Clinical trial NCT06100406: Sound Healing for Anxiety: A Randomized Controlled Trial
Official title: Sound Healing for Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Mental Health Issue
Anxiety Generalized
Anxiety State
Lead sponsor: Consciousness and Healing Initiative
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention versus waitlist control. The control group will have the option to receive the intervention after the study is completed.
Primary purpose: TREATMENT

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.

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.).

Primary outcomes:
measure: Anxiety
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks
Secondary outcomes:
measure: Anxiety 1-month
timeFrame: 1-month post-intervention
measure: Positive and Negative Affect
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention
measure: Interoceptive awareness
timeFrame: Baseline, at 5 weeks
measure: mental health recovery
timeFrame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
measure: stress
timeFrame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
measure: self compassion
timeFrame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
measure: perceived social support
timeFrame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
measure: relationship with practitioner
timeFrame: at 1 week, 3 weeks, and 5 weeks
measure: depressive symptoms
timeFrame: Baseline, at 3 weeks, 5 weeks and 1-month post-intervention
Other outcomes:
measure: Spoken Language
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention
measure: Microbiome changes
timeFrame: Baseline and 5 weeks
Locations:
Study officials:
affiliation: Consciousness and Healing Initiative
name: Shamini Jain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Hemal H Patel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Cassandra Vieten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jain S, Hammerschlag R, Mills P, Cohen L, Krieger R, Vieten C, Lutgendorf S. Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations. Glob Adv Health Med. 2015 Nov;4(Suppl):58-66. doi: 10.7453/gahmj.2015.034.suppl. Epub 2015 Nov 1.
citation: Jain S, McKusick E, Ciccone L, Sprengel M, Ritenbaugh C. Sound healing reduces generalized anxiety during the pandemic: A feasibility study. Complement Ther Med. 2023 Jun;74:102947. doi: 10.1016/j.ctim.2023.102947. Epub 2023 Apr 5.