Clinical trial NCT00745940: Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
Official title: A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Traumatic Brain Injury
Keywords: Mindfulness-Based Cognitive Therapy
MBCT
Depression
Traumatic Brain Injury
TBI
Lead sponsor: Lakehead University
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2008-09-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* traumatic brain injury suffered more than one year ago but less than five
* Evidence of depression post-traumatic brain injury (Beck Depression Inventory-II score of 16 or greater)
* Ability to speak and read English
* Age 18 or more

Exclusion Criteria:

* Inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (California Verbal Learning Test, Digit Span subsection of Wechsler Adult Intelligence Scale); verbal fluency and executive functioning (Controlled Oral Word Association Test); verbal abstract reasoning (Similarities subsection of Wechsler Adult Intelligence Scale); and executive functioning (Trail Making Test).
* Evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (Beck Depression Inventory-II and Symptom Checklist-90-R will supplement the decision-making process of study clinicians).

Primary outcomes:
measure: Beck Depression Inventory - II
timeFrame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
measure: Symptom Checklist-90 Revised (Depression Subscale)
timeFrame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
measure: Philadelphia Mindfulness Scale (Awareness Subscale)
timeFrame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
measure: Philadelphia Mindfulness Scale (Acceptance Subscale)
timeFrame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Rehabilitation Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: St. Joseph's Care Group
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Lakehead University
name: Michel Bédard, PhD
role: PRINCIPAL_INVESTIGATOR
References: