Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365776
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2022-03-10
Brief Title:
Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Graded Exposure Therapy for Fear Avoidance Behaviour GET FAB After Concussion
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GET-FAB
Brief Summary:
Concussions are very common Although many people recover well from concussion some will have persistent symptoms and difficulties with daily activities How people cope with their symptoms following concussion powerfully influences their recovery Fear avoidance behaviour is a particularly unhelpful approach to coping in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation The investigators developed and pilot tested a behavioural therapy called graded exposure therapy to reduce fear avoidance behaviour Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery The GET FAB after concussion study will assess the effectiveness of graded exposure therapy
Detailed Description:
GET FAB is a multisite randomized controlled trial designed to evaluate a behavioural treatment graded exposure therapy for adults with persistent symptoms after concussion Participants in this study will be recruited from a network of concussion clinics in Canada This study follows from the investigators prior work establishing that 1 fear avoidance behaviour is a risk factor for poor concussion outcome 2 graded exposure therapy reduces fear avoidance behaviour and 3 graded exposure therapy is perceived as credible and is well-tolerated by patients with persistent post-concussion symptoms
Participants will be assigned at random in a 122 ratio to receive enhanced usual care graded exposure therapy group or another therapy that might have similar benefits prescribed aerobic exercise The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour
Participants will be assigned at random in a 122 ratio to receive enhanced usual care graded exposure therapy group or another therapy that might have similar benefits prescribed aerobic exercise The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None