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Improving Psychological Wellness After Acquired Brain Injury

Primary Purpose

Depression, Anxiety, Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Cognitive Behavioural Therapy
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Anxiety, Brain Injury, Cognitive Therapy, Coping Skills

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peel Halton Acquired Brain Injury ServiceRecruiting
  • Toronto Rehabilitation InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Group Cognitive Behavioural Therapy

Telephone Cognitive Behavioural Therapy

Group Education

Telephone Education

Arm Description

Outcomes

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.

Full Information

First Posted
March 19, 2009
Last Updated
September 9, 2010
Sponsor
Toronto Rehabilitation Institute
Collaborators
Ontario Neurotrauma Foundation, Peel Halton Acquired Brain Injury Services
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1. Study Identification

Unique Protocol Identification Number
NCT00866632
Brief Title
Improving Psychological Wellness After Acquired Brain Injury
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Ontario Neurotrauma Foundation, Peel Halton Acquired Brain Injury Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Brain Injury
Keywords
Depression, Anxiety, Brain Injury, Cognitive Therapy, Coping Skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Title
Telephone Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Title
Group Education
Arm Type
No Intervention
Arm Title
Telephone Education
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Cognitive behavioural therapy to be delivered in one-on-one via the telephone across 11 sessions, for 1 to 1.5 hours/session.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmin Corbie, BA
Phone
416-597-3422
Ext
6207
Email
Corbie.Jasmin@Torontorehab.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin E Green, Ph.D., C.Psych
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Bradbury, Psy. D., C. Psych
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Peel Halton Acquired Brain Injury Service
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Z 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le-Anh Ngo, MSc.
Phone
905-949-4411
Ext
225
Email
leanh@phabis.com
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Improving Psychological Wellness After Acquired Brain Injury

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