Music Listening for Wellbeing in Adults With Acquired Visual Impairment

Depression Clinical Trial

Official title:

Music Listening for Psychological and Emotional Wellbeing in Adults With Acquired Visual Impairment: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243732
• Other study ID #: 1021-07
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A visual impairment (VI) is often associated with reduced psychological wellbeing. Music can be used in a variety of ways to promote psychological wellbeing. Music intervention studies demonstrate that listening to music can provide a distraction from unpleasant thoughts/feelings. Hence, music may serve as a catalyst to improve mood and relieve feelings of depression, anxiety, and stress.

The purpose of this study is to investigate if it is feasible for people with acquired VI to self-deliver daily music listening (music alone or with mindful music listening instructions) for wellbeing, in participants homes, for four-weeks, and to collect data remotely on efficacy in reducing symptoms of anxiety and depression and treatment fidelity.

Description:

Detailed Description:

As part of the study participants will be asked to:

• listen to music online at home (for example streaming music using Apple Music, Spotify or the provider participants have an existing account with) for up to one-hour each day, five days a week for four-weeks.

• complete a listening diary log each day (10 minutes duration approximately). This provides an opportunity for participants to record their feelings and emotions after every listening exercise.

• complete surveys to capture evaluative information before and after the four-weeks music listening trial.

• part take in a series of one-to-one consultations via Zoom/MS Teams (video optional) on creating a personalised playlist for each participant, technical and instructional training and follow up progress.

• optional one-to-one interview via Zoom/MS Teams (video optional) on feedback and experience of this daily music listening research study (10 minutes duration approximately).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 1, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18+

• Have an acquired vision loss (someone who was not born with vision loss but lost part or all of their vision later in life)

• Have an existing account on a online streaming platform to listen to music

• Own a smartphone/tablet or technology that supports their music streaming platform

• Have the capacity to consent

• Have at least mild symptoms on the Depression Anxiety Stress Scale (DASS-21) screening questionnaire; depression (score: 10 or higher on a scale 0-28+) and/or anxiety (score: 8 or higher on a scale 0-20+) and/or stress (score: 15 or higher on a scale 0-34+)

Exclusion Criteria:

• Anyone who has a hearing impairment that renders the individual unable to listen to music or mindfulness instructions and follow a conversation on the telephone.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Emotional Adjustment
• Low Vision
• Stress
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• Mindful Music Listening
Participants will be instructed to self-administer this intervention daily, five days a week, for four weeks, 20 to 60 minutes per day at any time that is convenient for them. During the intervention period, participants will be recommended to listen to music in a private setting that is quiet, where they will not be disturbed or distracted so they can fully focus on the music. Participants in the mindful listening group will be given specific instructions on how to listen and follow mindfulness.
• Music Listening
Participants will be instructed to self-administer this intervention daily, five days a week, for four weeks, 20 to 60 minutes per day at any time that is convenient for them. During the intervention period, participants will be recommended to listen to music in a private setting that is quiet, where they will not be disturbed or distracted so they can fully focus on the music. No other specific music listening instructions will be given

Locations

Country	Name	City	State
United Kingdom	Department of Vision and Hearing Sciences	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (12)

Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev. 2011 Oct;35(9):1989-99. doi: 10.1016/j.neubiorev.2011.06.005. Epub 2011 Jun 16. — View Citation

Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898. — View Citation

Broman AT, Munoz B, Rodriguez J, Sanchez R, Quigley HA, Klein R, Snyder R, West SK. The impact of visual impairment and eye disease on vision-related quality of life in a Mexican-American population: proyecto VER. Invest Ophthalmol Vis Sci. 2002 Nov;43(11):3393-8. — View Citation

Brown RL, Barrett AE. Visual impairment and quality of life among older adults: an examination of explanations for the relationship. J Gerontol B Psychol Sci Soc Sci. 2011 May;66(3):364-73. doi: 10.1093/geronb/gbr015. Epub 2011 Mar 14. — View Citation

Chanda ML, Levitin DJ. The neurochemistry of music. Trends Cogn Sci. 2013 Apr;17(4):179-93. doi: 10.1016/j.tics.2013.02.007. — View Citation

Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury Eye Evaluation. Ophthalmology. 2008 Feb;115(2):233-8. doi: 10.1016/j.ophtha.2007.04.050. Epub 2007 Jul 26. — View Citation

