Trial Outcomes & Findings for Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury (NCT NCT00745940)
NCT ID: NCT00745940
Last Updated: 2014-03-28
Results Overview
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.
COMPLETED
NA
105 participants
Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
2014-03-28
Participant Flow
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.
Participant milestones
| Measure |
MBCT Intervention Group
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.
|
MBCT Control Group
Control group waited.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
48
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
19
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.10 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
45.81 years
STANDARD_DEVIATION 14.80 • n=7 Participants
|
46.46 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.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.
Outcome measures
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
|---|---|---|
|
Beck Depression Inventory - II
Baseline Score on BDI-II (total score)
|
25.47 units on a scale
Standard Deviation 8.12
|
27.13 units on a scale
Standard Deviation 10.61
|
|
Beck Depression Inventory - II
Post Intervention Score on the BDI-II (total score
|
18.84 units on a scale
Standard Deviation 10.26
|
25.00 units on a scale
Standard Deviation 13.12
|
SECONDARY outcome
Timeframe: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.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.
Outcome measures
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline Score on PHQ-9 (total score)
|
11.53 units on a scale
Standard Deviation 5.03
|
14.08 units on a scale
Standard Deviation 6.52
|
|
Patient Health Questionnaire (PHQ-9)
Post Intervention Score on PHQ-9 (total score)
|
10.19 units on a scale
Standard Deviation 5.88
|
12.84 units on a scale
Standard Deviation 6.74
|
SECONDARY outcome
Timeframe: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.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.
Outcome measures
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
|---|---|---|
|
Symptom Checklist-90 Revised (Depression Subscale)
Baseline Symptom Checklist-90-R (Depression)
|
1.62 units on a scale
Standard Deviation 0.80
|
1.36 units on a scale
Standard Deviation 0.90
|
|
Symptom Checklist-90 Revised (Depression Subscale)
Post Intervention Symptom Checkl-90-R (Depression)
|
1.74 units on a scale
Standard Deviation 0.94
|
1.49 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.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.
Outcome measures
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
|---|---|---|
|
Philadelphia Mindfulness Scale (Awareness Subscale)
Baseline Score on PHLMS (Awareness Subscale)
|
33.84 units on a scale
Standard Deviation 6.62
|
33.97 units on a scale
Standard Deviation 6.02
|
|
Philadelphia Mindfulness Scale (Awareness Subscale)
Post Intervention Score on PHLMS (Awareness)
|
35.10 units on a scale
Standard Deviation 6.01
|
34.42 units on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.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.
Outcome measures
| Measure |
MBCT Intervention Group
n=38 Participants
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.
|
MBCT Control Group
n=38 Participants
Control group waited.
|
|---|---|---|
|
Philadelphia Mindfulness Scale (Acceptance Subscale)
Baseline Score on PHLMS (Acceptance Subscale)
|
28.35 units on a scale
Standard Deviation 7.42
|
28.14 units on a scale
Standard Deviation 7.45
|
|
Philadelphia Mindfulness Scale (Acceptance Subscale)
Post Intervention Score on PHLMS (Acceptance)
|
31.16 units on a scale
Standard Deviation 7.35
|
29.39 units on a scale
Standard Deviation 7.55
|
Adverse Events
MBCT Intervention Group
MBCT Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place