Wellness Programs for Brain-Injured Individuals
Condition: Depression; Anxiety; Stroke
MeSH terms: Depression
Study type: Interventional

Summary: 
      Summary: Thousands of Veterans suffer a stroke every year, and these individuals often suffer
      emotional and cognitive changes that negatively affect their quality of life as well as their
      ability to recover. In addition to traditional rehabilitation such as physical and
      occupational therapy, a number of alternative treatments are now being studied for their
      ability to enhance patients' recovery following stroke. One of these treatments,
      Mindfulness-Based Stress Reduction or MBSR, involves an 8-week course that teaches
      individuals strategies such as breathing techniques, meditation, and movement therapy. The
      current pilot study proposes to teach MBSR to a group of Veterans with a history of stroke to
      determine whether this type of intervention is feasible, acceptable to patients, and shows
      preliminary evidence of beneficial effects on psychological and cognitive functioning. The
      investigators hope to find that MBSR is a useful, additional intervention that can improve
      Veterans' well-being and quality of life as they recover from stroke.
    

Detailed description: 
      Description: Stroke affects approximately 800,000 Americans every year, including thousands
      of Veterans, and is a leading cause of disability in the US. While many stroke patients
      receive rehabilitation during the acute and post-acute phases of stroke, many individuals
      suffer chronic deficits and have few options for continued treatment. A number of low-cost,
      alternative treatments are now being tested for their usefulness in treating
      neuropsychological deficits in chronic stroke patients. One of the best studied of these
      treatments is Mindfulness-Based Stress Reduction (MBSR), which involves an 8-week course led
      by a trained instructor. MBSR teaches individuals strategies for coping with their injury,
      such as meditation, breathing techniques, and sensory awareness. A handful of preliminary
      studies have shown that MBSR is effective in reducing symptoms of depression and anxiety in
      stroke patients, as well as enhancing performance on cognitive tasks. However, only a single
      randomized controlled trial of MBSR in stroke has been published to date, and that study
      suffered from a number of weaknesses such as the lack of an active control group. Moreover,
      no previous study has assessed the usefulness of MBSR for stroke in a Veteran population.
      Therefore, the current study proposes to undertake a rigorous, randomized controlled pilot
      study of MBSR in Veterans with a history of stroke, using an active control group, blinded
      examiners, and a 3-month follow-up session to determine whether any benefits of MBSR are
      long-lasting. For the study, 60 Veterans with a history of chronic stroke will be recruited:
      30 patients will be randomly assigned to the MBSR intervention, and 30 patients will be
      assigned to a Brain Health education program, which will be matched to the MBSR group with
      respect to the instructor, number of hours of instruction, homework activities, and class
      size. A blinded examiner will complete a neuropsychological assessment of patients' emotional
      and cognitive status at three time points: 1) prior to the intervention, 2) following the
      intervention (within 1 week), and 3) three months later. The investigators will evaluate a
      number of feasibility factors in this pilot study, including patient recruitment and
      retention procedures, effectiveness of randomization and blinding measures, and patient
      acceptability. Preliminary evaluation of the MBSR intervention will test for clinically
      reliable improvements in anxiety and depressive symptomatology following the intervention,
      relative to the Brain Health group, as well as improvements on a cognitive test battery. It
      is also predicted that changes associated with the MBSR intervention will still be present at
      the 3-month follow-up assessment as well. The final objective of the current proposal is an
      exploratory aim to determine whether the site of a patient's stroke plays a role in their
      ability to benefit from MBSR. Previous research has suggested that left prefrontal cortex
      plays a critical role underlying the effects of MBSR. Thus, patients with and without left
      prefrontal involvement will be compared, and it is predicted that involvement of this brain
      region will modulate the observed effects. Such information could be used to target those
      Veterans who can most benefit from the proposed intervention. If successful, the
      investigators plan to execute a larger efficacy study to evaluate the magnitude of treatment
      effects associated with MBSR. Alternative interventions such as MBSR can provide low-cost,
      non-invasive rehabilitative treatments for chronic stroke that can improve Veterans'
      functional recovery and general sense of well-being.
    

Intervention name(s): MBSR; Brain Health class
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.; An 8-week course on brain health will be administered to participants as an active control group.
Other intervention name(s): Meditation; Psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; depression; anxiety; mindfulness; meditation