Clinical trial NCT04680845: INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
Official title: INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 3012
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Reminding people they are moral adaptable human beings ("self-affirming") reduces the perceived stigma associated with wearing hearing aids and increases actual hearing aid use. The proposed study aims to reduce stigma in a representative sample of people aged over 60 from the general population who may or may not already be wearing hearing aids and improve multiple hearing health outcomes (e.g., attending screening, device use).

Methods/Design: Double-blinded randomized controlled trial in which a representative sample of people aged over 60 from the general population will be asked to complete surveys about hearing stigma, hearing loss and multiple hearing health outcomes. Participants randomized to the control group will only complete the survey; participants in the intervention group will be asked to affirm their values. Six months later, all participants will complete the same survey to assess outcomes.

Discussion: The proposed research will lead to a brief psychological intervention to reduce stigma in relation to hearing loss/aids.

Detailed description: According to self-affirmation theory, defensiveness arises because people are motivated to defend their global sense of self-worth, which in the present case is threatened by perceptions of hearing aids/loss. However, if a person's self-image can be bolstered (affirmed) in a domain that is important to them, thereby preserving self-integrity, the individual should be less likely to process the threatening (i.e., stigmatizing in the present context) information defensively. Accumulated empirical evidence demonstrates that affirming the self: (a) reduces public stigma, (b) reduces self-stigma, and (c) causes meaningful changes in behaviour. Following a pilot-feasibility trial showing that self-affirming caused significant reductions in first-time hearing aid users' anxieties about ageing and increased their hearing aid use by almost 2 hours/day.

Eligibility criteria: Inclusion Criteria:

* UK-based adults
* Aged 60+

Exclusion Criteria:

* Adults younger than 60 years
* Not UK-based

Primary outcomes:
measure: Hearing loss public stigma
timeFrame: 6 months
measure: Hearing aid public stigma
timeFrame: 6 months
measure: Hearing loss self-stigma
timeFrame: 6 months
measure: Hearing aid self-stigma
timeFrame: 6 months
Secondary outcomes:
measure: Hearing health seeking behaviours
timeFrame: 6 months
measure: Spontaneous self-affirmation
timeFrame: 6 months
measure: Subjective well-being
timeFrame: 6 months
measure: Anxiety about ageing
timeFrame: 6 months
Other outcomes:
measure: Impact of Covid-19
timeFrame: 6 months
Locations:
city: London
country: United Kingdom
facility: YouGov
state: Greater London
Study officials:
affiliation: University of Manchester
name: Kevin Munro, PhD
role: STUDY_CHAIR
References: