NCT05171218

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 independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants. Participants taking anxiolytics (n = 163) were randomly assigned to a single 24-minute session of sound-based treatment: combined (music \& ABS), music-alone, ABS-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

November 27, 2021

Last Update Submit

January 5, 2022

Conditions

Anxiety

Keywords

AnxietyAuditory Beat StimulationBinaural BeatsMental HealthMusicNeurosciencePsychology

Outcome Measures

Primary Outcomes (1)

  • Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

    The State Trait Anxiety Inventory for Cognitive and Somatic Anxiety has good reliability and validity as a measure of state and trait cognitive and somatic anxiety. 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 Outcomes (1)

  • Mood: Positive and Negative Affect Scale (PANAS)

    24 minutes

Study Arms (4)

Music & Auditory Beat Stimulation

EXPERIMENTAL

Participants listened to calm music with theta auditory beat stimulation for 24 minutes

Behavioral: Music & Auditory Beat Stimulation

Music Alone

ACTIVE COMPARATOR

Participants listened to calm music for 24 minutes

Behavioral: Music Alone

Auditory Beat Stimulation

ACTIVE COMPARATOR

Participants listened to theta auditory beat stimulation for 24 minutes

Behavioral: Auditory Beat Stimulation

Pink Noise

SHAM COMPARATOR

Participants listened to pink noise for 24 minutes

Behavioral: Pink Noise

Interventions

Music & Auditory Beat StimulationBEHAVIORAL

Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes

Music & Auditory Beat Stimulation
Music AloneBEHAVIORAL

Listening to calm music Participants listened to calm music for 24 minutes

Music Alone
Auditory Beat StimulationBEHAVIORAL

Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes

Auditory Beat Stimulation
Pink NoiseBEHAVIORAL

Listening to pink noise Participants listened to pink noise for 24 minutes

Pink Noise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18+)
  • Must be taking anxiety medication
  • Self-identified normal hearing
  • No known cardiac issues
  • No known epilepsy/seizures
  • Have access to an iOS device (iPhone or iPad) to run the Research Application

You may not qualify if:

  • Adults younger than 18
  • Not taking anxiety medication
  • Have known cardiac issues
  • \- Do not have access to an iOS device (iPhone or iPad) to run the Research Application
  • Have known epilepsy/seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (12)

  • 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.

    PMID: 20954057BACKGROUND

  • Gray EK, Watson, D. Assessing positive and negative affect via self-report. In: Coan JA, Allen, J.J.B., editor. Handbook of emotion elicitation and assessment. New York, NY: Oxford University Press; 2007.

    BACKGROUND

  • 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.

    PMID: 18085930BACKGROUND

  • Phillips SP, Yu J. Is anxiety/depression increasing among 5-25 year-olds? A cross-sectional prevalence study in Ontario, Canada, 1997-2017. J Affect Disord. 2021 Mar 1;282:141-146. doi: 10.1016/j.jad.2020.12.178. Epub 2020 Dec 30.

    PMID: 33418360BACKGROUND

  • 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.

    PMID: 3397865BACKGROUND

  • Davis WB, Thaut MH. The Influence of Preferred Relaxing Music on Measures of State Anxiety, Relaxation, and Physiological Responses. Journal of Music Therapy. 1989;26(4):168-87. doi: 10.1093/jmt/26.4.168.

    BACKGROUND

  • 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.

    PMID: 28325532BACKGROUND

  • 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.

    PMID: 25452734BACKGROUND

  • 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.

    PMID: 16115248BACKGROUND

  • 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.

    PMID: 17309374BACKGROUND

  • Yusim A, Grigaitis J. Efficacy of Binaural Beat Meditation Technology for Treating Anxiety Symptoms: A Pilot Study. J Nerv Ment Dis. 2020 Feb;208(2):155-160. doi: 10.1097/NMD.0000000000001070.

    PMID: 31977827BACKGROUND

  • 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.

    PMID: 19388893BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Frank A Russo, PhD

    Toronto Metropolitan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment Participants taking anxiolytics (n = 163) were randomly assigned to a single 24- minute session of sound-based treatment: combined (Music with theta auditory beat stimulation), music-alone, theta auditory beat stimulation-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2021

First Posted

December 28, 2021

Study Start

July 9, 2020

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

We have registered the project on Open Science Framework and will make all elements of IPD open to the public. Please see: https://osf.io/efya2/ Study protocol and analysis plan: https://doi.org/10.17605/ OSF.IO/VHCA5 Consent form: https://osf.io/efya2/

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data are available now and will be for 7 years post data collection completion as per our REB approval: approximately January 2028
Access Criteria
There is no specific access criteria for the IPD on OSF. It is freely and openly available to anyone.
More information

Available IPD Datasets

Individual Participant Data Set Access
Study Protocol Access
Statistical Analysis Plan Access
Informed Consent Form Access

Locations

CA(1)