location

Lion's Gate Hosital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Richmond Hospital

Richmond, British Columbia, V6X 1A2, Canada

Location

Back in Motion (Post-Concussion Management Program)

Surrey, British Columbia, V3W 5A8, Canada

Location

Mount Saint Joseph's Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Lifemark (Post-Concussion Management Program)

Vancouver, British Columbia, V6B 6C1, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Urgent and Primary Care Center: City Center

Vancouver, British Columbia, V6Z 0A3, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

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: 39410977 RESULT

MeSH Terms

Conditions

Brain Concussion; Conversion Disorder

Interventions

Cognitive Behavioral Therapy; Cognitive Training

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Noah Silverberg, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to their group assignment and treatment arms, but not to the type of intervention they are receiving. It is not possible to blind study therapists, as they have to administer the therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 17, 2022
• Study Start: November 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months after publication
• Access Criteria: Defined research question approved by the principal investigator

Locations

CA (10)