Rehabilitation for Functional Memory Symptoms After Concussion

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05581810

Collaborator

Harvard Medical School (HMS and HSDM) (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury Functional Neurological Disorder	Behavioral: Cognitive Behavioural Therapy (CBT) Behavioral: Cognitive Rehabilitation	N/A

Detailed Description

Background: Although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. There are no known effective treatments for this condition. A promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability.

Methods: A pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (CBT)-based treatment program specifically designed to improve persistent memory complaints after concussion. The main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of Functional Cognitive Disorder. Participants will be randomized (1:1) into one of two groups: CBT or cognitive rehabilitation. Individuals in both groups will participate in 11 x 50-minute sessions delivered over Zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist.

Aims: To evaluate the feasibility and potential efficacy of CBT for functional memory symptoms after concussion.

Approach: Prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. The investigators further hypothesize that CBT will be associated with greater reductions in memory concern compared to the control intervention.

Implications: The results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion

Actual Study Start Date :

Nov 29, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioural Therapy (CBT) 11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference	Behavioral: Cognitive Behavioural Therapy (CBT) 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.
Active Comparator: Cognitive Rehabilitation 11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference	Behavioral: Cognitive Rehabilitation Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.

Arm

Intervention/Treatment

Experimental: Cognitive Behavioural Therapy (CBT)

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

Behavioral: Cognitive Behavioural Therapy (CBT)

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.

Active Comparator: Cognitive Rehabilitation

11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference

Behavioral: Cognitive Rehabilitation

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

Outcome Measures

Primary Outcome Measures

Recruitment [Week 0]
>50% of eligible participants agree to enroll
Treatment credibility [Week 2]
>50% of enrolled participants rate the intervention as above midpoint on credibility
Patient adherence [Week 12]
>70% of participants attend at least 8 sessions
Therapists compliance [Week 12]
Therapists cover 95% of essential element content
Retention [Week 12]
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Memory concern [Week 12]
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]

Secondary Outcome Measures

Avoidance [Week 12]
Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]
Reliance on others [Week 12]
Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things]
Catastrophizing [Week 12]
Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]
Patient Global Impression of Change [Week 12]
Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urgent and Primary Care Center: North Vancouver	North Vancouver	British Columbia	Canada	V7L 1A5
2	Lion's Gate Hosital	North Vancouver	British Columbia	Canada	V7L 2L7
3	Richmond Hospital	Richmond	British Columbia	Canada	V6X 1A2
4	Back in Motion (Post-Concussion Management Program)	Surrey	British Columbia	Canada	V3W 5A8
5	Mount Saint Joseph's Hospital	Vancouver	British Columbia	Canada	V5T 3N4
6	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
7	Lifemark (Post-Concussion Management Program)	Vancouver	British Columbia	Canada	V6B 6C1
8	University of British Columbia Hospital	Vancouver	British Columbia	Canada	V6T 2B5
9	Urgent and Primary Care Center: City Center	Vancouver	British Columbia	Canada	V6Z 0A3
10	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6