Clinical trial NCT03998462: Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Official title: Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mindfulness Based Stress Reduction
Quality of Life
Keywords: Mindfulness
Parkinson's disease
Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-26
Enrollment: 108
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR),to improve HRQoL, cognition, and mood, as well as to determine the longevity of the treatment response in individuals with Parkinson's disease (PD).

Detailed description: Eligible study participants will be randomly assigned to one of two interventions: 1) Mindfulness Based Stress Reduction for Parkinson's disease; MBSR-PD or 2) Creative Education Care (CEC). Study visits may be held remotely, via online video format (Webex). Interventions are held within a group format consisting of approximately 6-10 individuals with PD. Groups will meet once per week for over a 9-week period. All participants will be administered a battery of neuropsychological tests to measure HRQoL, cognition (e.g., executive function, attention, memory), and mood (i.e., anxiety, depression, and apathy), as well as motor symptoms, disease severity, and mindfulness engagement/practice. Tests will be administered at baseline, 9 weeks (post-treatment), and 6- and 12-months (follow-up assessments) by an examiner blinded to group assignment.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of PD based on UK Brain Bank Criteria
2. \>40 years of age

Exclusion Criteria:

1. Secondary causes of Parkinsonism (e.g. corticobasal degeneration, progressive supranuclear palsy, drug-induced parkinsonism)
2. Other neurological conditions (e.g. stroke)
3. Clinical diagnosis of dementia based on any previous neuropsychological testing
4. Psychosis, antipsychotic treatment or treatment for substance abuse
5. Uncorrected vision or hearing to adequately participate in the intervention
6. Prior formal training in MBSR or regular current MBSR practice
7. Recent or new participation in a psychological/behavioral treatment, such as Cognitive Behavioral Therapy (CBT)
8. Active/current suicidal ideation

Primary outcomes:
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
timeFrame: 0-9 weeks and 0-62 weeks
measure: Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score
timeFrame: 0-9 weeks and 0-62 weeks
measure: Change in State-Trait Anxiety Inventory (STAI) total score
timeFrame: 0-9 weeks and 0-62 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Dawn M. Schiehser, PhD
role: PRINCIPAL_INVESTIGATOR
References: