Sound Healing for Anxiety: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized controlled trial is to compare a novel sound healing approach, biofield tuning, to a waitlist control group in a healthy adult population naive to the intervention. The main questions it aims to answer are: Is there a significant reduction in state and trait anxiety as measured by the State-Trait Anxiety Index (STAI) with biofield tuning compared to waitlist control? Are there significant reductions in negative affect, as well as increases in self-compassion, positive affect, and interoceptive awareness in the intervention group? What are the relationships between changes in anxiety symptoms, negative affect words, and microbiome changes in participants who have undergone this biofield intervention? Participants will be: Randomized to intervention/control Recieve 5 sound healing interventions weekly Asked to complete surveys and audio prompts throughout the intervention Asked to provide a microbiome sample pre- and post-intervention

Detailed Description
-----------------
There is an increasing rate of anxiety among the US population, without adequate amounts of resources for treatment. Current pharmacological and psychological treatments for generalized anxiety disorder delivered by doctors, nurses, and clinical psychologists are often expensive and not freely available for many who need effective interventions for anxiety. A novel sound healing approach, Biofield Tuning (BT), has suggested potential benefits to those suffering from generalized anxiety. This intervention, while requiring training and certification, allows for holistic health practitioners to treat anxiety as a complementary mind-body therapy for those seeking relief for anxiety. Intervention. BT is a non-invasive, non-medical therapeutic practice developed by Eileen Day McKusick. BT Practitioners use a tuning fork to identify off-the-body sites at which perturbations in the tuning fork sound are detected. Such sites are described by BT practitioners as storing health-related information within the human biofield. Practitioners describe the process of BT as assessing and clearing perturbations in the human biofield to foster healing. Previous Feasibility Study. Our initial cohort study showed that conducting research for this novel sound healing approach online was feasible and suggested clinical benefits for people struggling with moderate to severe generalized anxiety, as noted in our peer-reviewed scientific publication. This RCT is designed to build upon the previous cohort study by comparing this intervention with a control group to further determine the effectiveness of BT compared to treatment as usual.

Official Title
-----------------
Sound Healing for Anxiety: A Randomized Controlled Trial

Conditions
-----------------
Mental Health Issue, Anxiety Generalized, Anxiety State, Anxiety

Intervention / Treatment
-----------------
* Other: Biofield tuning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older (≥ 18) Biofield-tuning naive (have never had a session of biofield tuning before) Speak and understand English at a native level Have a score ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale Have regular access to a computer Have experience using a computer Be comfortable using Zoom and completing data collection activities online and over the phone Exclusion Criteria: Suffering from any severe psychological, physical, or cognitive disease or impairment. An active diagnosis or history of suicidality, Post-Traumatic Stress Disorder (PTSD), schizophrenia, or psychotic disorders. This includes history or current suicidality, suicide ideation, and intent to harm self or others. Women who are pregnant or nursing. Having an electronically implanted device, excluding cochlear implants. Currently seeking treatment for an active cancer. Currently has an untreated serious illness (e.g. heart disease, diabetes, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Biofield Tuning is a non-invasive, non-medical therapeutic practice in which a resonating tuning fork is used to identify and re-balance off-the-body sites at which perturbations in the tuning fork sound are detected. The description of the intervention has been provided by Biofield Tuning Practitioners and thus describes the practitioner's experience and process while performing the intervention. For this study, the Biofield Tuning practitioner will be using a hologram of the participant's body since the intervention will be performed remotely. A hologram is when a BT practitioner imagines the body of the participant on the table in front of them. This approach was used successfully for our last feasibility study suggesting an impact of the virtually delivered BT intervention on anxiety. | Other: Biofield tuning<br>* Biofield Tuning is a non-invasive, non-medical therapeutic practice in which a resonating tuning fork is used to identify and re-balance off-the-body sites at which perturbations in the tuning fork sound are detected.<br>* Other names: sound healing;|
| No Intervention: Waitlist control<br>The waitlist control group will complete the same weekly self-report questionnaires outlined in the protocol as the intervention group and weekly audio recordings. Following their one-month follow-up questionnaire, those in the waitlist group will be offered a BT session at no cost. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The main objective is to assess whether virtually-delivered biofield tuning can significantly reduce moderate to high levels of generalized anxiety as measured by the State Trait Anxiety Index (STAI). | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety 1-month | We also aim to understand how long BT intervention effects may last with a 1-month follow up as measured by the STAI. | 1-month post-intervention | 
| Positive and Negative Affect | as measured by the Positive and Negative Affect Scale-Short Form (PANAS) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention | 
| Interoceptive awareness | as measured by the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) | Baseline, at 5 weeks | 
| mental health recovery | as measured by the Recovery Assessment Scale- Revised (RAS-r). Scores range from 24 to 120. Items are rated from 1 to 5. Higher scores indicate higher levels of recovery. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 
| stress | as measured by the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 
| self compassion | as measured by the Self-Compassion Scale-Short Form (SCS-SF). The total score is an overall indication of self-compassion, with a higher score indicating more self-compassion. | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 
| perceived social support | as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 
| relationship with practitioner | as measured by a Practitioner Relationship questionnaire | at 1 week, 3 weeks, and 5 weeks | 
| depressive symptoms | as measured by the PHQ-9 | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |