Back to resultsMindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
Primary Purpose
Depression, Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MBCT for TBI
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Mindfulness-Based Cognitive Therapy, MBCT, Depression, Traumatic Brain Injury, 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).
Sites / Locations
- Ottawa Hospital Rehabilitation Centre
- St. Joseph's Care Group
- Toronto Rehabilitation Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MBCT Intervention Group
MBCT Control Group
Arm Description
The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
Control group waited.
Outcomes
Primary Outcome Measures
Beck Depression Inventory - II
The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.
Secondary Outcome Measures
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from "0" (not at all) to "3" (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27.
Symptom Checklist-90 Revised (Depression Subscale)
The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from "Not at All" to "Extremely" with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.
Philadelphia Mindfulness Scale (Awareness Subscale)
The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Philadelphia Mindfulness Scale (Acceptance Subscale)
The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Full Information
NCT ID
NCT00745940
First Posted
September 2, 2008
Last Updated
February 27, 2014
Sponsor
Lakehead University
Collaborators
Ontario Neurotrauma Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00745940
Brief Title
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lakehead University
Collaborators
Ontario Neurotrauma Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Traumatic Brain Injury
Keywords
Mindfulness-Based Cognitive Therapy, MBCT, Depression, Traumatic Brain Injury, TBI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCT Intervention Group
Arm Type
Experimental
Arm Description
The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
Arm Title
MBCT Control Group
Arm Type
No Intervention
Arm Description
Control group waited.
Intervention Type
Behavioral
Intervention Name(s)
MBCT for TBI
Other Intervention Name(s)
MBCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory - II
Description
The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.
Time Frame
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from "0" (not at all) to "3" (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27.
Time Frame
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Title
Symptom Checklist-90 Revised (Depression Subscale)
Description
The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from "Not at All" to "Extremely" with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.
Time Frame
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Title
Philadelphia Mindfulness Scale (Awareness Subscale)
Description
The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Time Frame
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Title
Philadelphia Mindfulness Scale (Acceptance Subscale)
Description
The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Time Frame
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bédard, PhD
Organizational Affiliation
Lakehead University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital Rehabilitation Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8M2
Country
Canada
Facility Name
St. Joseph's Care Group
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 5G7
Country
Canada
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
We'll reach out to this number within 24 hrs