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

Lakehead University

Status: Completed

Conditions: Traumatic Brain Injury; Depression

Treatments: Behavioral: MBCT for TBI

Study type: Interventional

Funder types: Other

Identifiers

NCT00745940

ABI-MIND2-476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

MBCT Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: MBCT for TBI

MBCT Control Group

No Intervention group

Description:

Control group waited.