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Sponsors and Collaborators: |
Lakehead University Ontario Neurotrauma Foundation |
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Information provided by: | Lakehead University |
ClinicalTrials.gov Identifier: | NCT00745940 |
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 |
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Depression Traumatic Brain Injury |
Behavioral: Mindfulness-Based Cognitive Therapy |
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. |
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 |
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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.
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2. Control: No Intervention |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michel Bédard, PhD | 807-343-8630 | mbedard@lakeheadu.ca |
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 |
Principal Investigator: | Michel Bédard, PhD | Lakehead University |
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 |
Mindfulness-Based Cognitive Therapy MBCT Depression Traumatic Brain Injury TBI |
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 |
Nervous System Diseases |