Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000406606
Ethics application status
Approved
Date submitted
13/03/2023
Date registered
21/04/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
21/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The hearables study - addressing mental health in hearing impaired older adults through the use of hearable devices and behavioural activation (BA) therapy.
Scientific title
Impact of Hearables & BA on Mental Distress and Social Isolation in Hearing Impaired Older Adults
Secondary ID [1] 309166 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 329301 0
Social isolation 329302 0
Hearing loss 329303 0
Poor quality of life 329523 0
Condition category
Condition code
Mental Health 326246 326246 0 0
Depression
Mental Health 326247 326247 0 0
Other mental health disorders
Ear 326248 326248 0 0
Other ear disorders
Mental Health 326461 326461 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325644 0
Prevention
Intervention code [2] 325645 0
Treatment: Devices
Comparator / control treatment
The Control group will not be exposed to BA or HA which will allow us to measure the significance of both these interventions if this reduces symptoms of loneliness and depression.
Control group
Active

Outcomes
Primary outcome [1] 334152 0
Changes in mood assessed through the Patient Health Questionnaire - 9 (PHQ-9)
Timepoint [1] 334152 0
Baseline - pre intervention, 12 weeks - primary time point, 26 weeks - post commencement of intervention.
Primary outcome [2] 334431 0
Hearing loss - assessed through Hearing Handicap Inventory for Elderly and Kuduwave hearing assessment.
Timepoint [2] 334431 0
Baseline - pre intervention, 12 weeks - primary time point, 26 weeks - post commencement of intervention
Secondary outcome [1] 419512 0
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.
Timepoint [1] 419512 0
Baseline - pre intervention, 12 weeks , 26 weeks - post commencement of intervention
Secondary outcome [2] 420956 0
Anxiety - measured through the General Anxiety Index
Timepoint [2] 420956 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention
Secondary outcome [3] 420957 0
Social Isolation - measured through the Luben Social Network
Timepoint [3] 420957 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention
Secondary outcome [4] 420958 0
Socially disconnection - measured through the Loneliness Scale
Timepoint [4] 420958 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention
Secondary outcome [5] 420959 0
Comorbidity - measuring physical comorbidities through FCI
Timepoint [5] 420959 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention
Secondary outcome [6] 420960 0
Quality of life and independence - measured through Instrumental Activities of Daily Living (IADL)
Timepoint [6] 420960 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention
Secondary outcome [7] 420961 0
Frailty measured through the Fried Frailty Assessment
Timepoint [7] 420961 0
Baseline - pre intervention, 12 weeks, 26 weeks - post commencement of intervention

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have hearing loss of a severity to warrant fitting of hearing aids or cochlear implantation
Have poorer ear thresholds above 65 dB between 500 Hz to 4 kHz
Have asymmetrical Hearing Loss (HL)
Decline to consider use of HA
Have significant cognitive impairment as demonstrated by a Montreal Cognitive assessment for the Hearing Impaired (HI-MOCA) score equal to and greater than 18
Have visual impairment that limits their ability to read Times New Roman font size 16 (a requirement for two sentences of HI-MOCA)
Have a severe medical or psychiatric illness that limits the ability of the participant to attend appointments or sustain participation in the study
Have active suicidal ideation (Assessed through PHQ-9 and clinicians on study team)
Are unable or unwilling to provide written, informed consent to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in permuted blocks of 6, 8 and 10 will occur to ensure equal allocation to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Standard descriptive statistics, Linear mixed effect models, Mixed effects logistics regression (Xtlogit)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2023
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24283 0
Lions Hearing Clinic - Nedlands - Nedlands
Recruitment postcode(s) [1] 39825 0
6000 - Perth
Recruitment postcode(s) [2] 39826 0
6009 - Crawley
Recruitment postcode(s) [3] 39827 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 313365 0
Government body
Name [1] 313365 0
National Health & Medical Research Council
Country [1] 313365 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
UWA - WA Centre for Health & Ageing
6th Floor
Medical Research Foundation Building
50 Murray Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 315122 0
Other
Name [1] 315122 0
Ear Science Institute Australia
Address [1] 315122 0
Sarich Building
3rd Floor
Ear Science Institute Australia
8 Verdun St, Nedlands WA 6009
Country [1] 315122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312584 0
University of Western Australia HREC
Ethics committee address [1] 312584 0
HREC Research Services
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 312584 0
Australia
Date submitted for ethics approval [1] 312584 0
09/03/2023
Approval date [1] 312584 0
23/05/2023
Ethics approval number [1] 312584 0
2022/ET000715

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125182 0
Dr Dona Jaykody
Address 125182 0
Sarich Research Building
Ear Science Institute Australia
3rd Floor
8 Verdun St, Nedlands WA 6009
Country 125182 0
Australia
Phone 125182 0
+61 0410 080 007
Fax 125182 0
Email 125182 0
Dona.Jaykody@earscience.org.au
Contact person for public queries
Name 125183 0
Mrs Hema Patel
Address 125183 0
Sarich Research Building
Ear Science Institute Australia
3rd Floor
8 Verdun St, Nedlands WA 6009
Country 125183 0
Australia
Phone 125183 0
+61 8 6457 0548
Fax 125183 0
Email 125183 0
hema.patel@uwa.edu.au
Contact person for scientific queries
Name 125184 0
Dr Dona Jaykody
Address 125184 0
Sarich Research Building
Ear Science Institute Australia
3rd Floor
8 Verdun St, Nedlands WA 6009
Country 125184 0
Australia
Phone 125184 0
+61 8 6457 0548
Fax 125184 0
Email 125184 0
Dona.Jaykody@earscience.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.