Music and Auditory Beat Stimulation for Anxiety

Overseen By Kay Wright-Whyte, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Metropolitan University

Must be taking: Anxiety medication

Disqualifiers: Under 18, Cardiac issues, Epilepsy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 24 minutes

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it excludes people who are not taking anxiety medication. This suggests that you may need to continue your current anxiety medication to participate.

What data supports the effectiveness of the treatment Music and Theta Auditory Beat Stimulation for anxiety?

Research shows that music combined with auditory beat stimulation (ABS) in the theta frequency range can reduce anxiety. Studies have found that both monaural and binaural beat stimulation can positively affect mood and decrease anxiety levels. ^{1 2 3 4 5}

Is music and auditory beat stimulation safe for humans?

Music and auditory beat stimulation, including binaural and monaural beats, have been studied for their effects on anxiety and mood, and are generally considered safe for humans. Studies have shown positive effects on anxiety and mood without significant safety concerns. ^{1 2 4 5 6}

How is the Music and Theta Auditory Beat Stimulation treatment different from other anxiety treatments?

This treatment is unique because it combines calming music with auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz), which is a sound-based approach to reduce anxiety. Unlike traditional anxiety treatments that may involve medication or talk therapy, this method uses specific sound frequencies to potentially alter brainwave patterns and improve mood. ^{1 2 3 4 7}

Research Team

Frank Russo, PhD

Principal Investigator

Toronto Metropolitan University (formerly Ryerson University)

Eligibility Criteria

This trial is for individuals with mild anxiety, as indicated by a GAD-2 score of 1 or higher. Participants should have no known heart issues or epilepsy, moderate trait anxiety within specific ranges, and normal hearing.

Inclusion Criteria

I believe my hearing is normal.

I have no known heart problems.

I have never had epilepsy or seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a single 24-minute session of sound-based treatment with either music & ABS or pink noise

24 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety levels and physiological measures post-treatment

1-2 weeks

Treatment Details

Interventions

• Music and Theta Auditory Beat Stimulation
• Pink Noise

Trial Overview The study tests if calm music combined with Theta Auditory Beat Stimulation (ABS) can reduce anxiety more effectively than pink noise. It measures the effects using heart rate variability, EEGs, stress hormones like cortisol, and subjective anxiety assessments.

Participant Groups

Group I: Music and Theta Auditory Beat Stimulation Experimental Treatment 1 Intervention

Behavioural: Listening to calm music and auditory beat stimulation Participants will listen to calm music with theta auditory beat stimulation for 24-27 minutes

Group II: Pink Noise (control) Placebo Group 1 Intervention

Behavioural: Listening to pink noise Participants will listen to pink noise for 24 minutes

Who Is Running the Clinical Trial?

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

Ryerson University

Lead Sponsor

Trials

77

Recruited

7,800+

Findings from Research

In a study involving 163 participants taking anxiolytics, combining calm music with theta auditory beat stimulation (ABS) was found to significantly reduce both somatic and cognitive state anxiety, especially in those with moderate trait anxiety.

Participants with moderate trait anxiety experienced the greatest benefits from the combined treatment, while music alone also showed effectiveness compared to a control group, indicating that sound-based therapies can be a valuable tool for anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. Mallik, A., Russo, FA.[2022]

Monaural beat stimulation significantly reduced state anxiety in healthy participants, suggesting it could be an effective tool for anxiety management.

All tested monaural beat frequencies (theta, alpha, and gamma) showed positive effects on reducing anxiety compared to a control stimulus, indicating that different frequencies may be beneficial for emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Monaural Beat Stimulation on Anxiety and Cognition. Chaieb, L., Wilpert, EC., Hoppe, C., et al.[2020]

Auditory beat stimulation (ABS), particularly binaural beats, shows potential for influencing cognitive processes and mood states, suggesting it could be a useful tool in therapeutic settings.

The review highlights the importance of stimulation parameters in ABS, as variations can lead to contradictory findings in research outcomes, indicating that careful design of stimulation protocols is crucial for effective results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory beat stimulation and its effects on cognition and mood States. Chaieb, L., Wilpert, EC., Reber, TP., et al.[2022]

In a study involving 74 military service members with postdeployment stress, music embedded with binaural beat technology (BBT) significantly improved heart rate variability (HRV) compared to music alone, indicating a better stress response.

Participants using music with BBT reported lower stress levels over four weeks, suggesting that this intervention may effectively reduce both physical and psychological stress indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Binaural Beat Technology on the Cardiovascular Stress Response in Military Service Members With Postdeployment Stress. Gantt, MA., Dadds, S., Burns, DS., et al.[2018]

A pilot study involving 15 mildly anxious participants showed that listening to binaural beat tapes for 4 weeks significantly reduced daily anxiety scores, suggesting a potential therapeutic benefit.

Participants showed a preference for one specific tape with pronounced binaural beats, indicating that the characteristics of the audio may influence its effectiveness in reducing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Le Scouarnec, RP., Poirier, RM., Owens, JE., et al.[2007]

Binaural beat (BB) stimulation, specifically at 6 Hz, was found to significantly increase theta brain wave activity, which is associated with relaxation and sleep induction, in participants with subclinical insomnia after two weeks of use.

The study demonstrated that listening to music with BB not only enhanced theta power but also reduced beta power, indicating a decrease in hyper-arousal and potentially aiding in better sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entrapment of Binaural Auditory Beats in Subjects with Symptoms of Insomnia. Lee, E., Bang, Y., Yoon, IY., et al.[2022]

In a randomized controlled trial involving 170 emergency department patients, listening to purpose-designed music or sound compositions significantly reduced self-rated anxiety levels by 10%-15% compared to control groups that received no soundtrack or simulated ambient noise.

The most effective interventions included electroacoustic musical compositions and audio field recordings, both of which led to significant decreases in anxiety, highlighting the potential of sound therapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Original sound compositions reduce anxiety in emergency department patients: a randomised controlled trial. Weiland, TJ., Jelinek, GA., Macarow, KE., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Monaural Beat Stimulation on Anxiety and Cognition. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Auditory beat stimulation and its effects on cognition and mood States. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Effect of Binaural Beat Technology on the Cardiovascular Stress Response in Military Service Members With Postdeployment Stress. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Entrapment of Binaural Auditory Beats in Subjects with Symptoms of Insomnia. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Original sound compositions reduce anxiety in emergency department patients: a randomised controlled trial. [2019]