N/A
N=105
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
Depression · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00745940 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Beck Depression Inventory - II — 25.47; 27.13; 18.84; 25.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MBCT for TBI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lakehead University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory - II |
25.47; 27.13; 18.84; 25.00 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
11.53; 14.08; 10.19; 12.84 | — |
| SECONDARY Symptom Checklist-90 Revised (Depression Subscale) |
1.62; 1.36; 1.74; 1.49 | — |
| SECONDARY Philadelphia Mindfulness Scale (Awareness Subscale) |
33.84; 33.97; 35.10; 34.42 | — |
| SECONDARY Philadelphia Mindfulness Scale (Acceptance Subscale) |
28.35; 28.14; 31.16; 29.39 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00745940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.