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Completed

NCT Number: NCT04680845

INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YouGov

London, Greater London, UB2 5AQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • UK-based adults
  • Aged 60+

Exclusion criteria

  • Adults younger than 60 years
  • Not UK-based

Treatment and study plan

Self-affirmation

Behavioral

According to self-affirmation theory (Steele, 1988), 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 (Steele, 1988).

Primary outcomes

  1. Hearing loss public stigma

    Time frame: 6 months

    Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma

  2. Hearing aid public stigma

    Time frame: 6 months

    Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma

  3. Hearing loss self-stigma

    Time frame: 6 months

    Self-report questionnaire comprising five items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma

  4. Hearing aid self-stigma

    Time frame: 6 months

    Self-report questionnaire comprising nine items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma

Secondary outcomes

  1. Hearing health seeking behaviours

    Time frame: 6 months

    Self-report questionnaire comprising eighteen items on no-yes scales where 0 = "no" and 1 = "yes"

  2. Spontaneous self-affirmation

    Time frame: 6 months

    Self-report questionnaire comprising two items on 4-point Likert-type scales where 1 = low spontaneous self-affirmation and 4 = high spontaneous self-affirmation

  3. Subjective well-being

    Time frame: 6 months

    Self-report questionnaire comprising four items on 11-point Likert-type scales where 0 = low subjective well-being and 10 = high subjective well-being

  4. Anxiety about ageing

    Time frame: 6 months

    Self-report questionnaire comprising three items on 7-point Likert-type scales where 1 = low anxiety and 7 = high anxiety

Other outcomes

  1. Impact of Covid-19

    Time frame: 6 months

    Self-report questionnaire comprising fifteen items on 4-point Likert-type scales where 1 = low impact and 4 = high impact

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Acronym: INSPIRES

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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