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临床试验/NCT04680845
NCT04680845已完成不适用

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

University of Manchester2 个研究点 分布在 1 个国家目标入组 3,012 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,012
试验地点
2
主要终点
Hearing loss public stigma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • UK-based adults

排除标准

  • Adults younger than 60 years
  • Not UK-based

结局指标

主要结局

Hearing loss public stigma

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 6 months

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

次要结局

  • Hearing health seeking behaviours(6 months)
  • Spontaneous self-affirmation(6 months)
  • Subjective well-being(6 months)
  • Anxiety about ageing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Armitage

Professor of Health Psychology

University of Manchester

研究点 (2)

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