Mindfulness Based Stress Reduction for Parkinson's Disease: A Longitudinal Study

Not Applicable

Completed

• Conditions: Parkinson's Disease; Mindfulness Based Stress Reduction; Quality of Life
• Interventions: Behavioral: Creative Education Care; Behavioral: Mindfulness Based Stress Reduction

• Registration Number: NCT03998462
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2020-01-01
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Creative Education Care	Creative Education Care	Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction	MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.

Primary Outcome Measures

Name	Time	Method
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index	0-9 weeks and 0-62 weeks	Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.
Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score	0-9 weeks and 0-62 weeks	Objective measure of executive function; range = 0-26; higher scores = better executive function
Change in State-Trait Anxiety Inventory (STAI) total score	0-9 weeks and 0-62 weeks	Measure of anxiety; range of possible scores from 20-80; "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States