Anxiety, Depression, Emotional Adjustment, Low Vision, Stress, Visual Impairment
Conditions
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).
Interventions
BEHAVIORALMindful 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.
BEHAVIORALMusic 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
Sponsors
Anglia Ruskin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The participants will be randomised into two groups, mindful music or music listening in a 1:1 ratio using a randomisation software (https://www.randomizer.org/) and block randomisation to ensure equal distribution of groups between age and number of years living with a visual impairment. The researchers who are managing and running the study will not be blinded to the assignment of the groups. The participants will not be blinded to their allocated group, as participants would clearly know if they listened to their own preferred music alone or with mindfulness instructions. However, the researchers will blind the participants from the study hypothesis and which listening group is the control condition to minimise risk of bias.
Intervention model description
Feasibility and acceptability pre/post-test design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To identify reasons for motivation or barriers to adherence | Week 1 to Week 5 (Pre intervention to Post Intervention) | 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. |
| Accessibility of the intervention | Week 5 (Post 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. |
| Adherence to submission of a music listening diary log | Daily (Week 1 to Week 4) | Adherence to submission of the music listening diary log will be reported as the percentage of the participants who complete the diary log. |
| Treatment adherence at 4-weeks from baseline | Week 1 to Week 5 (Pre intervention to Post Intervention) | 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. |
| Feasibility of the intervention | At baseline to Week 5 (Pre to Post intervention) | Feasibility of the intervention will be reported as the percentage of participants who enrol and complete the entire study. |
| Attrition rate of the intervention | Week 5 (Post Intervention) | The percentage of recruited participants dropped out from the study prematurely |
| To understand the reasons for attrition rate of the intervention | Week 5 (Post 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. |
| Acceptability of the intervention | Week 5 (Post 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Anxiety levels | Baseline and Week 5 (Pre and Post Intervention) | 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. |
| Changes in Stress levels | Baseline and Week 5 (Pre and Post Intervention) | 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. |
| Changes in Depression levels | Baseline and Week 5 (Pre and Post Intervention) | 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. |
Countries
United Kingdom
Outcome results
None listed