ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00745940
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : February 17, 2014
Last Update Posted : March 28, 2014
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Lakehead University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Traumatic Brain Injury
Intervention Behavioral: MBCT for TBI
Enrollment 105

Recruitment Details Participants were sought from local sources including: outpatient programs/clinics for individuals with neurological injury, newspaper and television advertisements, a brain injury association, social events related to treatment of brain injury, as well as through appeals to family physicians, psychologists, chiropractors and nurse practitioners.
Pre-assignment Details  
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Period Title: Overall Study
Started 57 48
Completed 38 38
Not Completed 19 10
Arm/Group Title MBCT Intervention Group MBCT Control Group Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 38 38 76
Hide Baseline Analysis Population Description
We initially had 57 MBCT Intervention group participants and 48 Control group participants. 29 participants (28%) did not complete the study – 17 prior to their respective arm starting and 8 during the intervention. Thus, for our analysis we had 38 in each arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
 100.0%
38
 100.0%
76
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 38 participants 76 participants
47.10  (12.03) 45.81  (14.80) 46.46  (13.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 76 participants
Female
19
  50.0%
15
  39.5%
34
  44.7%
Male
19
  50.0%
23
  60.5%
42
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 38 participants 38 participants 76 participants
38 38 76
1.Primary Outcome
Title Beck Depression Inventory - II
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Score on BDI-II (total score) 25.47  (8.12) 27.13  (10.61)
Post Intervention Score on the BDI-II (total score 18.84  (10.26) 25.00  (13.12)
2.Secondary Outcome
Title Patient Health Questionnaire (PHQ-9)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Score on PHQ-9 (total score) 11.53  (5.03) 14.08  (6.52)
Post Intervention Score on PHQ-9 (total score) 10.19  (5.88) 12.84  (6.74)
3.Secondary Outcome
Title Symptom Checklist-90 Revised (Depression Subscale)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Symptom Checklist-90-R (Depression) 1.62  (0.80) 1.36  (0.90)
Post Intervention Symptom Checkl-90-R (Depression) 1.74  (0.94) 1.49  (1.04)
4.Secondary Outcome
Title Philadelphia Mindfulness Scale (Awareness Subscale)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Score on PHLMS (Awareness Subscale) 33.84  (6.62) 33.97  (6.02)
Post Intervention Score on PHLMS (Awareness) 35.10  (6.01) 34.42  (5.17)
5.Secondary Outcome
Title Philadelphia Mindfulness Scale (Acceptance Subscale)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Score on PHLMS (Acceptance Subscale) 28.35  (7.42) 28.14  (7.45)
Post Intervention Score on PHLMS (Acceptance) 31.16  (7.35) 29.39  (7.55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MBCT Intervention Group MBCT Control Group
Hide Arm/Group 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.
All-Cause Mortality
MBCT Intervention Group MBCT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MBCT Intervention Group MBCT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MBCT Intervention Group MBCT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/48 (0.00%) 
It is not possible to generalize our findings to the general population of people with a traumatic brain injury. Participants self-selected. Some did not complete the intervention. The control group was a “wait-list” control group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michel Bédard
Organization: Lakehead University
Phone: 807-343-8630
Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT00745940     History of Changes
Other Study ID Numbers: ABI-MIND2-476
First Submitted: September 2, 2008
First Posted: September 3, 2008
Results First Submitted: June 28, 2013
Results First Posted: February 17, 2014
Last Update Posted: March 28, 2014