- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442086
Music and ABS as a Potential Anxiety Intervention
July 27, 2022 updated by: Frank Russo, Ryerson University
Music and Auditory Beat Stimulation and Its Effect on Anxiety
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- Toronto Metropolitan University
-
Contact:
- George Chan, PhD
- Phone Number: 554989 4169795000
- Email: george.chan@ryerson.ca
-
Contact:
- Kay Wright-Whyte, MSc
- Phone Number: 554989 41697950004989
- Email: kww@ryerson.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
Participants will listen to pink noise for 24 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
24 minutes
|
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).
|
24 minutes
|
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).
|
24 minutes
|
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.
|
24 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Russo, PhD, Toronto Metropolitan University (formerly Ryerson University)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
- Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.
- Aftanas LI, Pavlov SV, Reva NV, Varlamov AA. Trait anxiety impact on the EEG theta band power changes during appraisal of threatening and pleasant visual stimuli. Int J Psychophysiol. 2003 Nov;50(3):205-12. doi: 10.1016/s0167-8760(03)00156-9.
- Bados A, Gomez-Benito J, Balaguer G. The state-trait anxiety inventory, trait version: does it really measure anxiety? J Pers Assess. 2010 Nov;92(6):560-7. doi: 10.1080/00223891.2010.513295.
- Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.
- 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
- Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
- Gorman JM, Sloan RP. Heart rate variability in depressive and anxiety disorders. Am Heart J. 2000 Oct;140(4 Suppl):77-83. doi: 10.1067/mhj.2000.109981.
- 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.
- Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.
- Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.
- Jongkees BJ, Colzato LS. Spontaneous eye blink rate as predictor of dopamine-related cognitive function-A review. Neurosci Biobehav Rev. 2016 Dec;71:58-82. doi: 10.1016/j.neubiorev.2016.08.020. Epub 2016 Aug 21.
- Knyazev GG, Savostyanov AN, Levin EA. Uncertainty, anxiety, and brain oscillations. Neurosci Lett. 2005 Oct 28;387(3):121-5. doi: 10.1016/j.neulet.2005.06.016.
- Lagopoulos J, Xu J, Rasmussen I, Vik A, Malhi GS, Eliassen CF, Arntsen IE, Saether JG, Hollup S, Holen A, Davanger S, Ellingsen O. Increased theta and alpha EEG activity during nondirective meditation. J Altern Complement Med. 2009 Nov;15(11):1187-92. doi: 10.1089/acm.2009.0113.
- Lee EJ, Bhattacharya J, Sohn C, Verres R. Monochord sounds and progressive muscle relaxation reduce anxiety and improve relaxation during chemotherapy: a pilot EEG study. Complement Ther Med. 2012 Dec;20(6):409-16. doi: 10.1016/j.ctim.2012.07.002. Epub 2012 Aug 23.
- Licht CM, de Geus EJ, van Dyck R, Penninx BW. Association between anxiety disorders and heart rate variability in The Netherlands Study of Depression and Anxiety (NESDA). Psychosom Med. 2009 Jun;71(5):508-18. doi: 10.1097/PSY.0b013e3181a292a6. Epub 2009 May 4.
- Luque-Casado A, Perakakis P, Ciria LF, Sanabria D. Transient autonomic responses during sustained attention in high and low fit young adults. Sci Rep. 2016 Jun 8;6:27556. doi: 10.1038/srep27556.
- Mantella RC, Butters MA, Amico JA, Mazumdar S, Rollman BL, Begley AE, Reynolds CF, Lenze EJ. Salivary cortisol is associated with diagnosis and severity of late-life generalized anxiety disorder. Psychoneuroendocrinology. 2008 Jul;33(6):773-81. doi: 10.1016/j.psyneuen.2008.03.002. Epub 2008 Apr 14.
- McConnell PA, Froeliger B, Garland EL, Ives JC, Sforzo GA. Auditory driving of the autonomic nervous system: Listening to theta-frequency binaural beats post-exercise increases parasympathetic activation and sympathetic withdrawal. Front Psychol. 2014 Nov 14;5:1248. doi: 10.3389/fpsyg.2014.01248. eCollection 2014.
- Pittig A, Arch JJ, Lam CW, Craske MG. Heart rate and heart rate variability in panic, social anxiety, obsessive-compulsive, and generalized anxiety disorders at baseline and in response to relaxation and hyperventilation. Int J Psychophysiol. 2013 Jan;87(1):19-27. doi: 10.1016/j.ijpsycho.2012.10.012. Epub 2012 Oct 27.
- Reedijk SA, Bolders A, Hommel B. The impact of binaural beats on creativity. Front Hum Neurosci. 2013 Nov 14;7:786. doi: 10.3389/fnhum.2013.00786. eCollection 2013.
- Reedijk SA, Bolders A, Colzato LS, Hommel B. Eliminating the Attentional Blink through Binaural Beats: A Case for Tailored Cognitive Enhancement. Front Psychiatry. 2015 Jun 4;6:82. doi: 10.3389/fpsyt.2015.00082. eCollection 2015.
- Roberts KE, Hart TA, Eastwood JD. Factor structure and validity of the State-Trait Inventory for Cognitive and Somatic Anxiety. Psychol Assess. 2016 Feb;28(2):134-146. doi: 10.1037/pas0000155. Epub 2015 May 25.
- Tarrant J, Viczko J, Cope H. Virtual Reality for Anxiety Reduction Demonstrated by Quantitative EEG: A Pilot Study. Front Psychol. 2018 Jul 24;9:1280. doi: 10.3389/fpsyg.2018.01280. eCollection 2018.
- Vedhara K, Miles J, Bennett P, Plummer S, Tallon D, Brooks E, Gale L, Munnoch K, Schreiber-Kounine C, Fowler C, Lightman S, Sammon A, Rayter Z, Farndon J. An investigation into the relationship between salivary cortisol, stress, anxiety and depression. Biol Psychol. 2003 Feb;62(2):89-96. doi: 10.1016/s0301-0511(02)00128-x.
- Vreeburg SA, Zitman FG, van Pelt J, Derijk RH, Verhagen JC, van Dyck R, Hoogendijk WJ, Smit JH, Penninx BW. Salivary cortisol levels in persons with and without different anxiety disorders. Psychosom Med. 2010 May;72(4):340-7. doi: 10.1097/PSY.0b013e3181d2f0c8. Epub 2010 Feb 26.
- Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 15, 2022
Primary Completion (ANTICIPATED)
October 10, 2022
Study Completion (ANTICIPATED)
October 10, 2022
Study Registration Dates
First Submitted
June 28, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (ACTUAL)
July 1, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 2020-068EEG1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing 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.
IPD Sharing Access Criteria
All supporting information will be publicly accessible on the Open Science Framework (osf.io).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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