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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two therapies for individuals with memory problems following a concussion. One group will undergo cognitive behavioral therapy, which targets negative thinking and behaviors, while another group will engage in cognitive rehabilitation, focusing on enhancing memory skills. A waitlist group will receive usual care. Individuals who experienced a concussion 6 to 36 months ago and continue to have memory concerns may be suitable for this study. As an unphased trial, this study provides a unique opportunity to advance the understanding of effective treatments for memory issues post-concussion.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive behavioral therapy (CBT) is generally safe for individuals with mild traumatic brain injuries, such as concussions. Studies have found that CBT can enhance mental health and quality of life. One study, in particular, found that starting CBT soon after a concussion improved recovery by enhancing sleep and reducing anxiety. This indicates that CBT is not only safe but also beneficial for those with memory issues following a concussion.

Similarly, cognitive rehabilitation, another method for addressing memory problems, has been shown to improve memory function. However, there is less detailed information about its safety compared to CBT. Since the trial aims to compare CBT and cognitive rehabilitation, both treatments appear to be safe options for managing memory problems after a concussion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for concussion because they focus on addressing cognitive and emotional challenges rather than just physical symptoms. Cognitive behavioral therapy (CBT) is unique because it helps patients manage the psychological aspects of concussion, such as anxiety and mood changes, through structured sessions that modify thought patterns. On the other hand, cognitive rehabilitation targets specific cognitive deficits like memory and attention through tailored exercises. Unlike traditional rest and medication, these approaches aim to empower patients to regain control over their mental and cognitive health, potentially speeding up recovery and improving overall well-being.

What evidence suggests that this trial's treatments could be effective for improving memory after concussion?

Studies have shown that cognitive behavioral therapy (CBT), one of the treatments in this trial, holds promise for treating ongoing symptoms after a concussion. Research indicates that CBT can improve memory by altering unhelpful thoughts and behaviors related to the injury. One study found CBT to be the most researched and effective psychological treatment for ongoing concussion symptoms. Another study found CBT improved mental well-being and quality of life in people with mild brain injuries. Overall, CBT helps people manage their symptoms better after concussions. This trial will compare CBT with cognitive rehabilitation, another treatment option under study, to evaluate their effectiveness in managing concussion symptoms. ^{2 4 6 7 8}

Who Is on the Research Team?

Noah D Silverberg, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cognitive behavioral therapy Experimental Treatment 1 Intervention

Group II: Cognitive rehabilitation Active Control 1 Intervention

Group III: Waitlist - Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28335664/

Cognitive Behavioral Intervention Compared to Telephone ... This study is a randomized, controlled trial that examines the effectiveness of a newly developed cognitive behavioral therapy (CBT) intervention (CBTi) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722923001001

Cognitive-Behavioral Therapy for Persistent Post- ... Cognitive-behavioral therapy (CBT) has demonstrated promise as a treatment for PPCS but requires tailoring to specifically address concussion-related targets.

3. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2024.2435283

Full article: What psychological interventions are effective ... Cognitive behavioural therapy. CBT was identified as being the most researched psychological intervention for PrPCS following a mTBI. Five of the six studies ...

4. medicaljournals.se medicaljournals.se/jrm/content/html/10.2340/16501977-2791

Effectiveness of specialized rehabilitation after mild ... Meta-analyses of the effects of cognitive behavioural therapy (CBT) or problem-solving therapy (PST) compared with usual care. All outcomes were ...

5. research.aota.org research.aota.org/ajot/article/76/Supplement%202/7613393160/23919/Cognitive-Behavioral-Therapy-Interventions-for

Cognitive Behavioral Therapy Interventions for Adults With ... Across studies, individual CBT-based interventions resulted in significantly improved psychological well-being and quality of life for both mild ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23640544/

Cognitive-behavioral prevention of postconcussion ... Conclusion: Our preliminary data suggest that CBT delivered soon after mild traumatic brain injury is well tolerated and may facilitate recovery in patients who ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2795251

Outcomes in Patients With Mild Traumatic Brain Injury ... In one study, patients with TBI who were seen within 1 week of injury and instructed on coping strategies showed improvements in sleep, anxiety, ...

8. cdc.gov cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

Traumatic Brain Injury In the United States A TBI can adversely affect a person's quality of life in numerous ways, including cognitive, behavioral/emotional, and physical effects that affect ...