Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
This study is currently recruiting participants.
Verified June 2011 by Lakehead University
Sponsor:
Lakehead University
Collaborator:
Ontario Neurotrauma Foundation
Information provided by:
Lakehead University
ClinicalTrials.gov Identifier:
NCT00745940
First received: September 2, 2008
Last updated: June 24, 2011
Last verified: June 2011
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population. |
Resource links provided by NLM:
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: | November 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. MBCT Intervention |
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.
Other Name: MBCT
|
| No Intervention: 2. Control |
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 | Recruiting |
| Ottawa, Ontario, Canada, K1H 8M2 | |
| Principal Investigator: Shawn Marshall, MD MSc FRCPC | |
| St. Joseph's Care Group | Recruiting |
| Thunder Bay, Ontario, Canada, P7B 5G7 | |
| Principal Investigator: Michel Bédard, PhD | |
| Toronto Rehabilitation Institute | Recruiting |
| Toronto, Ontario, Canada, M5G 2A2 | |
| Principal Investigator: Nora Cullen, MD MSc FRCPC | |
Sponsors and Collaborators
Lakehead University
Ontario Neurotrauma Foundation
Investigators
| Principal Investigator: | Michel Bédard, PhD | Lakehead University |
More Information
No publications provided
| Responsible Party: | Michel Bédard, Lakehead University |
| ClinicalTrials.gov Identifier: | NCT00745940 History of Changes |
| Other Study ID Numbers: | ABI-MIND2-476 |
| Study First Received: | September 2, 2008 |
| Last Updated: | June 24, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lakehead University:
|
Mindfulness-Based Cognitive Therapy MBCT Depression Traumatic Brain Injury TBI |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Brain Injuries Behavioral Symptoms Mood Disorders Mental Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013