Graded Exposure Therapy for Concussion

(GET-FAB Trial)

Recruiting at 6 trial locations

Overseen By Tasha Klotz, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Cardiac disease, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

220 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a therapy called Graded Exposure Therapy for adults who have ongoing symptoms after a concussion. The therapy helps them gradually face activities they fear, which can improve their recovery. The study aims to see if this approach is more effective.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have changed your cardiac medication in the last month, you cannot participate.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have changed your cardiac medication in the last month, you may not be eligible to participate.

What data supports the idea that Graded Exposure Therapy for Concussion is an effective treatment?

The available research shows that fear avoidance behavior after a concussion is linked to negative outcomes like more symptoms and emotional distress. While the studies focus on measuring fear avoidance, they highlight the importance of addressing these behaviors to improve recovery. Although specific data on Graded Exposure Therapy for Concussion isn't provided, the research suggests that treatments targeting fear avoidance, like Graded Exposure Therapy, could potentially help by reducing these negative behaviors and improving recovery. However, the studies also indicate that current tools to measure fear avoidance need improvement, so more research is needed to confirm the effectiveness of Graded Exposure Therapy for Concussion. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB)?

Research shows that fear avoidance behavior after a concussion is linked to negative outcomes like higher symptom burden and emotional distress. Addressing these behaviors through targeted treatments, like GET FAB, may help improve recovery by reducing fear and avoidance, although direct evidence for GET FAB's effectiveness is not provided in the studies. ^{1 2 3 4 5}

What safety data exists for Graded Exposure Therapy for Concussion?

The provided research does not directly address the safety data for Graded Exposure Therapy for Concussion or its variants like GET, GET FAB. The studies focus on fear avoidance behavior, anxiety, and other factors related to concussion recovery, but do not evaluate the safety of Graded Exposure Therapy specifically. ^{1 3 6 7 8}

Is Graded Exposure Therapy a promising treatment for concussion?

Yes, Graded Exposure Therapy is a promising treatment for concussion because it helps reduce fear and avoidance behaviors, which are linked to negative outcomes like emotional distress and disability. By addressing these behaviors, the therapy can improve recovery and quality of life for those with a concussion. ^{1 3 5 6 8}

How is Graded Exposure Therapy different from other treatments for concussion?

Graded Exposure Therapy (GET) is unique because it specifically targets fear avoidance behavior, which is when people avoid activities due to fear of worsening symptoms after a concussion. This approach helps patients gradually face and overcome these fears, potentially reducing emotional distress and improving recovery, unlike other treatments that may not address this specific behavior. ^{1 3 5 6 8}

Research Team

Noah Silverberg, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for individuals who had a concussion between 1 and 12 months ago, can access the internet via computer or mobile device, have at least three moderate to severe symptoms on a specific questionnaire, and are fluent in English. It's not for those on beta-blockers, with exercise contraindications like heart disease or recent injuries, or involved in injury lawsuits.

Inclusion Criteria

I am fluent in English.

I am between 18 and 70 years old.

Access to a computer, tablet, or smartphone with internet capability

Exclusion Criteria

Currently pregnant or will become pregnant within the next 3 months

Medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)

Involved in personal injury litigation for index concussion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive graded exposure therapy, enhanced usual care, or prescribed aerobic exercise

3 months

Follow-up

Participants are monitored for changes in fear avoidance behaviour, post-concussion symptoms, and other health measures

3 months

Treatment Details

Interventions

• Graded Exposure Therapy

Trial Overview The study tests graded exposure therapy aimed at reducing fear avoidance behavior after a concussion against prescribed aerobic exercise and enhanced usual care. The goal is to see if this approach helps patients better cope with their symptoms and improve recovery.

Participant Groups

Group I: Arm 1: Graded Exposure Therapy Experimental Treatment 1 Intervention

Group II: Arm 3: Enhanced usual care Active Control 1 Intervention

Group III: Arm 2: Prescribed Aerobic Exercise Active Control 1 Intervention

Graded Exposure Therapy is already approved in Canada for the following indications:

Approved in Canada as Graded Exposure Therapy for:

• Persistent symptoms after mild traumatic brain injury (mTBI)
• Fear avoidance behavior after concussion

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

In a study of 563 adults with mild traumatic brain injury (mTBI), it was found that females exhibited higher levels of fear avoidance behavior compared to males, suggesting that clinical normative data for the Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI) should be stratified by sex.

