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

A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745940

Enrollment

105

Registered

2008-09-03

Start date

2009-11-30

Completion date

2012-05-31

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Traumatic Brain Injury

Keywords

Mindfulness-Based Cognitive Therapy, MBCT, Depression, Traumatic Brain Injury, TBI

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.

Interventions

BEHAVIORALMBCT for TBI

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Beck Depression Inventory - II	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.

Secondary

Measure	Time frame	Description
Patient Health Questionnaire (PHQ-9)	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.
Symptom Checklist-90 Revised (Depression Subscale)	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.
Philadelphia Mindfulness Scale (Awareness Subscale)	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.
Philadelphia Mindfulness Scale (Acceptance Subscale)	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.

Countries

Canada

Participant flow

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.

Participants by arm

Arm	Count
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.	38
MBCT Control Group Control group waited.	38
Total	76

Baseline characteristics

Characteristic	MBCT Control Group	MBCT Intervention Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	38 Participants	38 Participants	76 Participants
Age, Continuous	45.81 years STANDARD_DEVIATION 14.8	47.10 years STANDARD_DEVIATION 12.03	46.46 years STANDARD_DEVIATION 13.06
Region of Enrollment Canada	38 participants	38 participants	76 participants
Sex: Female, Male Female	15 Participants	19 Participants	34 Participants
Sex: Female, Male Male	23 Participants	19 Participants	42 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 57	0 / 48
serious Total, serious adverse events	0 / 57	0 / 48

Outcome results

Primary

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.