Anxiety, Anxiety Generalized, Anxiety State, Mental Health Issue
Conditions
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.
Interventions
OTHERBiofield tuning
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.
Sponsors
Consciousness and Healing Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Once randomized, the participants will know they are receiving the intervention. Outcomes assessor will be masked for data analysis.
Intervention model description
Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety 1-month | 1-month post-intervention | We also aim to understand how long BT intervention effects may last with a 1-month follow up as measured by the STAI. |
| Positive and Negative Affect | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention | as measured by the Positive and Negative Affect Scale-Short Form (PANAS) |
| Interoceptive awareness | Baseline, at 5 weeks | as measured by the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) |
| mental health recovery | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 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. |
| stress | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 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. |
| relationship with practitioner | at 1 week, 3 weeks, and 5 weeks | as measured by a Practitioner Relationship questionnaire |
| depressive symptoms | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | as measured by the PHQ-9 |
| self compassion | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | 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. |
| perceived social support | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention | as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Spoken Language | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention | As measured by a spoken prompt that will be recorded |
| Microbiome changes | Baseline and 5 weeks | as measured by a microbiome sample |
Contacts
Primary ContactLorna C Ciccone, ND
Backup ContactChloe Tanega
Outcome results
None listed