Improving Psychological Wellness After Acquired Brain Injury

Depression Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00866632
• Other study ID #: 2007-ABI-COP-538
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2009
• Last updated: September 9, 2010
• Start date: June 2008

Study information

• Verified date: September 2010
• Source: Toronto Rehabilitation Institute
• Contact: Jasmin Corbie, BA
• Phone: 416-597-3422
• Email: Corbie.Jasmin[@]Torontorehab.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Brain Injuries
• Brain Injury
• Depression

Intervention

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

Locations

Country	Name	City	State
Canada	Peel Halton Acquired Brain Injury Service	Mississauga	Ontario
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Ontario Neurotrauma Foundation, Peel Halton Acquired Brain Injury Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Greater reduction in distress as determined by improved scores on the Global Severity Index of the Symptom Checklist 90-R.		1 month and 6 months post treatment	No
Secondary	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.		1 month and 6 months post-treatment	No