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

VA Office of Research and Development

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Psychoeducational Supportive Care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03998462

D3154-R

Details and patient eligibility

About

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).

Full 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).

Enrollment: 107 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

107 participants in 2 patient groups

Mindfulness Based Stress Reduction (MBSR)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness Based Stress Reduction

Psychoeducational Supportive Care (PSC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducational Supportive Care