The Effects of Music & Auditory Beat Stimulation on Anxiety

NCT ID: NCT05171218

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2021-02-02

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).

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music & Auditory Beat Stimulation

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

Group Type: EXPERIMENTAL

Music & Auditory Beat Stimulation

Intervention Type: BEHAVIORAL

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

Music Alone

Participants listened to calm music for 24 minutes

Group Type: ACTIVE_COMPARATOR

Music Alone

Intervention Type: BEHAVIORAL

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

Auditory Beat Stimulation

Participants listened to theta auditory beat stimulation for 24 minutes

Group Type: ACTIVE_COMPARATOR

Auditory Beat Stimulation

Intervention Type: BEHAVIORAL

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

Pink Noise

Participants listened to pink noise for 24 minutes

Group Type: SHAM_COMPARATOR

Pink Noise

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Music Alone

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

Intervention Type: BEHAVIORAL

Auditory Beat Stimulation

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

Intervention Type: BEHAVIORAL

Pink Noise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lucid, Inc.

INDUSTRY

Sponsor Role: collaborator

Mitacs

INDUSTRY

Sponsor Role: collaborator

Toronto Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Frank Russo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A Russo, PhD

Role: STUDY_DIRECTOR

Toronto Metropolitan University

Locations

Ryerson University

Toronto, Ontario, Canada

Countries

Canada

References

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Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Study Documents

Document Type: Individual Participant Data Set

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Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

REB 2020-068

Identifier Type: -

Identifier Source: org_study_id