RecruitingACTRN12623000406606

The hearables study - addressing mental health in hearing impaired older adults through the use of hearable devices and behavioural activation (BA) therapy.

Impact of Hearables & BA on Mental Distress and Social Isolation in Hearing Impaired Older Adults

Sponsor

University of Western Australia

Enrollment

240 participants

Start Date

Jun 28, 2023

Study Type

Interventional

Conditions

Poor quality of life Depression

Summary

Hearing loss is prevalent in later life and associated with increased risk of depression, social isolation, loneliness, mental illness and reduced quality of life. Additionally, the Covid-19 pandemic has brought about restrictions in social interaction and face to face contact, which has further impacted on the social isolation and mental health status of adults, particularly those with hearing loss. Treatment of hearing loss can be relatively simple but traditional hearing aids are expensive and uptake is often sub-optimal. Personal sound amplification products (PSAPs - 'hearables') offer a simple, cost-effective alternative to conventional hearing aids, but no current evidence exists to determine if they improve the psychosocial consequences of age-related HL. Psychological therapies can be effective in treating mental distress in the elderly but factors such as availability of suitably trained therapists, cost and difficulties delivering the therapy in a socially isolated, hearing-impaired population pose challenges. Behavioural activation (BA) is a pragmatic and fairly simple psychological intervention aimed at improving mental health by increasing cognitive, physical and social activities. BA has been shown to be effective in treating depression in the general population but no current evidence exists to determine if BA with or without hearing loss treatment is effective in ameliorating the psychosocial consequences of hearing loss. The proposed project will aim to test if hearing amplification with PSAPs with or without a BA intervention program improves mood, relieves mental distress and social isolation, improves quality of life, and reduces health care costs in older adults with hearing loss. We will utilise a 2x2 factorial design to randomise 240 older adults aged 65 years and older with mild-moderate hearing loss to a 6-month clinical trial of hearing amplification and/or BA compared with an education intervention control group.

Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Hearing loss is very common in older adults and is strongly linked to social isolation, depression, and reduced quality of life. Traditional hearing aids can help enormously but are expensive and many people do not use them consistently. Personal sound amplification products (PSAPs or 'hearables') are a much cheaper and more accessible alternative. At the same time, psychological approaches like Behavioural Activation (BA) — which works by gradually increasing meaningful and enjoyable activities to lift mood — can address the social and emotional consequences of hearing loss. This six-month clinical trial is testing two interventions — hearable devices and a BA therapy program — both separately and in combination, against an education-only control group. The study is enrolling 240 older adults aged 65 and over who have mild to moderate hearing loss and mild depression symptoms, to see whether these practical, accessible interventions can improve mental health and social connection. You may be eligible if you are 65 or older, have a mild to moderate hearing loss, are experiencing some depression symptoms (PHQ-9 score of 5–9), do not currently use hearing aids, and are able to read, understand, and speak English. People with severe hearing loss, significant cognitive impairment, or active suicidal thoughts would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This trial is a 2x2 factorial design trial. Groups and descriptions are outlined below. Hearing Amplification (Group 1 arm 1) Participants who meet eligibility criteria for the study will be gifte

This trial is a 2x2 factorial design trial. Groups and descriptions are outlined below. Hearing Amplification (Group 1 arm 1) Participants who meet eligibility criteria for the study will be gifted and fitted (at baseline) with personal sound amplification devices which have been approved by both the National Disability Insurance Scheme (NDIS) and Australian Hearing Services Program-Assistive Listening Devices category. The devices will be fitted by a member of the research team or audiologist and will take around 15 minutes. A follow-up appointment will be set for 2 weeks to program the devices based on user experiences. The follow up fitting appointment will also take 15 minutes. During this time participants will also complete baseline (BL) assessments through a self-administered questionnaire with the following assessments: Patient Health Questionnaire (PHQ-9) Generalised Anxiety Index (GAI) Hearing Handicap Inventory for Elderly (HHIE) Luben Social Network Loneliness Scale Function comorbidity Instrumental Activities of Daily Living (IADL) Frailty assessment (Fried) Medical History Demographics Total appointment time for participants will be 90 minutes. Follow up assessments including a hearing assessment to monitor adherence will occur at 12 & 26 weeks from baseline. Behavioural Activation (Group 2 arm 2) This program will utilise trained research BA therapists who will work directly with participants to promote goal setting and the implementation of action plans designed to reinforce the practice of healthy and rewarding activities. We will adapt our previously developed 8-step behavioural BA program to treat and prevent depression in later life with an emphasis on increasing cognitive, physical and social activity. The 8 one-on-one BA sessions will follow a validated structured program that has been shown to deliver benefits to older adults in the community. These sessions will address: Recognition of the symptoms of hearing and cognitive loss on activities, Recognising symptoms of depression & low mood The value of keeping a diary Types of activities Breaking jobs down The benefits of activities, Finding ways to be active, Spotting symptoms of depression Action plan The BA therapist will use these principles to encourage participants to enhance their daily routine activities, reduce avoidant behaviours and increase pleasurable behaviours. Activities will be tailored to meet the needs of participants and their living environment. Action plans will be written and include clear step-by step sequences to compensate for cognitive and hearing deficits. The program will be delivered once per week for a total period of up to 12 weeks with each session lasting up to 60 minutes. (whilst there are 8 stages an additional 4 weeks have been provided to account for sickness and other absences). The BA therapist will work through a self-help workbook with participants supporting them in identifying activities that are meaningful and add value. The workbook provides examples related to breaking activities down and adding them to their daily life to engage them in valued activities and set goals. Each participant will attend a BA appointment with the therapist either face to face or video chat once a week last up to 60 minutes. These sessions will be documented on a fidelity document that will be completed by the BA therapist and reviewed in the next session. Participants will complete the self-administered questionnaire which includes the assessments outlined in group 1 arm 1 at weeks 12 and 26. HA & BA (Group 3 arm 3) Those randomised to both HA & BA will have the personal sound amplification device fitted first and receive the BA workbook at the 2-week fitting check-up appointment. (after completing baseline assessments) Appointments will be made with participants to commence BA within 7 days of completing BL. Follow up hearing and self-administered questionnaire assessments will also take place at 12 and 26 weeks. Control Participants will complete a hearing and self-administered questionnaire assessment at baseline, 12 and 26 weeks.