Linnemann A, Ditzen B, Strahler J, Doerr JM, Nater UM. Music listening as a means of stress reduction in daily life. Psychoneuroendocrinology. 2015 Oct;60:82-90. doi: 10.1016/j.psyneuen.2015.06.008. Epub 2015 Jun 21. — View Citation

Matthews K, Nazroo J, Whillans J. The consequences of self-reported vision change in later-life: evidence from the English Longitudinal Study of Ageing. Public Health. 2017 Jan;142:7-14. doi: 10.1016/j.puhe.2016.09.034. Epub 2016 Nov 10. — View Citation

Mojon-Azzi SM, Sousa-Poza A, Mojon DS. Impact of low vision on well-being in 10 European countries. Ophthalmologica. 2008;222(3):205-12. doi: 10.1159/000126085. Epub 2008 May 22. — View Citation

Rafaely L, Carmel S, Bachner YG. Subjective well-being of visually impaired older adults living in the community. Aging Ment Health. 2018 Sep;22(9):1223-1231. doi: 10.1080/13607863.2017.1341469. Epub 2017 Jun 21. — View Citation

Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10. — View Citation

Senra H, Macedo AF, Nunes N, Balaskas K, Aslam T, Costa E. Psychological and Psychosocial Interventions for Depression and Anxiety in Patients With Age-Related Macular Degeneration: A Systematic Review. Am J Geriatr Psychiatry. 2019 Aug;27(8):755-773. doi: 10.1016/j.jagp.2019.03.001. Epub 2019 Mar 7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	Feasibility of the intervention will be reported as the percentage of participants who enrol and complete the entire study.	At baseline to Week 5 (Pre to Post intervention)
Primary	Attrition rate of the intervention	The percentage of recruited participants dropped out from the study prematurely	Week 5 (Post Intervention)
Primary	To understand the reasons for attrition rate of the intervention	Qualitative methods will be utilised to identify reasons the recruited participants dropped out from the study prematurely via free text comment boxes on the evaluation survey and optional semi-structured interviews.	Week 5 (Post Intervention)
Primary	Acceptability of the intervention	Acceptability will be defined as participant's evaluation of the online intervention using both qualitative and quantitative methods. The acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and score it 5 being "acceptable" in contrast to 1 being "unacceptable" on a 5-point researcher devised Likert scale. Feedback on the overall intervention will be collated through free text comment boxes on the evaluation survey and optional semi-structured interviews.	Week 5 (Post Intervention)
Primary	Accessibility of the intervention	Accessibility will be defined as participant's evaluation of the online intervention using both qualitative and quantitative methods. The accessibility of the intervention will be reported as the percentage of participants who evaluated the intervention, and score it 5 being "very easy" in contrast to 1 being "very difficult" to use on a 5-point researcher devised Likert scale. To identify the accessibility barriers, free text comment boxes on the evaluation survey will be utilised and optional semi-structured interviews.	Week 5 (Post Intervention)
Primary	Adherence to submission of a music listening diary log	Adherence to submission of the music listening diary log will be reported as the percentage of the participants who complete the diary log.	Daily (Week 1 to Week 4)
Primary	Treatment adherence at 4-weeks from baseline	Treatment adherence will be reported as the percentage of the participants who complete all aspects of the study, i.e. diary log submissions, all music exercises.	Week 1 to Week 5 (Pre intervention to Post Intervention)
Primary	To identify reasons for motivation or barriers to adherence	Qualitative methods will be utilised to identify reasons for motivation or barriers to adherence using free text comment boxes on the evaluation survey and optional semi-structured interviews.	Week 1 to Week 5 (Pre intervention to Post Intervention)
Secondary	Changes in Depression levels	Depression will be self-rated by participants using the Hospital Anxiety and Depression Scale (HADS). This is assessed on a scale 0-21, below 7 indicates normal levels, 8-10 means borderline abnormal and 11-21 infers abnormal levels of depression.	Baseline and Week 5 (Pre and Post Intervention)
Secondary	Changes in Anxiety levels	Anxiety will be self-rated by participants using the Hospital Anxiety and Depression Scale (HADS). This is assessed on a scale 0-21, below 7 indicates normal levels, 8-10 means borderline abnormal and 11-21 infers abnormal levels of anxiety.	Baseline and Week 5 (Pre and Post Intervention)
Secondary	Changes in Stress levels	Stress will be self-rated by participants using the Perceived Stress Scale (PSS-14). This is assessed on a scale 0 to 40. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.	Baseline and Week 5 (Pre and Post Intervention)