Recruiting

Psychological Wellness

Sponsor:

Toronto Rehabilitation Institute

Code:

NCT00866632

Conditions

Depression

Anxiety

Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy

Cognitive Behavioural Therapy

Study Details

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.

Conditions

Depression

Anxiety

Brain Injury

Study ID

NCT00866632

Start date

Jun, 2008

Status verified date

Sep, 2010

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group Cognitive Behavioural Therapy

experimental: Telephone Cognitive Behavioural Therapy

no intervention: Group Education

no intervention: Telephone Education

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jasmin Corbie, BA

416-597-3422Corbie.Jasmin@Torontorehab.on.ca

Locations

Peel Halton Acquired Brain Injury Service

Recruiting

Mississauga, Ontario, Canada, L4Z 3G1

Contacts

Le-Anh Ngo, MSc.

905-949-4411leanh@phabis.com

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G 2A2

More Information

Sponsor

Toronto Rehabilitation Institute

Last update posted

Sep 10, 2010

Last verified

Sep, 2010

Keywords

  • Depression
  • Anxiety
  • Brain Injury
  • Cognitive Therapy
  • Coping Skills

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Rehabilitation Institute on 2010-09-10.