Improving Psychological Wellness After Acquired Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Toronto Rehabilitation Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ontario Neurotrauma Foundation
Peel Halton Acquired Brain Injury Services
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00866632
First received: March 19, 2009
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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 Intervention
Depression
Anxiety
Brain Injury
Behavioral: Cognitive Behavioural Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 month and 6 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: June 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866632

Contacts
Contact: Jasmin Corbie, BA 416-597-3422 ext 6207 Corbie.Jasmin@Torontorehab.on.ca

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

No publications provided

Responsible Party: Dr. Robin Green, Research Scientist and Clinical Neuropsychologist, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00866632     History of Changes
Other Study ID Numbers: 2007-ABI-COP-538
Study First Received: March 19, 2009
Last Updated: September 9, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Brain Injuries
Depression
Depressive Disorder
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Mood Disorders
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014