DepressionNCT00745940
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
A study testing MBCT for TBI in people with Depression and Traumatic Brain Injury, run by Lakehead University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Traumatic Brain Injury
- What is being tested?
- MBCT for TBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2009to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
St. Joseph's Care Group
Thunder Bay, Ontario, P7B 5G7
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
About this study
Official title: A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
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.
Read the 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.
- Conditions
- Depression, Traumatic Brain Injury
- Being tested
- MBCT for TBI
- Keywords
- Mindfulness-Based Cognitive Therapy, MBCT, Depression, Traumatic Brain Injury, TBI
- Medical subject headings
- Depression, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT for TBIBehavioural
Also called MBCT
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 group | Role | What they receive |
|---|---|---|
| MBCT Intervention Group | Experimental | 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. Receives: Behavioral: MBCT for TBI |
| MBCT Control Group | No intervention | Control group waited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Secondary outcomes (4)
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.
Measured: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
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.
Measured: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
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.
Measured: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
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.
Measured: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Sponsor
- Investigators
- Michel Bédard, PhD, Principal investigator, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745940
- Sponsor's protocol ID
- ABI-MIND2-476
- Status last verified
- Feb 2014
- First submitted
- 2 Sep 2008
- Last updated
- 28 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
- ClinicalTrials.gov ID
- NCT00745940
- Acronym / sponsor ID
- ABI-MIND2-476
- Conditions
- Depression, Traumatic Brain Injury
- Keywords
- Mindfulness-Based Cognitive Therapy, MBCT, Depression, Traumatic Brain Injury, TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 17 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT Intervention Group | Experimental | Behavioral: MBCT for TBIThe 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 | No intervention | –Control group waited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT for TBIAlso: MBCTSubjects 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. | Behavioural | MBCT Intervention Group |
Primary outcome
Beck Depression Inventory - II
Time frame: 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.
4 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Symptom Checklist-90 Revised (Depression Subscale)
Time frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Philadelphia Mindfulness Scale (Awareness Subscale)
Time frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Philadelphia Mindfulness Scale (Acceptance Subscale)
Time frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Bédard, PhD principal investigator
Lakehead University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT for TBI in people with Depression and Traumatic Brain Injury, run by Lakehead University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory - II (time frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.