Cognitive Behavioral Therapy for Concussion

(REMEMBR Trial)

Recruiting at 8 trial locations

Overseen By Tasha L Klotz, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Psychiatric, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

184 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if your medication could fully explain your memory symptoms, you might not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Concussion?

Research shows that cognitive rehabilitation, a key part of the treatment, is effective in improving cognitive functions and mood in people with traumatic brain injuries. This suggests it could help those with concussions too. ^{1 2 3 4 5}

Is cognitive behavioral therapy safe for treating concussions?

Cognitive behavioral therapy and cognitive rehabilitation have been used safely in treating individuals with traumatic brain injuries, including concussions, to help improve cognitive functions and mood. There is no specific mention of safety concerns in the research, suggesting it is generally considered safe for humans. ^{1 3 5 6 7}

How does cognitive behavioral therapy differ from other treatments for concussion?

Cognitive behavioral therapy (CBT) for concussion is unique because it focuses on addressing the psychological and emotional aspects of recovery, which are often overlooked in traditional treatments that primarily target physical symptoms. By combining CBT with cognitive rehabilitation, this approach aims to improve mood, increase awareness of injury-related deficits, and enhance day-to-day functioning, offering a more comprehensive recovery strategy. ^{1 4 8 9 10}

What is the purpose of this trial?

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.

Research Team

Noah D Silverberg, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for individuals aged 18-59 who have had a concussion between 6 and 36 months ago, are experiencing ongoing memory issues, speak English fluently, and have stable internet access. It's not for those with other psychiatric or neurological disorders that could explain their memory symptoms.

Inclusion Criteria

Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria

Ongoing memory concerns

Fluent in English

Exclusion Criteria

Fail performance validity testing

I have a mental or brain disorder, or I'm taking medication that could explain my memory issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cognitive behavioral therapy (CBT), cognitive compensatory strategy training (CCST), or usual care over a 20-week period

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive behavioral therapy
• Cognitive rehabilitation

Trial Overview The study compares two treatments to improve memory after a concussion: traditional cognitive rehabilitation and a new type of cognitive-behavioral therapy (CBT). Participants will receive one of these interventions to see which is more effective.

Participant Groups

Group I: Cognitive behavioral therapy Experimental Treatment 1 Intervention

Group II: Waitlist - Usual care Active Control 1 Intervention

Group III: Cognitive rehabilitation Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

Cognitive rehabilitation interventions are effective treatments for individuals with traumatic brain injury (TBI), helping to improve cognitive functions, emotional well-being, and overall daily functioning.

These interventions not only enhance awareness of injury-related deficits but also promote community involvement and reduce the risk of secondary disabilities, highlighting their comprehensive role in recovery after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role and impact of cognitive rehabilitation. Dams-O'Connor, K., Gordon, WA.[2022]

The largest randomized controlled trial on rehabilitation after traumatic brain injury (TBI) shows that both cognitive and functional rehabilitation methods are effective, providing empirical support for their use in recovery.

Each type of intervention (cognitive and functional) has distinct advantages for specific subpopulations of TBI patients, highlighting the need for tailored rehabilitation approaches in occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus functional approaches to rehabilitation after traumatic brain injury: commentary on a randomized controlled trial. Giles, GM.[2019]

A systematic review of 112 studies on cognitive rehabilitation for traumatic brain injury (TBI) and stroke found strong evidence supporting interventions for attention, memory, social communication skills, and executive function, indicating effective treatment options for cognitive disabilities.

The review also highlighted the effectiveness of specific interventions for visuospatial rehabilitation after right hemisphere stroke and for addressing aphasia and apraxia after left hemisphere stroke, providing a solid foundation for evidence-based rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Cicerone, KD., Langenbahn, DM., Braden, C., et al.[2022]

In a 3-month randomized controlled trial involving 461 Veterans with mild traumatic brain injury, the Concussion Coach app significantly reduced postconcussive symptom severity compared to Treatment-as-Usual, with an odds ratio of 1.29.

The app also improved self-efficacy in managing symptoms, which was linked to further reductions in both symptom severity and psychological distress, indicating that enhancing self-management skills is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion coach for postconcussive symptoms: A randomized, controlled trial of a smartphone application with Afghanistan and Iraq war Veterans. Belanger, HG., Toyinbo, P., Barrett, B., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) significantly reduced depression symptoms in individuals with traumatic brain injury (TBI) after an 8-week intervention, with medium to large effect sizes observed across all depression measures.

Participants also reported reduced pain intensity and increased energy levels following MBCT, highlighting its potential benefits beyond just alleviating depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. Bédard, M., Felteau, M., Marshall, S., et al.[2022]

Cognitive Behavioral Therapy (CBT) has been found effective in reducing external aggressive behaviors in individuals with acquired brain injury (ABI), based on a systematic review of seven studies, including one randomized controlled trial and five pre-post trials.

However, CBT did not significantly impact internal feelings of anger, suggesting that while it helps manage outward aggression, it may not address the underlying emotional issues, indicating a need for further research with control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for aggression among individuals with moderate to severe acquired brain injury: a systematic review and meta-analysis. Iruthayarajah, J., Alibrahim, F., Mehta, S., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Role and impact of cognitive rehabilitation. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of traumatic brain injury rehabilitation: interventions of QEEG-guided biofeedback, computers, strategies, and medications. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive versus functional approaches to rehabilitation after traumatic brain injury: commentary on a randomized controlled trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Rehabilitation After Traumatic Brain Injury: A Reference for Occupational Therapists. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Concussion coach for postconcussive symptoms: A randomized, controlled trial of a smartphone application with Afghanistan and Iraq war Veterans. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Description of an early cognitive behavioral intervention (UPFRONT-intervention) following mild traumatic brain injury to prevent persistent complaints and facilitate return to work. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: benefits in reducing depression following a traumatic brain injury. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for aggression among individuals with moderate to severe acquired brain injury: a systematic review and meta-analysis. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy and persistent post-concussional symptoms: integrating conceptual issues and practical aspects in treatment. [2018]