Hearing LossINSPIRESNCT04680845
INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
A study testing Self-affirmation in people with Hearing Loss, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Self-affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,012 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- UK-based adults
- Aged 60+
Who cannot join
- Adults younger than 60 years
- Not UK-based
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Self-affirmation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-affirmationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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…______________________________________________________________________ Receives: Behavioral: Self-affirmation |
| Control | No intervention | Participants will be asked to complete a standard questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing loss public stigma
Self-report questionnaire comprising seven items on 7-point Likert-type scales where 1 = low stigma and 7 = high stigma
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (4)
Hearing health seeking behaviours
Self-report questionnaire comprising eighteen items on no-yes scales where 0 = "no" and 1 = "yes"
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Anxiety about ageing
Self-report questionnaire comprising three items on 7-point Likert-type scales where 1 = low anxiety and 7 = high anxiety
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start18 Jan 2021
- Primary completion18 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Armitage, University of Manchester
- Investigators
- Kevin Munro, PhD, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680845
- Sponsor's protocol ID
- 2020-10597-17109
- Acronym
- INSPIRES
- Status last verified
- May 2023
- First submitted
- 17 Dec 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset used during the current study are available from the research team on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRES Hearing Health Trial - INnovative Psychological Intervention to REduce Stigma in Hearing Health Trial
- ClinicalTrials.gov ID
- NCT04680845
- Acronym / sponsor ID
- INSPIRES / 2020-10597-17109
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,012 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-affirmation | Experimental | Behavioral: Self-affirmationParticipants 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…______________________________________________________________________ |
| Control | No intervention | –Participants will be asked to complete a standard questionnaire. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- UK-based adults
- Aged 60+
Key exclusion criteria (2 listed)
- Adults younger than 60 years
- Not UK-based
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-affirmationAccording 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). | Behavioural | Self-affirmation |
Primary outcome
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
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
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
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
4 secondary outcomes
Hearing health seeking behaviours
Time frame: 6 months
Spontaneous self-affirmation
Time frame: 6 months
Subjective well-being
Time frame: 6 months
Anxiety about ageing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: Yes. The dataset used during the current study are available from the research team on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Munro, PhD study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-affirmation in people with Hearing Loss, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing loss public stigma (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.