Improving Psychological Wellness After Acquired Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866632
Recruitment Status : Unknown
Verified September 2010 by Toronto Rehabilitation Institute.
Recruitment status was:  Recruiting
First Posted : March 20, 2009
Last Update Posted : September 10, 2010
Ontario Neurotrauma Foundation
Peel Halton Acquired Brain Injury Services
Information provided by:
Toronto Rehabilitation Institute

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Brain Injury Behavioral: Cognitive Behavioural Therapy Not Applicable

Detailed Description:
Each year, approximately 50,000 Canadians sustain an acquired brain injury (ABI) with 16,000 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 (i.e., 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 (e.g., 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : June 2008
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Group Cognitive Behavioural Therapy Behavioral: Cognitive Behavioural Therapy
Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.

Experimental: Telephone Cognitive Behavioural Therapy Behavioral: Cognitive Behavioural Therapy
Cognitive behavioural therapy to be delivered in one-on-one via the telephone across 11 sessions, for 1 to 1.5 hours/session.

No Intervention: Group Education
No Intervention: Telephone Education

Primary Outcome Measures :
  1. Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R. [ Time Frame: 1 month and 6 months post treatment ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 month and 6 months post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • One standard deviation above the mean on the SCL-90-R, Global Severity Index (GSI)
  • 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
  • on a stable dosage and being monitored by a physician(if on psychoactive medications)
  • able to provide informed consent

Exclusion Criteria:

  • Endorsement of significant suicidal ideation at the time of evaluation
  • Engaged in another CBT or other psychotherapeutic intervention
  • Communication disorder that would preclude participation in the intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866632

Contact: Jasmin Corbie, BA 416-597-3422 ext 6207

Canada, Ontario
Peel Halton Acquired Brain Injury Service Recruiting
Mississauga, Ontario, Canada, L4Z 3G1
Contact: Le-Anh Ngo, MSc.    905-949-4411 ext 225   
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Peel Halton Acquired Brain Injury Services
Principal Investigator: Robin E Green, Ph.D., C.Psych Toronto Rehabilitation Institute
Study Chair: Cheryl Bradbury, Psy. D., C. Psych Toronto Rehabilitation Institute

Responsible Party: Dr. Robin Green, Research Scientist and Clinical Neuropsychologist, Toronto Rehabilitation Institute Identifier: NCT00866632     History of Changes
Other Study ID Numbers: 2007-ABI-COP-538
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by Toronto Rehabilitation Institute:
Brain Injury
Cognitive Therapy
Coping Skills

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System