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Improving Psychological Wellness After Acquired Brain Injury

NCT ID: NCT00866632

Last Updated: 2010-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group Cognitive Behavioural Therapy

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.

Telephone Cognitive Behavioural Therapy

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

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

Group Education

Group Type NO_INTERVENTION

No interventions assigned to this group

Telephone Education

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioural Therapy

Cognitive behavioural therapy to be delivered in a group setting for 11 sessions, for 1 to 1.5 hours/session.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Neurotrauma Foundation

OTHER

Sponsor Role collaborator

Peel Halton Acquired Brain Injury Services

UNKNOWN

Sponsor Role collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role lead

Responsible Party

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Toronto Rehabilitation Institute

Principal Investigators

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Robin E Green, Ph.D., C.Psych

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Cheryl Bradbury, Psy. D., C. Psych

Role: STUDY_CHAIR

Toronto Rehabilitation Institute

Locations

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Peel Halton Acquired Brain Injury Service

Mississauga, Ontario, Canada

Site Status RECRUITING

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jasmin Corbie, BA

Role: CONTACT

[email protected]
416-597-3422 ext. 6207

Facility Contacts

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Le-Anh Ngo, MSc.

Role: primary

[email protected]
905-949-4411 ext. 225

Other Identifiers

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2007-ABI-COP-538

Identifier Type: -

Identifier Source: org_study_id