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

Quality of Life Clinical Trial

— MBSR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03998462
• Other study ID #: D3154-R
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness Based Stress Reduction
• Parkinson Disease
• Parkinson's Disease
• Quality of Life

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index	Parkinson's disease Quality of Life (self-report); range = 0-156. Higher scores = poorer quality of life.	0-9 weeks and 0-62 weeks
Primary	Change in Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test total score	Objective measure of executive function; range = 0-26; higher scores = better executive function	0-9 weeks and 0-62 weeks
Primary	Change in State-Trait Anxiety Inventory (STAI) total score	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).	0-9 weeks and 0-62 weeks