Anxiety Clinical Trial
Official title:
Sound Healing for Anxiety: A Randomized Controlled Trial
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
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Consciousness and Healing Initiative |
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Spoken Language | As measured by a spoken prompt that will be recorded | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 1-month post-intervention | |
Other | Microbiome changes | as measured by a microbiome sample | Baseline and 5 weeks | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Interoceptive awareness | as measured by the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) | Baseline, at 5 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | relationship with practitioner | as measured by a Practitioner Relationship questionnaire | at 1 week, 3 weeks, and 5 weeks | |
Secondary | depressive symptoms | as measured by the PHQ-9 | Baseline, at 3 weeks, 5 weeks and 1-month post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
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