Yoga for Mental Health in Parkinson's Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2024-09-25

Brief Summary

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This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups.

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Detailed Description

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Mental health issues caused by emotional and behavioral changes are common among people diagnosed with Parkinson's disease. Research from the Parkinson's Foundation's Parkinson's Outcomes Project has found that anxiety and depression play a key role in the disease's impact on people's quality of life. The death of dopamine-producing cells in the brain affects both movement and mood. As a result, both anxiety and depression are common non-motor symptoms of the disease rather than reactions to the diagnosis.

According to the Parkinson's Outcomes Project, during their illness:

* At least 50% of people will experience some form of depression
* At least 40% of people will experience an anxiety disorder

Forms of anxiety include Generalized Anxiety Disorder, Anxiety Attacks, Social Avoidance, and OCD1. Depression in Parkinson's disease often manifests as dissatisfaction with life, sadness, irritability, pessimism, and suicidal thoughts.

Meditative techniques have been shown to effectively reduce symptoms of anxiety and depression. Treating these non-motor symptoms can have a positive impact on people with Parkinson's disease by decreasing disability and improving their quality of life.

The purpose of this study is to investigate the impact of a set of simple, safe and scalable, digitally delivered meditation and breathing practices on the neuropsychological and movement disorder symptoms in patients with Parkinson's Disease over a period of 18-20 weeks. The intervention consists of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Our recent studies using similar interventions have shown feasibility and acceptance as well as Improved perceived stress in healthy subjects.

The subjects will be randomized into two groups after they agree to participate in the study, an intervention group (Group 1) and a waitlisted control group (Group 2). Both groups will learn and practice the intervention for 12 weeks total.The intervention is made of a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga). Both groups will also take study surveys at 4 timepoints which are each 6 weeks apart (Baseline, T2, T3, and T4). The study surveys consist of an online survey and a clinician, phone administered survey.

This trial will be conducted in 2 phases:

Phase 1: If participants are in the intervention group, they will be asked to learn the practices first for 6 weeks, from T1-T2. They will be asked to complete weekly activity logs for these 6 weeks and the study survey at T2 (6 weeks after learning the intervention). Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at T2 (6 weeks after Baseline). The waitlisted control group will also complete the study survey at T2.

Phase 2: After T2, the intervention group is no longer asked to attend weekly review webinars but they will continue to do weekly activity logs for 6 weeks until until T3. They will then complete the study survey at T3. After T3, they will not be sent any activity logs for the next 6 weeks until T4. At T4, they will be asked to complete the study survey and satisfaction survey. The waitlisted control group will begin the intervention at T2 and will attend review webinars for 6 weeks until T3 at which they will complete the study survey. After T3, they are no longer asked to attend weekly webinars but they will continue to do weekly activity logs for 6 weeks until until T4. At T4, they will be asked to complete the study survey and satisfaction survey.

Conditions

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Stress Anxiety Depression Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment A partial crossover model ensures that both experimental and waitlisted control group participants get to experience the effects of a proposed intervention. For our study, we are providing these practices as an intervention and both experimental and waitlisted control group participants get to experience the benefits of meditation and breathing exercises.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).

Group Type EXPERIMENTAL

Isha Kriya

Intervention Type BEHAVIORAL

Isha Kriya is a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily.

Nadi Shuddhi

Intervention Type BEHAVIORAL

Nadi Shuddhi is a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.

Nada Yoga

Intervention Type BEHAVIORAL

Nada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind.

Waitlisted Control Group

This group will be asked to wait for 6 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).

Group Type ACTIVE_COMPARATOR

Routine Daily Activity

Intervention Type OTHER

Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.

Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.

Interventions

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Isha Kriya

Isha Kriya is a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily.

Intervention Type BEHAVIORAL

Nadi Shuddhi

Nadi Shuddhi is a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.

Intervention Type BEHAVIORAL

Nada Yoga

Nada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind.

Intervention Type BEHAVIORAL

Routine Daily Activity

Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.

Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age above 18
* Interested in attending the Breath, Sound, and Meditation Webinar
* Diagnosed with Parkinson's Disease
* PAS score of 12 or higher
* Able to read and comprehend English.
* Physically and mentally able to participate in the study procedure
* Currently residing in the United States.

Exclusion Criteria

* Severe stage of PD
* Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
* Not able to self-consent to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes