Your session is about to expire
← Back to Search
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 1 month and 6 months post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ 1 month and 6 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 6 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R.
Secondary outcome measures
Reduction in psychological distress and improvement in coping as determined by improved scores on the Depression Anxiety Stress Scale, Community Integration Scale, and the Satisfaction with Life questionnaire.
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
2016
Completed Phase 3
~3800
Find a Location
Who is running the clinical trial?
Ontario Neurotrauma FoundationOTHER
22 Previous Clinical Trials
1,028 Total Patients Enrolled
3 Trials studying Depression
146 Patients Enrolled for Depression
Peel Halton Acquired Brain Injury ServicesUNKNOWN
Toronto Rehabilitation InstituteLead Sponsor
50 Previous Clinical Trials
5,546 Total Patients Enrolled
1 Trials studying Depression
92 Patients Enrolled for Depression
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who should be considered as optimal subjects for this investigation?
"To join this research, individuals must have a diagnosis of depression and fall in the age bracket between 18 to 65 years. Approximately 75 participants are required for the study."
Answered by AI
Does this clinical trial admit participants less than 25 years old?
"This clinical trial necessitates that participants be within the 18 to 65 year old age range. By contrast, there are 371 and 1672 trials respectively for minors and seniors."
Answered by AI
Is there availability in the trial for participants?
"Unfortunately, this clinical trial is not presently open to recruitment. It had been initialy posted on June 1st 2008 and was most recently amended on September 9th 2010. Despite this, there are currently 2211 other medical studies that are actively recruiting patients."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger