The Effect of Iso-Principal Based Music Playlists on Anxiety

July 27, 2022 updated by: Frank Russo, Ryerson University
Chronic anxiety is a growing psychological challenge worldwide and at pre-clinical levels, can be disabling. Some research suggests music may reduce anxiety symptoms as effectively as anti-anxiety drugs without the adverse side effects. The iso principle suggests that the effectiveness of music interventions for mood management can be maximized by commencing a session with music that matches an individual's current emotional state and then gradually moving toward their desired emotional state. Our previous work demonstrated that a playlist generated by a music recommendation system that uses the iso-principal, along with music informatics, auditory beat stimulation, and reinforcement learning can reduce somatic and cognitive anxiety. However, it is unknown whether music playlists based on the iso-principal alone can reduce anxiety. In this study, the investigators wish to examine whether music playlists (~30 min long) based on the iso-principal (neutral to calm) will reduce anxiety after anxiety induction compared to a calm music playlist. The investigators hypothesize that the iso-principal playlist will have greater state anxiety reduction compared to the calm playlist.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic anxiety is a growing psychological challenge worldwide and at pre-clinical levels, can be disabling. Some research suggests music may reduce anxiety symptoms as effectively as anti-anxiety drugs without the adverse side effects. The iso principle suggests that the effectiveness of music interventions for mood management can be maximized by commencing a session with music that matches an individual's current emotional state and then gradually moving toward their desired emotional state. Our previous work demonstrated that a playlist generated by a music recommendation system that uses the iso-principal, along with music informatics, auditory beat stimulation, and reinforcement learning can reduce somatic and cognitive anxiety. However, it is unknown whether music playlists based on the iso-principal alone can reduce anxiety. In this study, the investigators wish to examine whether music playlists (~30 min long) based on the iso-principal (neutral to calm) will reduce anxiety after anxiety induction compared to a calm music playlist. The investigators hypothesize that the iso-principal playlist will have greater state anxiety reduction compared to the reverse-iso and calm playlists. Participants (n = 100) will be recruited and randomly assigned to one of three groups 1) Iso principal playlist, 2) Calm playlist. Prior to their treatment, all participants will undergo anxiety induction (recall an anxiety-provoking event, while listening to anxiety-inducing music). State anxiety (STICSA), positive and negative affect (PANAS), arousal, and valence (SAM) will be measured pre-post anxiety induction and after treatment. This work will be the first of its kind to examine whether a playlist based on the iso-principal is effective at reducing anxiety.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who have no hearing impairments
  • Participants who have no cardiac issues.
  • Participants who have no history of seizures and epilepsy.

Exclusion Criteria:

  • Participants who have hearing impairments
  • Participants who have cardiac issues.
  • Participants who have a history of seizures and epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iso-principle music playlist
Participants listen to the iso-principle music playlist for 30 minutes.
Behavioral: Iso-principle music playlist
Participants listen to the iso-principle music playlist for 30 minutes.
Sham Comparator: Generic calm music playlist
Participants listen to the generic music playlist for 30 minutes.
Behavioral: Generic calm music playlist
Participants listen to the calm music playlist for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time Frame: 30 minutes
The STICSA has good reliability and validity as a measure of state and trait cognitive and somatic anxiety (Bados et al. 2010, Gros et al. 2007). The minimum score is 10 and the maximum is 40. Higher scores indicate higher anxiety (worse outcome). But in this study the post-intervention anxiety score is subtracted from the pre-intervention anxiety score, giving a measure of anxiety reduction. In the case of this anxiety reduction measure, higher anxiety reduction scores would indicate a better outcome.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood: Positive and Negative Affect Scale (PANAS)
Time Frame: 30 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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Investigators

  • Principal Investigator: Frank Russo, PhD, Toronto Metropolitan University
  • Study Director: Adiel Mallik, PhD, Toronto Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2022

Primary Completion (Anticipated)

August 15, 2022

Study Completion (Anticipated)

August 15, 2022

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB2020-068ISO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual de-identified participant data for STICSA state anxiety, PANAS, and SAM measures will be shared on the Open Science Framework.

IPD Sharing Time Frame

Data will become available on the Open Science Framework (osf.io) when the pre-print of the study is uploaded to PsyArXiv. After that point the data will be available for a period of 5 years.

IPD Sharing Access Criteria

All supporting information will be publicly accessible on the Open Science Framework (osf.io).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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