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临床试验/NCT01206829
NCT01206829Unknown1 期

Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
180
试验地点
2
主要终点
Work Ability Index

研究概览

简要总结

A randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a waiting list control group. Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately, while the control group that will be offered the same course 12 months later. Main outcome measures are assessments of mental distress and vocational coping. We will also assess the distress associated with tinnitus, which is a potential moderator variable.

详细描述

Although the relationship between hearing loss and mental distress is not linear, it is known that hearing impaired individuals have increased vulnerability for development of symptoms of distress and fatigue. It is assumed that distressed hearing impaired individuals will have a tendency to use maladaptive and passive coping strategies, such as social withdrawal or reluctance to make use of hearing aid devices. On the other side, it is well documented that hearing impaired employers who are open about their handicap and make others aware of their situation, i.e. take an active coping approach, have fewer symptoms of distress and have better vocational functioning. The level of knowledge is limited and mainly based on cross sectional studies, and the way people cope with hearing impairment has been measured indirectly by questionnaires focusing on communication problems. We plan to conduct a randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (CBT) course The CBT intervention will be compared to a waiting list control group. Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately, while the control group that will be offered the same course 12 months later. Main outcome measures are assessments of mental distress and vocational coping. We will also assess the distress associated with tinnitus, which is a potential moderator variable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants need to be within the age range of 18-70 years, contain some formal employment and be able to document a mean, bilateral hearing loss of at least 40 dB.
  • Eligible participants need to have a HAD score of 7 or beyond

排除标准

  • Individuals without a clear vocational status (for instance on permanent/temporarily sick leave) and a mean bilateral hearing loss beneath 40 dB.
  • Individuals with a HAD score beneath 8 are excluded.

结局指标

主要结局

Work Ability Index

时间窗: At recruitment, at time of course completement and at 6 months post-treatment

Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.

Current employment status

时间窗: At recruitment, at time of course completement and at 6 months post-treatment.

Participants are asked to desribe their current vocational situation in some more detail. In addition, one item from the General Health Questionnaire, GQH-20 (World Health Organization, 2007) is included here: "To what degree is your ability to perform your ordinary work reduced today?"

Hospital Anxiety and Depression Scale; HADS

时间窗: At recruitment, at time of course completement and at 6 months post-treatment.

HADS consists of 14 items covering symptoms of anxiety and depression. HADS is a standarized and validated self report measure of general, mental health.

Fear of Negative Evaluation (FNE)

时间窗: At recruitment, at time of course completement and at 6 months post-treatment.

FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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