Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866632
Status:
UNKNOWN
Last Update Posted:
2010-09-10
First Post:
2009-03-19
Brief Title:
Improving Psychological Wellness After Acquired Brain Injury
Sponsor:
Toronto Rehabilitation Institute
Organization:
Toronto Rehabilitation Institute
Study Overview
Official Title:
Improving Mood Adjustment and Coping in People With Acquired Brain Injury A Randomized Controlled Trial to Examine the Efficacy of a Cognitive Behaviour Therapy Protocol Adapted for Brain Injury and Remote Administration of Services
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of the study is to investigate the potential benefits of a psychological therapy called cognitive behaviour therapy CBT for improving emotional well being after acquired brain injury and to demonstrate its efficacy in both under telephone T-CBT and face-to-face group G-CBT modes of delivery compared to an educational control group
Detailed Description:
Each year approximately 50000 Canadians sustain an acquired brain injury ABI with 16000 of those individuals living in Ontario Individuals with ABI not only suffer significant cognitive and motor impairments but they often experience debilitating emotional distress Emotional distress uniquely contributes to poorer functional outcomes and decreased quality of life Moreover emotional distress confers risk for the subsequent development of serious mental illness such as depression anxiety disorders suicide and possibly psychotic illness While a great deal of clinical resources are devoted to the cognitive and motor sequelae of ABI the concomitant psychological and psychiatric sequelae of brain injury often receive relatively little attention in in-patient and day-hospital programs and the expense and inaccessibility of therapeutic services are often prohibitive for consumers in the sub-acute and chronic stages of brain injury Moreover few psychological interventions are tailored to the specific cognitive needs and content issues of brain-injured consumers We have taken a well-validated mode of psychological treatment used in face-to-face therapeutic settings - Cognitive Behaviour Therapy CBT - and adapted it for the needs of brain-injured clients Thus far the protocol has been adapted for content issues and cognitive impairments of people with ABI it has been adapted for telehealth delivery it has been through expert review and its feasibility has been assessed The aim of the proposed research is to demonstrate in a randomized control trial RCT the efficacy of the adapted protocol both in a standard delivery modality ie face to face and group and in the telehealth delivery modality in comparison to an education control group The treatment is focused on improving coping skills and decreasing psychological distress post-ABI If proven effective the intervention could be used cost-effectively by a range of therapists eg Psychologists Psychiatrists Occupational Therapists and Social Workers to improve coping adjustment and quality of life for ABI consumers irrespective of geographical location mobility restrictions or economic status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None