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Clinical Trials/NCT01206829
NCT01206829
Unknown
Phase 1

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

Oslo University Hospital1 site in 1 country180 target enrollmentOctober 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Oslo University Hospital
Enrollment
180
Locations
1
Primary Endpoint
Work Ability Index
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Work Ability Index

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

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