Yoga for Mental Health in Parkinson's Patients

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05335850

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 baseline (T0), 6 weeks after the intervention (T2), 12 weeks after the intervention (T3), and 18 weeks after the intervention (T4). Compliance data will be collected weekly for 12 weeks for both groups.

Condition or Disease	Intervention/Treatment	Phase
Stress Anxiety Depression Parkinson Disease	Behavioral: Isha Kriya Behavioral: Nadi Shuddhi Behavioral: Nada Yoga Other: Routine Daily Activity	N/A

Detailed Description

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 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). This trial will be conducted in 2 phases:

Phase 1: If participants are in the intervention group, they will be asked to learn and practice a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga) for 12 weeks. They will be asked to complete a set of questionnaires at baseline (T0),6 weeks after the intervention (T2), 12 weeks after the intervention (T3), and 18 weeks after 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 the end of 7 weeks.

Phase 2: The waitlisted control group will begin the intervention at T2 and continue until T4 (12 weeks total). They will be asked to continue completing the questionnaires at the end of T2, T3, and T4. Both groups will be asked to complete a satisfaction survey at the end of T4.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Meditation and Breathing for Mental Health in Parkinson's Disease Patient

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).	Behavioral: 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. 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. Behavioral: Nada Yoga Nada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind.
Active Comparator: 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).	Other: 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.

Arm

Intervention/Treatment

Experimental: Intervention Group

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

Behavioral: 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.

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.

Behavioral: Nada Yoga

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

Active Comparator: 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).

Other: 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.

Outcome Measures

Primary Outcome Measures

Change in Compliance [For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.]
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 4 days of activity would be considered as compliant for that week.
Change in Anxiety [For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.]
Parkinson's Anxiety Scale (PAS) is a 12-item validated observer or patient-rated scale consisting of three subscales for persistent anxiety, episodic anxiety, and avoidance behavior in patients with Parkinson Disease. Participants are asked to rate on a scale of 0 (not or never) and 4 (severe or almost always).

Secondary Outcome Measures

Change in Perceived Stress Scale (PSS) [For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.]
PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.
Change in GRID-Hamilton Depression Scale (HAMD) [For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.]
The GRID-HAMD-17 is used to measure the frequency and intensity of depressive symptoms. Participants are asked to rate frequency of each statement on a scale from "Absent or clinically insignificant" to "Almost all the time." Rating for intensity is on a scale from Absent to Very Severe.
Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.]
This is a four-part survey designed for patients with Parkinson Disease. Part I covers non-motor experiences of daily living, Part II covers motor experiences of daily living, Part III covers motor examination and Part IV covers motor complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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