The Effects of Music & Auditory Beat Stimulation on Anxiety

Sponsor
Ryerson University (Other)
Overall Status
Completed
CT.gov ID
NCT05171218
Collaborator
Lucid, Inc. (Industry), Mitacs (Industry)
163
1
4
6.8
23.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music & Auditory Beat Stimulation
  • Behavioral: Music Alone
  • Behavioral: Auditory Beat Stimulation
  • Behavioral: Pink Noise
N/A

Detailed Description

In this study, the investigators examined and compared the effectiveness of ABS in the theta range, calm music playlist curated by an affective music recommendation system, and the combination of ABS and the same music to reduce anxiety and stress levels (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 other experimental conditions. Approximately 163 participants were recruited from the Prolific online participant pool (https://www.prolific.co). The experiment was conducted on the Qualtrics survey platform, and the experimental treatment was provided with the LUCID Research App. After reading and agreeing with the consent form, participants provided their Prolific ID and then filled out the Short Test of Music Preferences (STOMP), Queen's Music Questionnaire, Anxiety coping method's questionnaire, Positive and Negative Affect Scale (PANAS), Self-Assessment Manikin (SAM), Eysenck Personality Questionnaire, and the State Trait Inventory of Cognitive and Somatic Anxiety (STICSA). Participants were also asked to list any medications currently being taken (including cannabis). Participants were then randomly assigned to one of four treatment groups: (1) music; (2) music and auditory beat stimulation (ABS); (3) auditory beat stimulation (ABS) alone; or (4) pink noise for 24 minutes. Participants then received instructions on how to download the LUCID Research app on their iOS device or access the LUCID Research App through a virtual machine using their computer. Participants listened to their randomly assigned treatment for 24 minutes. Participants then completed their post-intervention questionnaires which included: the STICSA state version, SAM and PANAS. The investigators' hypotheses were that the combined, music alone and ABS alone conditions would experience a greater reduction in somatic and cognitive state anxiety compared to the pink noise control condition. These hypotheses were pre-registered using the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/VHCA5) and were based upon previous studies showing that ABS and music listening are capable of reducing anxiety. The investigators had no specific predictions for moderate and high trait anxiety participants, but their pre-registration noted their intention to recruit from both of these populations.

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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).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).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Music & Auditory Beat Stimulation on Anxiety
Actual Study Start Date :
Jul 9, 2020
Actual Primary Completion Date :
Feb 2, 2021
Actual Study Completion Date :
Feb 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music & Auditory Beat Stimulation

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

Behavioral: Music & Auditory Beat Stimulation
Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes

Active Comparator: Music Alone

Participants listened to calm music for 24 minutes

Behavioral: Music Alone
Listening to calm music Participants listened to calm music for 24 minutes

Active Comparator: Auditory Beat Stimulation

Participants listened to theta auditory beat stimulation for 24 minutes

Behavioral: Auditory Beat Stimulation
Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes

Sham Comparator: Pink Noise

Participants listened to pink noise for 24 minutes

Behavioral: Pink Noise
Listening to pink noise Participants listened to pink noise for 24 minutes

Outcome Measures

Primary Outcome Measures

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

    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.

Secondary Outcome Measures

  1. Mood: Positive and Negative Affect Scale (PANAS) [24 minutes]

    The Positive and Negative Affect Scale has good reliability and validity and has been widely used in many studies to assess mood. 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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ryerson University Toronto Ontario Canada M5B 2K3

Sponsors and Collaborators

  • Ryerson University
  • Lucid, Inc.
  • Mitacs

Investigators

  • Study Director: Frank A Russo, PhD, Ryerson University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Frank Russo, Professor, Ryerson University
ClinicalTrials.gov Identifier:
NCT05171218
Other Study ID Numbers:
  • REB 2020-068
First Posted:
Dec 28, 2021
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frank Russo, Professor, Ryerson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022