Music and ABS as a Potential Anxiety Intervention

Study Overview
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Brief Summary
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Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been investigated in prior studies with subjective measures of anxiety. Here, the anxiety-reducing potential of calm music combined with theta ABS will be examined in a large sample of participants with objective psychophysiological measures (heart rate variability and EEG), stress hormone measures (salivary cortisol) along with subjective measures (STICSA state). Participants with moderate trait anxiety (n = 100) will be randomly assigned to a single 24-minute session of sound-based treatment: combined (music & ABS), or pink noise (control). Pre- and post-intervention heart rate variability and EEG band power (alpha, beta, delta, and theta bands), along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and musical preferences (Short Test of Music Preferences). Our hypothesis is that the music & ABS condition will have significantly higher EEG theta band activity and heart rate variability compared to the pink noise control condition. The investigators also expect to see significantly reduces higher state anxiety reduction in the music & ABS condition compared to the pink noise control condition. Participants with moderate trait anxiety (n = 100) will be randomly assigned to a single 24-minute session of sound-based treatment: combined (music & ABS), or pink noise (control). Pre- and post-intervention heart rate variability and EEG band power (alpha, beta, delta, and theta bands), along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and musical preferences (Short Test of Music Preferences). The investigators predict that the music & ABS condition will have significantly increased power in the theta and alpha bands, higher heart rate variability, higher state anxiety reduction, and lower salivary cortisol levels compared to the pink noise control condition.

Detailed Description
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In this study, the investigators will examine and compare the effectiveness of a combination of music and theta auditory beat stimulation (ABS) (as measured by the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)) compared to a control condition (pink noise). Prior work has demonstrated that ABS and music both reduce anxiety when presented on their own. It is hypothesized that music with ABS will lead to significantly lower anxiety levels and increased calmness compared to the pink noise control condition. Approximately 100 participants with moderate trait anxiety will be recruited from the greater Toronto area. The study will be conducted in the SMART lab at Toronto Metropolitan University and the experimental treatment will be provided with the LUCID Research App. Upon arrival in the lab research staff will go over experimental expectations, and participants will be asked to fill out the Short Test of Music Preferences (STOMP), the Positive and Negative Affect Scale (PANAS), and Self-Assessment Manikin (SAM), and the STICSA trait and state. They will also be asked to please list any medications you are taking, including marijuana and/or CBD. A baseline salivary cortisol sample will be taken from participants. Participants will then undergo EEG administration, assessment of spontaneous blink rate, and HRV, first obtaining a baseline level of these measures. EEG (alpha, beta, delta, and theta bands) will be recorded using the BioSemi EEG system via 64 scalp electrode sites according to the international 10-20 electrode system as done in a previous study examining EEG response to meditation. Linked mastoids will serve as a reference. Horizontal eye movements will be recorded using two electrodes placed 1 cm lateral to the outer canthi of each eye. Vertical eye movement potentials will be recorded using two electrodes placed in the center of the supraorbital and infraorbital regions of the left eye. These will be used to obtain the spontaneous blink rate of participants which is an analog of the sensitivity and responsiveness of the mesostriatal dopaminergic system that has in previous studies determined the degree to which gamma binaural beats affect cognition. Heart rate variability will also be recorded via the BioSemi system with two flat active electrodes attached to the participant's left and right wrists. Participants will then listen to their randomly assigned intervention for 24 minutes (music with theta ABS or pink noise). A post-intervention salivary cortisol sample will be taken along with a post-intervention EEG and HRV reading and the completion of the STICSA state anxiety questionnaire. An additional salivary cortisol sample will be taken 15 minutes after the end of the auditory treatment. If there are no significant pre-post differences in salivary cortisol levels between the treatment groups after collecting data from 50 participants, the investigators will cease collecting salivary cortisol. The investigators predict that the music & ABS condition will have significantly increased power in the theta and alpha bands compared to the pink noise control condition. The investigators also predict that the music & ABS condition will have higher heart rate variability compared to the pink noise control condition. The investigators also expect to see significantly higher state anxiety reduction and significantly lower salivary cortisol levels in the music & ABS condition compared to the pink noise control condition.

Official Title
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Music and Auditory Beat Stimulation and Its Effect on Anxiety

Conditions
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Anxiety State

Intervention / Treatment
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* Behavioral: Music and Theta Auditory Beat Stimulation
* Behavioral: Pink Noise (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate trait anxiety is defined by the following criteria: STICSA trait somatic score between 16.90 - 22.4 and STICSA trait cognitive score between 17.1-26.6 (Roberts et al. 2016). Self-identified normal hearing No known cardiac issues No known epilepsy/seizures Exclusion Criteria: Adults younger than 18 Not taking anxiety medication Have known cardiac issues Have known epilepsy/seizures Low or high trait anxiety as defined by the STICSA trait

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music and Theta Auditory Beat Stimulation<br>Behavioural: Listening to calm music and auditory beat stimulation Participants will listen to calm music with theta auditory beat stimulation for 24 minutes | Behavioral: Music and Theta Auditory Beat Stimulation<br>* Participants will listen to calm music with theta auditory beat stimulation for 24 minutes<br>|
| Sham Comparator: Pink Noise (control)<br>Behavioural: Listening to pink noise Participants listened to pink noise for 24 minutes | Behavioral: Pink Noise (control)<br>* Participants will listen to pink noise for 24 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety: EEG band power (alpha, beta, delta and theta bands) | EEG band power is a good objective physiological measure of anxiety and relaxation. It has good reliability and validity and has been used as an anxiety/relaxation measure in multiple studies (Aftanas, Pavlov, Reva, & Varlamov, 2003; Gálvez, Recuero, Canuet, & Del-Pozo, 2018; Knyazev, Savostyanov, & Levin, 2005; Lee, Bhattacharya, Sohn, & Verres, 2012; Tarrant, Viczko, & Cope, 2018). | 24 minutes | 
| Anxiety: Heart rate variability (HRV) | Heart rate variability is a good objective physiological measure of anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Chalmers, Quintana, Abbott, & Kemp, 2014; Gorman & Sloan, 2000; Licht, de Geus, van Dyck, & Penninx, 2009; Pittig, Arch, Lam, & Craske, 2013). | 24 minutes | 
| Anxiety: Stress hormone levels: Salivary cortisol | Salivary cortisol is a good objective measure of stress and anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Mantella et al., 2008; Vedhara et al., 2003; Vreeburg et al., 2010). | 24 minutes | 
| Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) | The STICSA has good reliability and validity as a measure of state and trait cognitive and somatic anxiety (Bados et al. 2010, Gros et al. 2007). The minimum score is 10 and the maximum is 40. Higher scores indicate higher anxiety (worse outcome). But in this study the post-intervention anxiety score is subtracted from the pre-intervention anxiety score, giving a measure of anxiety reduction. In the case of this anxiety reduction measure, higher anxiety reduction scores would indicate a better outcome. | 24 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood: Positive and Negative Affect Scale (PANAS) | The PANAS has good reliability and validity and has been widely used in many studies to assess mood (Gray, 2007; Watson, Clark, & Tellegen, 1988). This scale generates two scores: 1) Positive affect (higher score indicates a better outcome), scores range from 10-50. 2) Negative affect (higher score indicates worse outcome), scores range from 10-50. | 24 minutes |