NCT00866632

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

2.5 years

First QC Date

March 19, 2009

Last Update Submit

September 9, 2010

Conditions

DepressionAnxietyBrain Injury

Keywords

DepressionAnxietyBrain InjuryCognitive TherapyCoping Skills

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (4)

Group Cognitive Behavioural Therapy

EXPERIMENTAL
Behavioral: Cognitive Behavioural Therapy

Telephone Cognitive Behavioural Therapy

EXPERIMENTAL
Behavioral: Cognitive Behavioural Therapy

Group Education

NO INTERVENTION

Telephone Education

NO INTERVENTION

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

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

Group Cognitive Behavioural Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peel Halton Acquired Brain Injury Service

Mississauga, Ontario, L4Z 3G1, Canada

RECRUITING

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersBrain Injuries

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robin E Green, Ph.D., C.Psych

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

  • Cheryl Bradbury, Psy. D., C. Psych

    Toronto Rehabilitation Institute

    STUDY CHAIR

Central Study Contacts

Jasmin Corbie, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Last Updated

September 10, 2010

Record last verified: 2010-09

Locations

CA(2)