Clinical trial NCT05243732: Music Listening for Wellbeing in Adults With Acquired Visual Impairment
Official title: Music Listening for Psychological and Emotional Wellbeing in Adults With Acquired Visual Impairment: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Low Vision
Depression
Anxiety
Stress
Emotional Adjustment
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility and acceptability pre/post-test design
Primary purpose: OTHER

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: At baseline to Week 5 (Pre to Post intervention)
measure: Attrition rate of the intervention
timeFrame: Week 5 (Post Intervention)
measure: To understand the reasons for attrition rate of the intervention
timeFrame: Week 5 (Post Intervention)
measure: Acceptability of the intervention
timeFrame: Week 5 (Post Intervention)
measure: Accessibility of the intervention
timeFrame: Week 5 (Post Intervention)
measure: Adherence to submission of a music listening diary log
timeFrame: Daily (Week 1 to Week 4)
measure: Treatment adherence at 4-weeks from baseline
timeFrame: Week 1 to Week 5 (Pre intervention to Post Intervention)
measure: To identify reasons for motivation or barriers to adherence
timeFrame: Week 1 to Week 5 (Pre intervention to Post Intervention)
Secondary outcomes:
measure: Changes in Depression levels
timeFrame: Baseline and Week 5 (Pre and Post Intervention)
measure: Changes in Anxiety levels
timeFrame: Baseline and Week 5 (Pre and Post Intervention)
measure: Changes in Stress levels
timeFrame: Baseline and Week 5 (Pre and Post Intervention)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Department of Vision and Hearing Sciences
Study officials:
affiliation: Anglia Ruskin University
name: Nurbanu Somani, MSc MRes BSc
role: PRINCIPAL_INVESTIGATOR
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