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

NCT00745940 | Completed Results

• 1 other identifier: ABI-MIND2-476
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Depression; Traumatic Brain Injury

Keywords

Mindfulness-Based Cognitive Therapy; MBCT; Depression; Traumatic Brain Injury; TBI

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

• Symptom Checklist-90 Revised (Depression Subscale)

  Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

• Philadelphia Mindfulness Scale (Awareness Subscale)

  Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

• Philadelphia Mindfulness Scale (Acceptance Subscale)

  Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Study Arms (2)

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.

Behavioral: MBCT for TBI

MBCT Control Group

NO INTERVENTION

Control group waited.

Interventions

MBCT for TBI BEHAVIORAL

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.

Also known as: MBCT

MBCT Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lakehead University: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (3)

Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, K1H 8M2, Canada

Location

St. Joseph's Care Group

Thunder Bay, Ontario, P7B 5G7, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Depression; Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Michel Bédard
• Organization: Lakehead University

mbedard@lakeheadu.ca

807-343-8630

Study Officials

• Michel Bédard, PhD

  Lakehead University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: November 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 28, 2014
• Results First Posted: February 17, 2014

Record last verified: 2014-02

Locations

CA (3)