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

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Lakehead University
ClinicalTrials.gov Identifier:
NCT00745940
First received: September 2, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Depression
Traumatic Brain Injury
Behavioral: MBCT for TBI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.

Resource links provided by NLM:


Further study details as provided by Lakehead University:

Primary Outcome Measures:
  • Beck Depression Inventory - II [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ] [ Designated as safety issue: No ]
    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.


Enrollment: 105
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: MBCT 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.
Other Name: MBCT
No Intervention: MBCT Control Group
Control group waited.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745940

Locations
Canada, Ontario
Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, Canada, K1H 8M2
St. Joseph's Care Group
Thunder Bay, Ontario, Canada, P7B 5G7
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Lakehead University
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Michel Bédard, PhD Lakehead University
  More Information

No publications provided

Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT00745940     History of Changes
Other Study ID Numbers: ABI-MIND2-476
Study First Received: September 2, 2008
Results First Received: June 28, 2013
Last Updated: February 27, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lakehead University:
Mindfulness-Based Cognitive Therapy
MBCT
Depression
Traumatic Brain Injury
TBI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014