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

NCT ID: NCT03998462

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-11-01

Brief Summary

To investigate the efficacy of Mindfulness-based Stress Reduction (MBSR) to improve quality of life, 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 with PD were randomly assigned to one of two 9-week remote (online) interventions: 1) Mindfulness Based Stress Reduction (MBSR) or 2) Psychoeducational Supportive Care (PSC). Intervention groups consisted of approximately 6-9 individuals and met weekly for 2.5 hours x 8 weeks and for 4 hours ("retreat") during week 7. All participants were remotely administered a battery of neuropsychological tests to measure quality of life, 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 at pre-intervention (baseline), post-intervention (9 weeks), and at 6- and 12-months (follow-up assessments).

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness Based Stress Reduction (MBSR)

Individuals with Parkinson's disease were randomly assigned to one of two study arms: MBSR or PSC. The MBSR intervention was based on the standard program developed by Jon Kabat-Zinn (1990). It consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour retreat during week 7. Due to the COVID-19 pandemic, all MBSR sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Group Type: ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

MBSR used in this trial was based on the standard program developed by Jon Kabat-Zinn (1990). It consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour retreat during week 7. Due to the COVID-19 pandemic, the MBSR sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Psychoeducational Supportive Care (PSC)

Individuals with Parkinson's disease were randomly assigned to one of two study arms: MBSR or PSC. PSC is a novel intervention developed by Schiehser and colleagues to serve as a control for MBSR in this trial. PSC was modeled after common support/education groups that provide support and psychoeducation about Parkinson's disease available in the community. PSC consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour "retreat" during week 7. Due to the COVID-19 pandemic, all sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Group Type: ACTIVE_COMPARATOR

Psychoeducational Supportive Care

Intervention Type: BEHAVIORAL

PSC is a novel intervention developed by Schiehser and colleagues to provide psychoeducation about Parkinson's disease and supportive group care. PSC consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour "retreat" during week 7. Due to the COVID-19 pandemic, all sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Interventions

Mindfulness Based Stress Reduction

MBSR used in this trial was based on the standard program developed by Jon Kabat-Zinn (1990). It consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour retreat during week 7. Due to the COVID-19 pandemic, the MBSR sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Intervention Type: BEHAVIORAL

Psychoeducational Supportive Care

PSC is a novel intervention developed by Schiehser and colleagues to provide psychoeducation about Parkinson's disease and supportive group care. PSC consisted of weekly 2.5 hours sessions x 8 weeks and one 4-hour "retreat" during week 7. Due to the COVID-19 pandemic, all sessions were conducted completely online with randomized groups of 6-9 individuals with PD and were led by a trained instructor who was not involved in the clinical care or assessment of the participants.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR; PSC

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of PD based on UK Brain Bank Criteria

2. 40 years of age or older

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. Inability to use a computer or technology for participation

8. Active/current suicidal ideation

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn M. Schiehser, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego Veterans Healthcare System

Locations

VA San Diego Healthcare System

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D3154-R

Identifier Type: -

Identifier Source: org_study_id