Skip to content

Development, Content Validation and Pilot Study Feasibility of Heartfulness Meditation and Yoga Protocol for Anxiety

Mansee Thakur

Research Square February 29, 2024 preprint DOI: 10.21203/rs.3.rs-3995680/v1 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Pilot study Randomized
Sample size 40
Population Individuals with low to moderate anxiety (pilot phase); 40 subject experts in yoga, Ayurveda, physiology, psychology, and psychiatry (validation phase)
Interventions relaxation cleaning
Measures Beck Anxiety Inventory (BAI), WHO-Well Being Index (WHO-WBI), Perceived Stress Scale (PSS)
Topics Anxiety Meditation
Key points The authors report that a Heartfulness Meditation and Yoga protocol was developed and validated, with all practices retained by 40 experts because content validity ratio scores exceeded 0.29. In the pilot study, participants reported 90% satisfaction, reduced anxiety, and improved well-being. The authors conclude the approach was safe, feasible, and effective, and call for randomized clinical trials.

Abstract

Integrating contemplative practices such as meditation and yoga may offer a comprehensive approach for the rise in mental health issues. We aimed to develop and validate a Heartfulness Meditation and Yoga protocol for individuals with low to moderate anxiety. In Phase 1, we developed the protocol from extensive literature survey using classical yoga texts and scientific studies. Phase 2 involved content validation through experts from fields related to yoga, Ayurveda, physiology, psychology, and psychiatry, by calculating the content validity ratio (CVR). Phase 3 consisted of a pilot study to check the feasibility and effectiveness of the protocol. Data were collected using Beck Anxiety Inventory (BAI), WHO-Well Being Index (WHO-WBI) and Perceived Stress Scale (PSS). The final protocol encompassed practices such meditation, relaxation, cleaning and pranayamas. In the validation phase, 40 subject experts participated, and all practices (for low and moderate anxiety) were incorporated in the final protocol, as CVR scores were >0.29. Participants from the pilot study revealed a high satisfaction rate of 90% and significant reduction in anxiety, and improved well-being. Our approach was safe, feasible and effective, making it a promising addition to conventional anxiety treatments. In future, randomized clinical trials are required. CTRI No. CTRI/2023/11/060151

Comparable studies

Other non-randomized and open-label trials on anxiety, most cited first.

Study Year Design Participants
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder Subjects with obsessive-compulsive disorder (OCD) 2006 Controlled clinical trial
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Emotions and brain function are altered up to one month after a single high dose of psilocybin. Healthy volunteers (7 female, 5 male) 2020 Open-label pilot study n = 12
Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study Older long-term AIDS survivor (OLTAS) self-identified gay men with moderate-to-severe... 2020 Open-label study

Citations in the library

Explore topics