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
Results First Received: June 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Depression
Traumatic Brain Injury
Intervention: Behavioral: MBCT for TBI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
n/a

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    MBCT Intervention Group     MBCT Control Group  
STARTED     57     48  
COMPLETED     38     38  
NOT COMPLETED     19     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    MBCT Intervention Group     MBCT Control Group     Total  
Number of Participants  
[units: participants]
  38     38     76  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     38     38     76  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.10  ± 12.03     45.81  ± 14.80     46.46  ± 13.06  
Gender  
[units: participants]
     
Female     19     15     34  
Male     19     23     42  
Region of Enrollment  
[units: participants]
     
Canada     38     38     76  



  Outcome Measures
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1.  Primary:   Beck Depression Inventory - II   [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ]

2.  Secondary:   Patient Health Questionnaire (PHQ-9)   [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ]

3.  Secondary:   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. ]

4.  Secondary:   Philadelphia Mindfulness Scale (Awareness Subscale)   [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ]

5.  Secondary:   Philadelphia Mindfulness Scale (Acceptance Subscale)   [ Time Frame: Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: mbedard@lakeheadu.ca


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