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

Hearing Loss Clinical Trial

— INSPIRES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680845
• Other study ID #: 2020-10597-17109
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3012
• Est. completion date: July 31, 2021
• Est. primary completion date: July 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• UK-based adults

• Aged 60+

Exclusion Criteria:

• Adults younger than 60 years

• Not UK-based

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Behavioral:
• Self-affirmation
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).

Locations

Country	Name	City	State
United Kingdom	YouGov	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of Covid-19	Self-report questionnaire comprising fifteen items on 4-point Likert-type scales where 1 = low impact and 4 = high impact	6 months
Primary	Hearing loss public stigma	Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma	6 months
Primary	Hearing aid public stigma	Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma	6 months
Primary	Hearing loss self-stigma	Self-report questionnaire comprising five items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma	6 months
Primary	Hearing aid self-stigma	Self-report questionnaire comprising nine items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma	6 months
Secondary	Hearing health seeking behaviours	Self-report questionnaire comprising eighteen items on no-yes scales where 0 = "no" and 1 = "yes"	6 months
Secondary	Spontaneous self-affirmation	Self-report questionnaire comprising two items on 4-point Likert-type scales where 1 = low spontaneous self-affirmation and 4 = high spontaneous self-affirmation	6 months
Secondary	Subjective well-being	Self-report questionnaire comprising four items on 11-point Likert-type scales where 0 = low subjective well-being and 10 = high subjective well-being	6 months
Secondary	Anxiety about ageing	Self-report questionnaire comprising three items on 7-point Likert-type scales where 1 = low anxiety and 7 = high anxiety	6 months