Clinical trial NCT05442086: Music and ABS as a Potential Anxiety Intervention
Official title: Music and Auditory Beat Stimulation and Its Effect on Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety State
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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 a GAD-2 score of 1 or higher (indicating generalized anxiety) will be randomly assigned to a single 24-27 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), salivary cortisol, along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and music absorption (Absorption in Music Scale). 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.

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 50 participants with a GAD-2 score of 1 or more (indicating generalized 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 presented through earphones connected to a laptop. Upon arrival in the lab research staff will go over experimental expectations, and participants will be asked to fill out the Absorption in Music Scale (AIMS), the Positive and Negative Affect Scale (PANAS), and Self-Assessment Manikin (SAM), and the STICSA trait and state. They will also be asked if they take any medication or use any alternative techniques to manage their anxiety (Anxiety Coping Measures Questionnaire). 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 24-27 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. 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.

Eligibility criteria: Inclusion Criteria:

* GAD-2 score of 1 or higher indicating generalized anxiety.
* Age between 18-30 years
* Undergraduate student
* Comfortable speaking and understanding English
* Self-reported normal hearing

Exclusion Criteria:

* Self-reported history of cardiovascular conditions (e.g., arrhythmia, heart disease)
* History of seizures or epilepsy

Primary outcomes:
measure: Anxiety: EEG band power (alpha, beta, delta and theta bands)
timeFrame: 24-27 minutes
measure: Anxiety: Heart rate variability (HRV)
timeFrame: 24-27 minutes
measure: Anxiety: Stress hormone levels: Salivary cortisol
timeFrame: 24-27 minutes
measure: Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
timeFrame: 24-27 minutes
measure: Self-Assessment Manikin
timeFrame: 24-27 minutes
Secondary outcomes:
measure: Mood: Positive and Negative Affect Scale (PANAS)
timeFrame: 24-27 minutes
measure: Absorption in Music Scale (AIMS)
timeFrame: 24-27 minutes
measure: Anxiety Coping Measures
timeFrame: 24-27 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Metropolitan University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University (formerly Ryerson University)
name: Frank Russo, PhD
role: PRINCIPAL_INVESTIGATOR
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