Yoga for Mental Health in Parkinson's Patients
Primary Purpose
Stress, Anxiety, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isha Kriya
Nadi Shuddhi
Nada Yoga
Routine Daily Activity
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Stress, Anxiety, Depression, Parkinson's Disease, Meditation, Breathing, Isha Kriya, Yoga, Mental Health
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Waitlisted Control Group
Arm Description
Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).
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).
Outcomes
Primary Outcome Measures
Change in Compliance
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
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)
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)
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)
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.
Full Information
NCT ID
NCT05335850
First Posted
April 6, 2022
Last Updated
November 15, 2022
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05335850
Brief Title
Yoga for Mental Health in Parkinson's Patients
Official Title
Meditation and Breathing for Mental Health in Parkinson's Disease Patient
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 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.
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 18-20 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression, Parkinson Disease
Keywords
Stress, Anxiety, Depression, Parkinson's Disease, Meditation, Breathing, Isha Kriya, Yoga, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).
Arm Title
Waitlisted Control Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Isha Kriya
Intervention Description
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
Intervention Name(s)
Nadi Shuddhi
Intervention Description
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
Intervention Name(s)
Nada Yoga
Intervention Description
Nada Yoga is a 6-minute meditation that uses sound to create balance and stability in the body and mind.
Intervention Type
Other
Intervention Name(s)
Routine Daily Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Compliance
Description
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.
Time Frame
For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.
Title
Change in Anxiety
Description
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).
Time Frame
For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
Secondary Outcome Measure Information:
Title
Change in Perceived Stress Scale (PSS)
Description
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.
Time Frame
For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Title
Change in GRID-Hamilton Depression Scale (HAMD)
Description
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.
Time Frame
For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.
Title
Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balachundar Subramaniam, MD, MPH
Phone
6176672721
Email
sadhgurucenter_research@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sepideh Hariri, PhD
Email
sadhgurucenter_research@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balachundar Subramaniam, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Centre
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balachundar M Subramaniam
Phone
617-667-2721
Email
sadhgurucenter_research@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Balachundar Subramaniam, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32665843
Citation
Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
Results Reference
background
PubMed Identifier
33935886
Citation
Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
Results Reference
background
PubMed Identifier
34977549
Citation
Schneider RB, Auinger P, Tarolli CG, Iourinets J, Gil Diaz MC, Richard IH. Change in the Parkinson Anxiety Scale correlates with change in other clinical measures of anxiety over time. Clin Park Relat Disord. 2021 Dec 13;6:100126. doi: 10.1016/j.prdoa.2021.100126. eCollection 2022.
Results Reference
background
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Yoga for Mental Health in Parkinson's Patients
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