Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury - Full Text View

Sponsors and Collaborators:	Lakehead University Ontario Neurotrauma Foundation
Information provided by:	Lakehead University
ClinicalTrials.gov Identifier:	NCT00745940

Purpose

The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury.

The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.

Condition	Intervention
Depression Traumatic Brain Injury	Behavioral: Mindfulness-Based Cognitive Therapy

MedlinePlus related topics: Depression Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	A Multi-Site, Randomized, Controlled Trial of a Mindfulness-Based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.

Further study details as provided by Lakehead University:

Primary Outcome Measures:

Evidence of decreased depression symptoms as indicated by scores from a variety of scales (BDI-II, PHQ-9, HADS and SCL-90-R). [ Time Frame: End of treatment, 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evidence of improvements in pain intensity (VAS), general/mental health (SF-36), functioning (MPAI-4, MIRECC-GAF), attention/concentration (Digit Section of WAIS), satisfaction with life (SWLS), and other psychological symptoms (SCLR-90-R). [ Time Frame: End of treatment, 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. MBCT Intervention: Experimental	Behavioral: Mindfulness-Based Cognitive Therapy Subjects will participate in a 10-week Mindfulness-Based Cognitive Therapy Program led by two trained facilitators. Weekly one-and-a-half hour group sessions will guide subjects through exercises such as meditation, awareness, and breathing techniques aimed at developing skills to help with tension, stress, anxiety and depression. Subjects will be encouraged to practice skills at home and in daily life.
2. Control: No Intervention

Arms

Assigned Interventions

1. MBCT Intervention: Experimental

Behavioral: Mindfulness-Based Cognitive Therapy

Subjects will participate in a 10-week Mindfulness-Based Cognitive Therapy Program led by two trained facilitators. Weekly one-and-a-half hour group sessions will guide subjects through exercises such as meditation, awareness, and breathing techniques aimed at developing skills to help with tension, stress, anxiety and depression. Subjects will be encouraged to practice skills at home and in daily life.

2. Control: No Intervention

Detailed Description:

Major depression is a significant chronic problem for people with traumatic brain injury (TBI), and its treatment is difficult. A promising approach to treat depression is mindfulness-based cognitive therapy (MBCT), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (MBSR) and cognitive behavioural therapy (CBT). This multi-site, randomized, controlled trial of a MBCT intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with TBI. MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of TBI.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

TBI suffered more than one year ago but less than five
Evidence of depression post-TBI (BDI-II score of 16 or greater)
Ability to speak and read English
Age 18 or more

Exclusion Criteria:

Evidence of post-traumatic amnesia (GOAT)
Inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (CVLT, Digit Span subsection of WAIS); verbal fluency and executive functioning (COWAT); verbal abstract reasoning (Similarities subsection of WAIS); and executive functioning (Trail Making Test, Stroop Test).
Evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (BDI-II and SCL-90-R will supplement the decision-making process of study clinicians).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745940

Contacts

Contact: Michel Bédard, PhD

807-343-8630

mbedard@lakeheadu.ca

Locations

Canada, Ontario
Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, Canada, K1H 8M2
St. Joseph's Care Group
Thunder Bay, Ontario, Canada, P7B 5G7
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2

Sponsors and Collaborators

Lakehead University

Ontario Neurotrauma Foundation

Investigators

Principal Investigator:

Michel Bédard, PhD

Lakehead University

More Information

Responsible Party:	Lakehead University ( Michel Bédard )
Study ID Numbers:	ABI-MIND2-476
Study First Received:	September 2, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745940
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lakehead University:

Mindfulness-Based Cognitive Therapy
MBCT
Depression
Traumatic Brain Injury
TBI

Study placed in the following topic categories:

Craniocerebral Trauma
Depression
Mental Disorders
Wounds and Injuries
Mood Disorders
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Depressive Disorder
Brain Injuries
Behavioral Symptoms

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009