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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-affirmation
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • UK-based adults
  • Aged 60+

Exclusion Criteria:

  • Adults younger than 60 years
  • Not UK-based

Sites / Locations

  • YouGov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-affirmation

Control

Arm Description

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…______________________________________________________________________

Participants will be asked to complete a standard questionnaire.

Outcomes

Primary Outcome Measures

Hearing loss public stigma
Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Hearing aid public stigma
Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Hearing loss self-stigma
Self-report questionnaire comprising five items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Hearing aid self-stigma
Self-report questionnaire comprising nine items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma

Secondary Outcome Measures

Hearing health seeking behaviours
Self-report questionnaire comprising eighteen items on no-yes scales where 0 = "no" and 1 = "yes"
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
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
Anxiety about ageing
Self-report questionnaire comprising three items on 7-point Likert-type scales where 1 = low anxiety and 7 = high anxiety

Full Information

First Posted
December 17, 2020
Last Updated
May 16, 2023
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT04680845
Brief Title
INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
Acronym
INSPIRES
Official Title
INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
July 18, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-affirmation
Arm Type
Experimental
Arm Description
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…______________________________________________________________________
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be asked to complete a standard questionnaire.
Intervention Type
Behavioral
Intervention Name(s)
Self-affirmation
Intervention Description
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 Outcome Measure Information:
Title
Hearing loss public stigma
Description
Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Time Frame
6 months
Title
Hearing aid public stigma
Description
Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Time Frame
6 months
Title
Hearing loss self-stigma
Description
Self-report questionnaire comprising five items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Time Frame
6 months
Title
Hearing aid self-stigma
Description
Self-report questionnaire comprising nine items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hearing health seeking behaviours
Description
Self-report questionnaire comprising eighteen items on no-yes scales where 0 = "no" and 1 = "yes"
Time Frame
6 months
Title
Spontaneous self-affirmation
Description
Self-report questionnaire comprising two items on 4-point Likert-type scales where 1 = low spontaneous self-affirmation and 4 = high spontaneous self-affirmation
Time Frame
6 months
Title
Subjective well-being
Description
Self-report questionnaire comprising four items on 11-point Likert-type scales where 0 = low subjective well-being and 10 = high subjective well-being
Time Frame
6 months
Title
Anxiety about ageing
Description
Self-report questionnaire comprising three items on 7-point Likert-type scales where 1 = low anxiety and 7 = high anxiety
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Impact of Covid-19
Description
Self-report questionnaire comprising fifteen items on 4-point Likert-type scales where 1 = low impact and 4 = high impact
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: UK-based adults Aged 60+ Exclusion Criteria: Adults younger than 60 years Not UK-based
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Munro, PhD
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
YouGov
City
London
State/Province
Greater London
ZIP/Postal Code
UB2 5AQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset used during the current study are available from the research team on reasonable request.
IPD Sharing Time Frame
Following publication of the main paper for 5 years.
IPD Sharing Access Criteria
On reasonable request.

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

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