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

Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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 Inde X(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 so CONDITION: Depression ;Social isolation;Hearing loss;Poor quality of life; ; Depression ; Social isolation ; Hearing loss ; Poor quality of life Ear ‐ Other ear disorders Mental Health ‐ Depression Mental Health ‐ Other mental health disorders Mental Health ‐ Studies of normal psychology, cognitive function and behaviour PRIMARY OUTCOME: Changes in mood assessed through the Patient Health Questionnaire ‐ 9 (PHQ‐9) ; [Baseline ‐ pre intervention, 12 weeks ‐ primary time point, 26 weeks ‐ post commencement of intervention.] Hearing loss ‐ assessed through Hearing Handicap Inventory for Elderly and Kuduwave hearing assessment.[Baseline ‐ pre intervention, 12 weeks ‐ primary time point, 26 weeks ‐ post commencement of intervention] INCLUSION CRITERIA: Aged 65 and older Score 5 – 9 (inclusive) on the Patient Health Questionnaire (PHQ‐9) i.e. sub‐syndromal depression Do not currently use hearing aids or HA devices Be competent in written and spoken English Hearing handicap score > 20% on self‐assessment of communication or > 8 on the Hearing Handicap Inventory of the Elderly (HHIE) Be willing to provide consent for participation SECONDARY OUTCOME: Anxiety ‐ measured through the General Anxiety Index[Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention] Changes in health care costs ‐ assessed through a self administered questionnaire titled Health Care Utilisation Cost Questionnaire. The questionnaire has been validated and is awaiting publication.[Baseline ‐ pre intervention, 12 weeks , 26 weeks ‐ post commencement of intervention] Comorbidity ‐ measuring physical comorbidities through FCI[Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention] Frailty measured through the Fried Frailty Assessment[Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention] Quality of life and independence ‐ measured through Instrumental Activities of Daily Living (IADL) [Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention] Social Isolation ‐ measured through the Luben Social Network[Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention] Socially disconnection ‐ measured through the Loneliness Scale[Baseline ‐ pre intervention, 12 weeks, 26 weeks ‐ post commencement of intervention]
Epistemonikos ID: 798f05fa275d798dd4d5b6587f0dab6e6ea7cca8
First added on: Feb 20, 2024