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Cognitive Behavioural Therapy for Traumatic Brain Injury
N/A
Waitlist Available
Led By Robin E Green, Ph.D., C.Psych
Research Sponsored by Toronto Rehabilitation Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe brain injury, operationalized as a GCS of 12 or less in TBI participants and cognitive impairment of at least two standard deviations below expected levels in at least one cognitive domain in all participants
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate whether CBT can improve emotional wellbeing for people with acquired brain injury, delivered either over the phone or in a group setting.
Who is the study for?
This trial is for individuals who have experienced a moderate to severe brain injury and are showing signs of emotional distress like depression or anxiety. They should be able to understand the study and agree to participate, not currently in another similar therapy, and must not have communication issues that would interfere with therapy.
What is being tested?
The study tests cognitive behavioural therapy (CBT) as a way to improve emotional well-being after brain injury. It compares two ways of delivering CBT—over the phone (T-CBT) and in person (G-CBT)—against an educational control group to see which is more effective.
What are the potential side effects?
CBT generally does not cause physical side effects but can sometimes lead to temporary increases in distress as participants work through difficult emotions and experiences during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a brain injury with a GCS of 12 or less, or significant cognitive impairment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Telephone Cognitive Behavioural TherapyExperimental Treatment1 Intervention
Group II: Group Cognitive Behavioural TherapyExperimental Treatment1 Intervention
Group III: Group EducationActive Control1 Intervention
Group IV: Telephone EducationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioural Therapy
2002
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
Ontario Neurotrauma FoundationOTHER
23 Previous Clinical Trials
1,052 Total Patients Enrolled
3 Trials studying Depression
146 Patients Enrolled for Depression
Peel Halton Acquired Brain Injury ServicesUNKNOWN
Toronto Rehabilitation InstituteLead Sponsor
54 Previous Clinical Trials
5,951 Total Patients Enrolled
1 Trials studying Depression
92 Patients Enrolled for Depression
Robin E Green, Ph.D., C.PsychPrincipal InvestigatorToronto Rehabilitation Institute
Cheryl Bradbury, Psy. D., C. PsychStudy ChairToronto Rehabilitation Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently participating in another therapy like CBT.I have a brain injury with a GCS of 12 or less, or significant cognitive impairment.I am on a stable dose of psychoactive medication and under doctor's care.
Research Study Groups:
This trial has the following groups:- Group 1: Group Education
- Group 2: Telephone Education
- Group 3: Group Cognitive Behavioural Therapy
- Group 4: Telephone Cognitive Behavioural Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.