The study also revealed that factors such as loss of consciousness and higher postconcussion symptom burden were linked to increased fear avoidance behavior, while the time since injury did not significantly affect FAB-TBI scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normative Data for the Fear Avoidance Behavior After Traumatic Brain Injury Questionnaire in a Clinical Sample of Adults With Mild TBI. Cairncross, M., Debert, CT., Hunt, C., et al.[2023]

A randomized controlled trial involving 73 adults with persistent postconcussion symptoms showed that graded exposure therapy (GET) significantly reduced fear avoidance behavior compared to operant condition-based pacing strategies plus mindfulness training (Pacing+).

The study demonstrated strong feasibility for future trials, with high treatment adherence (89% completion rate) and excellent treatment fidelity (96.8% of essential elements covered), indicating that GET could be an effective intervention to help prevent disability after concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Silverberg, ND., Cairncross, M., Brasher, PMA., et al.[2022]

The Pediatric Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (PFAB-TBI) was developed and showed strong internal consistency and moderate correlation between self-reports from children and informant reports from caregivers, indicating it is a reliable tool for assessing fear avoidance behavior after concussion.

The PFAB-TBI scores were significantly correlated with post-concussion symptoms and emotional distress, while negatively impacting quality of life, suggesting that fear avoidance behavior is an important factor to consider in the recovery process for youth after a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear avoidance behavior in youth with poor recovery from concussion: measurement properties and correlates of a new scale. Cairncross, M., Brooks, BL., Virani, S., et al.[2021]

A systematic review identified that existing patient-reported outcome measures (PROMs) for assessing fear avoidance behavior in concussion patients have insufficient content validity, indicating they may not accurately capture the intended behaviors.

Among the PROMs evaluated, the Fear Avoidance Short Form Scale showed the best measurement properties, with moderate-certainty evidence for structural validity and internal consistency, but caution is still advised in their use due to potential biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Fear Avoidance Behaviors in People With Concussion: A COSMIN-Informed Systematic Review. Sherwood, LJ., Korakakis, V., Mosler, AB., et al.[2023]

A study involving 17 college-aged individuals with recent concussions and anxiety revealed that concussions significantly disrupt daily activities, relationships, and academic/work performance, highlighting the need for comprehensive assessments beyond standard clinical evaluations.

Participants also reported changes in their self-perception and emotional state, but some found positive aspects post-injury, indicating that addressing both the negative impacts and potential benefits could enhance recovery strategies for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Recent Concussion on College-Aged Individuals with Co-Occurring Anxiety: A Qualitative Investigation. Greenberg, J., Kanaya, MR., Bannon, SM., et al.[2023]

In a study of 637 children and adolescents with concussions, those with pre-existing anxiety disorders reported significantly more concussion symptoms and higher vision symptom severity scores compared to those without anxiety, indicating a link between anxiety and increased symptom severity.

Children and adolescents with anxiety experienced prolonged recovery times, taking longer to recover from concussion symptoms, return to school, and resume physical activities, with adjusted hazard ratios indicating a threefold increase in recovery time compared to their peers without anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion symptomology and recovery in children and adolescents with pre-existing anxiety. Martin, AK., Petersen, AJ., Sesma, HW., et al.[2021]

In a study of 129 youth aged 10-18 who suffered concussions, pre-injury panic symptoms and total symptom severity were identified as strong predictors of post-injury anxiety, indicating the need for careful emotional assessment before and after a concussion.

The study found that non-sports-related concussions and vestibular dysfunction significantly increased the risk of developing clinical levels of anxiety post-injury, emphasizing the importance of comprehensive evaluations in concussion management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictors of post-injury anxiety in adolescent patients following concussion. Gillie, BL., Fazio-Sumrok, V., Eagle, SR., 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]

References

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

Normative Data for the Fear Avoidance Behavior After Traumatic Brain Injury Questionnaire in a Clinical Sample of Adults With Mild TBI. [2023]

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

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Fear avoidance behavior in youth with poor recovery from concussion: measurement properties and correlates of a new scale. [2021]

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

Quantifying Fear Avoidance Behaviors in People With Concussion: A COSMIN-Informed Systematic Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of a Recent Concussion on College-Aged Individuals with Co-Occurring Anxiety: A Qualitative Investigation. [2023]

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

Concussion symptomology and recovery in children and adolescents with pre-existing anxiety. [2021]

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

Clinical predictors of post-injury anxiety in adolescent patients following concussion. [2022]

8. 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]