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Music and ABS as a Potential Anxiety Intervention

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ClinicalTrials.gov Identifier: NCT05442086
Recruitment Status : Not yet recruiting
First Posted : July 1, 2022
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Frank Russo, Ryerson University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety State Behavioral: Music and Theta Auditory Beat Stimulation Behavioral: Pink Noise (control) Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Music and Auditory Beat Stimulation and Its Effect on Anxiety
Estimated Study Start Date : August 15, 2022
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : October 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Noise

Arms and Interventions
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Arm Intervention/treatment
Experimental: Music and Theta Auditory Beat Stimulation
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
Participants will listen to calm music with theta auditory beat stimulation for 24 minutes
Sham Comparator: Pink Noise (control)
Behavioural: Listening to pink noise Participants listened to pink noise for 24 minutes
 Behavioral: Pink Noise (control)
Participants will listen to pink noise for 24 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety: EEG band power (alpha, beta, delta and theta bands) [ Time Frame: 24 minutes ]
    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).

  2. Anxiety: Heart rate variability (HRV) [ Time Frame: 24 minutes ]
    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).

  3. Anxiety: Stress hormone levels: Salivary cortisol [ Time Frame: 24 minutes ]
    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).

  4. Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [ Time Frame: 24 minutes ]
    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.


Secondary Outcome Measures :
  1. Mood: Positive and Negative Affect Scale (PANAS) [ Time Frame: 24 minutes ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05442086


Contacts
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Contact: Adiel Mallik, PhD 416-979-5000 ext 4989 adiel.mallik@ryerson.ca

Locations
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Canada, Ontario
Toronto Metropolitan University
Toronto, Ontario, Canada, M5B 2K3
Contact: George Chan, PhD    4169795000 ext 554989    george.chan@ryerson.ca   
Contact: Kay Wright-Whyte, MSc    41697950004989 ext 554989    kww@ryerson.ca   
Sponsors and Collaborators
Ryerson University
Investigators
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Principal Investigator: Frank Russo, PhD Toronto Metropolitan University (formerly Ryerson University)
More Information
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Publications:
Davis, W. B., & Thaut, M. H. (1989). The Influence of Preferred Relaxing Music on Measures of State Anxiety, Relaxation, and Physiological Responses. Journal of Music Therapy, 26(4), 168-187. doi:10.1093/jmt/26.4.168
Gray, E. K., Watson, D. (2007). Assessing positive and negative affect via self-report. In J. A. Coan, Allen, J.J.B. (Ed.), Handbook of emotion elicitation and assessment. New York, NY: Oxford University Press.

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Responsible Party: Frank Russo, Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT05442086    
Other Study ID Numbers: REB 2020-068EEG1
First Posted: July 1, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual de-identified participant data for EEG band power, Heart rate variability (HRV), salivary cortisol, STICSA state anxiety, and PANAS measures will be shared on the Open Science Framework.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available on the Open Science Framework (osf.io) when the pre-print of the study is uploaded to PsyArXiv. After that point the data will be available for a period of 5 years.
Access Criteria: All supporting information will be publicly accessible on the Open Science Framework (osf.io).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders