Plain English Summary
Background and study aims
Studies have shown that music can be used in a variety of contexts to reduce anxiety. While the relationship between music and anxiety reduction has been well researched and documented, there is still a need for a controlled study on the relationship between the length of musical treatment and the reduction in anxiety in order to improve the self-administration of musical interventions. A recent study found that music combined with auditory beat stimulation, relative to music alone, auditory beat stimulation alone or pink noise, was effective at reducing anxiety for individuals with moderate trait anxiety (anxiety as an everyday personality trait). This study seeks to replicate and extend these findings by examining whether the strength of the findings differs depending on the length of the combined music with auditory beat stimulation.
Who can participate?
Patients aged 18 years and over with moderate trait anxiety who were actively taking anxiolytics (medications that can treat anxiety symptoms)
What does the study involve?
Participants were randomly allocated to 12, 24, or 36 minutes of either music with auditory beat stimulation (treatment) or pink noise (control). Participants completed questionnaires before and after the treatment assessing state anxiety and affect.
What are the possible benefits and risks of participating?
This study is a minimal-risk study. However, participants may have felt some discomfort in responding to the questions. To mitigate this, participants were informed that their participation was voluntary and they were able to withdraw at any time. While there were no guaranteed benefits of participating in this study, participants may have experienced a reduction in their anxiety and contributed to the understanding of the relationship between music listening and anxiety relief.
Where is the study run from?
Goldsmith's, University of London (UK)
When is the study starting and how long is it expected to run for?
December 2022 to August 2023
Who is funding the study?
1. LUCID Therapeutics, the developers of the combined music and auditory beat stimulation treatment
2. Goldsmith's, University of London (UK)
Who is the main contact?
Prof. Lauren Stewart, l.stewart@gold.ac.uk
Study website
Contact information
Type
Public, Scientific, Principal Investigator
Contact name
Prof Lauren Stewart
ORCID ID
http://orcid.org/0000-0002-6221-6064
Contact details
Department of Psychology
Goldsmiths University of London
London
SE14 6NW
United Kingdom
+44 (0)7545173755
l.stewart@gold.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
PS130723DMS
Study information
Scientific title
Dose-response relationship between music and anxiety reduction
Acronym
DRMA
Study hypothesis
1. Those assigned to the music with auditory beat stimulation (ABS) treatment condition will experience a greater reduction in anxiety relative to those in the pink noise control condition.
2. The duration of music with ABS listened to will have differential effects on anxiety symptoms.
3. Those assigned to the 36-minute music with ABS treatment condition will experience a greater reduction in anxiety than those in the 12- or 24-minute music with ABS treatment conditions.
4. The findings of the present study will replicate those of Malik and Russo (2022).
Ethics approval(s)
Approved 13/07/2023, Goldsmiths, University of London Psychology Department Ethics Committee (8 Lewisham Way, London, SE14 6NW, United Kingdom; +44 (0)20 7919 7171; d.mullensiefen@gold.ac.uk), ref: PS130723DMS
Study design
Single-blind randomized control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Internet/virtual
Study type
Efficacy
Patient information sheet
Condition
Anxiety
Intervention
Participants are recruited and screened through prolific.com. In order to be eligible, participants must self-identify as taking anxiolytic medication and having moderate trait anxiety. Those eligible sign a consent form and are randomized to a condition and a dosage. The conditions are music with auditory beat stimulation (treatment condition) or pink noise (control condition). The dose variations will be listening to the audio for 12, 24, or 36 minutes. Participants will be randomized at a rate of 3:3 using the randomizer function on qualtrics.com.
Intervention type
Behavioural
Primary outcome measure
State Anxiety is measured using the State Trait Inventory for Cognitive and Somatic Anxiety at baseline and post-intervention (after 12, 24, or 36 minutes)
Secondary outcome measures
Affect measured using the Positive and Negative Affect Scale at baseline and post-intervention (after 12, 24, or 36 minutes)
Overall study start date
14/12/2022
Overall study end date
12/08/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Currently taking anxiolytics
2. Have moderate trait anxiety as defined by previously described State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) trait anxiety threshold scores
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Upper age limit
100 Years
Sex
Both
Target number of participants
120-160
Total final enrolment
144
Participant exclusion criteria
1. Do not meet the criteria for moderate trait anxiety
2. Not actively taking anxiolytic medication
Recruitment start date
17/07/2023
Recruitment end date
12/08/2023
Locations
Countries of recruitment
Australia, Brazil, Canada, Chile, Djibouti, England, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Northern Ireland, Poland, Portugal, Romania, Scotland, South Africa, Spain, United Kingdom, United States of America, Wales
Study participating centre
Goldsmiths' College
Goldsmiths College 8
Lewisham Way
London
SE14 6NW
United Kingdom
Sponsor information
Organisation
Goldsmiths University of London
Sponsor details
8
Lewisham Way
London
SE14 6NW
England
United Kingdom
+44 (0)72079197171
HoD.Psych@gold.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Industry
Funder name
Lucid Digital Therapeutics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Goldsmiths University of London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
01/08/2024
Individual participant data (IPD) sharing plan
The de-identified data that supports the findings of this study will be made available on the Open Science Framework.
The type of data stored: Participant responses to self-reports, including demographic information (nationality, type of medications currently taking) and raw scores on anxiety and affect questionnaires.
Dates of availability: From publication date
Informed consent was required and obtained for all participants.
IPD sharing plan summary
Stored in publicly available repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/05/2024 | No | Yes |