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

NCT04680845 | Completed

• 1 other identifier: 2020-10597-17109
• Study Type: interventional
• Target: 3,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Hearing health seeking behaviours

  6 months

• Spontaneous self-affirmation

  6 months

• Subjective well-being

  6 months

• Anxiety about ageing

  6 months

Other Outcomes (1)

• Impact of Covid-19

  6 months

Study Arms (2)

Self-affirmation

EXPERIMENTAL

Participants will be asked to complete a standard questionnaire including: The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you. If I feel threatened or anxious, then I will… …think about the things I value about myself * remember things that I have succeeded in * think about what I stand for * think about things that are important to me If…\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Behavioral: Self-affirmation

Control

NO INTERVENTION

Participants will be asked to complete a standard questionnaire.

Interventions

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).

Self-affirmation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UK-based adults
• Aged 60+

You may not qualify if:

• Adults younger than 60 years
• Not UK-based

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

YouGov

London, Greater London, UB2 5AQ, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Munro, PhD

  University of Manchester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Psychology

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: January 18, 2021
• Primary Completion: July 18, 2021
• Study Completion: July 31, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Following publication of the main paper for 5 years.
• Access Criteria: On reasonable request.

Locations

GB (1)