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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 1 month and 6 months post-treatment
Awards & highlights

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 below
Select...
I have a brain injury with a GCS of 12 or less, or significant cognitive impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month and 6 months post treatment for reporting.

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
~3970

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

Cognitive Behavioural Therapy Clinical Trial Eligibility Overview. Trial Name: NCT00866632 — N/A
Depression Research Study Groups: Group Education, Telephone Education, Group Cognitive Behavioural Therapy, Telephone Cognitive Behavioural Therapy
Depression Clinical Trial 2023: Cognitive Behavioural Therapy Highlights & Side Effects. Trial Name: NCT00866632 — N/A
Cognitive Behavioural Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00866632 — N/A
~4 spots leftby Jul 2025
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