Yoga for Mental Health in Parkinson's Patients

NCT05335850 | Completed

• 1 other identifier: 2022P000212
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Anxiety; Depression; Parkinson Disease

Keywords

Stress; Anxiety; Depression; Parkinson's Disease; Meditation; Breathing; Isha Kriya; Yoga; Mental Health

Outcome Measures

Primary Outcomes (2)

• 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.

  For Phase 1 analysis: Baseline to week 6. For Phase 2 analysis: Baseline to week 18.

• 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).

  For Phase 1 analysis: Baseline to week 12. For Phase 2 analysis: Baseline to week 18.

Secondary Outcomes (3)

• Change in Perceived Stress Scale (PSS)

  For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.

• Change in GRID-Hamilton Depression Scale (HAMD)

  For Phase 1 analysis: Baseline to 6 weeks. For Phase 2 analysis: Baseline to 18 weeks.

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Isha Kriya; Behavioral: Nadi Shuddhi; Behavioral: Nada Yoga

Waitlisted Control Group

ACTIVE COMPARATOR

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

Interventions

Isha Kriya 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.

Intervention Group

Nadi Shuddhi 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.

Intervention Group

Nada Yoga BEHAVIORAL

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

Intervention Group

Routine Daily Activity 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.

Waitlisted Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 32665843 BACKGROUND

• 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.

  PMID: 33935886 BACKGROUND

• 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.

  PMID: 34977549 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parkinson Disease; Respiratory Aspiration; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Balachundar Subramaniam, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 19, 2022
• Study Start: October 18, 2022
• Primary Completion: September 12, 2024
• Study Completion: September 25, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)