Music and ABS as a Potential Anxiety Intervention
- Conditions
- Anxiety State
- Interventions
- Behavioral: Music and Theta Auditory Beat StimulationBehavioral: Pink Noise (control)
- Registration Number
- NCT05442086
- Lead Sponsor
- Toronto Metropolitan University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- Self-reported history of cardiovascular conditions (e.g., arrhythmia, heart disease)
- History of seizures or epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music and Theta Auditory Beat Stimulation Music and Theta Auditory Beat Stimulation Behavioural: Listening to calm music and auditory beat stimulation Participants will listen to calm music with theta auditory beat stimulation for 24 minutes Pink Noise (control) Pink Noise (control) Behavioural: Listening to pink noise Participants listened to pink noise for 24 minutes
- Primary Outcome Measures
Name Time Method Anxiety: EEG band power (alpha, beta, delta and theta bands) 24-27 minutes EEG band power is a good objective physiological measure of anxiety and relaxation. It has good reliability and validity and has been used as an anxiety/relaxation measure in multiple studies (Aftanas, Pavlov, Reva, \& Varlamov, 2003; Gálvez, Recuero, Canuet, \& Del-Pozo, 2018; Knyazev, Savostyanov, \& Levin, 2005; Lee, Bhattacharya, Sohn, \& Verres, 2012; Tarrant, Viczko, \& Cope, 2018).
Anxiety: Heart rate variability (HRV) 24-27 minutes Heart rate variability is a good objective physiological measure of anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Chalmers, Quintana, Abbott, \& Kemp, 2014; Gorman \& Sloan, 2000; Licht, de Geus, van Dyck, \& Penninx, 2009; Pittig, Arch, Lam, \& Craske, 2013).
Anxiety: Stress hormone levels: Salivary cortisol 24-27 minutes Salivary cortisol is a good objective measure of stress and anxiety. It has good reliability and validity and has been used as an anxiety measure in multiple studies (Mantella et al., 2008; Vedhara et al., 2003; Vreeburg et al., 2010).
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) 24-27 minutes The State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) is a 21-item measure designed to measure somatic (11 items) and cognitive symptoms (10 items) of anxiety at both the trait and state levels. To differentiate between state and trait anxiety symptoms, participants will complete two versions of the measure, one where they rate how they "feel right now at this very moment" (STICSA-State) and one where they rate "how they feel in general" (STICSA-Trait). Respondents rate the degree to which each item is true for them on a Likert scale ranging from 1 = not at all to 4 = very much so. Scores on the STICSA can range from 10 - 40 (cognitive) or 11 - 44 (somatic), with higher scores indicating greater anxiety.
Self-Assessment Manikin 24-27 minutes Two series of Self-Assessment Manikins (SAM) will be administered to assess state emotional valence and arousal before and after the audio intervention. Participants will be asked to rate on two scales with accompanying images how they are feeling right now (unhappy to happy) and their energy levels from calm to excited both on a scale from 1-5. The pre-intervention SAM serves two purposes: the first, to assess baseline affect and the second, to select the playlist that the participant listens to if assigned to the audio intervention. The post-intervention SAM will serve to assess changes in affect following the intervention.
- Secondary Outcome Measures
Name Time Method Mood: Positive and Negative Affect Scale (PANAS) 24-27 minutes The PANAS has good reliability and validity and has been widely used in many studies to assess mood (Gray, 2007; Watson, Clark, \& Tellegen, 1988). 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.
Absorption in Music Scale (AIMS) 24-27 minutes The Absorption in Music Scale (AIMS) is a 34-item measure of individuals' ability and willingness to allow music to draw them into an emotional experience. The Absorption in Music Scale (AIMS) was administered post-intervention, after completing all other post-intervention measures to avoid biasing responses. The AIMS will serve as a sub-group analysis to assess if individuals who report higher absorption respond better to the audio intervention in the treatment condition. The AIMS demonstrates strong convergent validity with the Tellegen Absorption Scale (r = .76) and the Musical Involvement Scale (r = .74).
Anxiety Coping Measures 24-27 minutes This is a self-made questionnaire which asks whether the participant takes any anxiety medications, and about other coping strategies they may already employ.
Trial Locations
- Locations (1)
Toronto Metropolitan University
🇨🇦Toronto, Ontario, Canada