Clinical trial NCT05171218: The Effects of Music & Auditory Beat Stimulation on Anxiety
Official title: The Effects of Music & Auditory Beat Stimulation on Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Auditory Beat Stimulation
Binaural Beats
Mental Health
Music
Neuroscience
Psychology
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Lucid, Inc.
name: Mitacs
First posted: 2021-12-28
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
timeFrame: 24 minutes
Secondary outcomes:
measure: Mood: Positive and Negative Affect Scale (PANAS)
timeFrame: 24 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Frank A Russo, PhD
role: STUDY_DIRECTOR
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