What side effects are associated with this type of intervention?

Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR) and mindfulness-based cognitive therapy (MBCT), are generally safe and well-tolerated, with few reported side effects. Cognitive behavioral therapy (CBT) for insomnia and anxiety in Parkinson's Disease (PD) patients has shown possible benefits with minimal adverse effects. Exercise interventions, including resistance training and cardiovascular training, have been found to improve sleep and mobility in PD patients, with no significant side effects reported. Overall, these non-pharmacological treatments are considered safe and effective for managing stress, anxiety, and mobility issues in PD.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily include pharmacological options such as levodopa, dopamine agonists (e.g., pramipexole, ropinirole, rotigotine), and MAO-B inhibitors. These treatments focus on managing motor symptoms. Non-pharmacological approaches, like the mindfulness-based walking intervention, are less commonly FDA-approved but are gaining attention for their potential benefits in reducing stress and anxiety. While specific mindfulness-based therapies are not FDA-approved, they are being studied for their holistic benefits in improving mental health and quality of life in Parkinson's patients.

What other types of research exist?

Promising alternatives to Mindfulness-Based Walking Intervention for PD patients include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown benefits for sleep and overall quality of life; 2) Bright Light Therapy, which can improve sleep and reduce daytime sleepiness; 3) Exercise interventions, particularly those involving moderate to maximal intensity, which improve both subjective and objective sleep measures; 4) Melatonin, which is effective for insomnia and sleep quality in PD patients; 5) Yoga Meditation, which enhances proprioception and balance without adverse events.

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Behavioral Intervention

Mindful Walking for Parkinson's Disease (MM-RCT Trial)

N/A

Waitlist Available

Led By Gammon Earhart, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Summary

This trial will test a new therapy called Mindfulness-Based Walking Therapy (MBWT) for people with Parkinson's disease who have trouble walking. The therapy combines walking exercises with mindfulness techniques to help reduce stress and anxiety. By being more aware of their thoughts and feelings, patients may improve their ability to walk smoothly.

Who is the study for?

This trial is for people over 55 with Parkinson's disease who experience freezing of gait (FOG), a condition that hinders normal stepping. Participants must be diagnosed by a neurologist, have a history of FOG, and can walk independently for at least five minutes. They should not have dementia, be planning deep brain surgery soon, or have other medical issues that would limit safe participation.

What is being tested?

The study compares Mindfulness Based Walking Therapy (MBWT) to an educational program about FOG in individuals with Parkinson's. MBWT aims to reduce stress and improve mobility by increasing awareness and self-compassion. The effectiveness will be measured through this randomized controlled trial.

What are the potential side effects?

Since the interventions involve mindfulness practices and education without medications or invasive procedures, significant side effects are not expected. However, participants may experience emotional discomfort when discussing their experiences with FOG.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence: Number of Hours Participants Practice Mindfulness at Home

Attendance of Participants: Number of Participants at Each Session

Recruitment of Sample: Number of Participants Recruited

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mindfulness-Based Walking Therapy (MBWT)Experimental Treatment1 Intervention

Participants will receive the MBWT intervention.

Group II: Freezing of Gait (FOG) EducationPlacebo Group1 Intervention

Participants will receive educational materials about FOG and track their usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Based Walking Therapy (MBWT)

2022

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include nonpharmacological approaches like mindfulness-based interventions and exercise. Mindfulness-based treatments, such as the Mindfulness-Based Walking Intervention, work by reducing stress and anxiety through increased conscious awareness and self-compassion. This is important for PD patients as it helps manage significant non-motor symptoms, improving mental health and quality of life. Exercise interventions, including walking, enhance motor functions like gait and balance, which are essential for maintaining mobility and independence. By addressing both mental and physical aspects, these treatments offer a comprehensive approach to managing PD.

Stay mindfully active during the coronavirus pandemic: a feasibility study of mHealth-delivered mindfulness yoga program for people with Parkinson's disease.Prioritising target non-pharmacological interventions for research in Parkinson's disease: achieving consensus from key stakeholders.Stress and Mindfulness in Parkinson's Disease: Clinical Effects and Potential Underlying Mechanisms.