Hearing Impairment, Cognitive Therapy and Coping

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hearing Loss, Tinnitus, Stress, Psychological, Mental Fatigue

Intervention / Treatment
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* Behavioral: 8-session CBTcourse
* Behavioral: 8 session cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Audiological rehabilitation<br>16 hours of psychosocial rehabilitation course | Behavioral: 8-session CBTcourse<br>* Hearing impaired workers voluntarily sign up for an 8 session cognitive therapy course. The study has a waiting list control group design. Participants will be randomized assigned to either an experiment group that will be offered to start on an immediate course, or a control group that will be offered the same course 12 months later.<br>Behavioral: 8 session cognitive behavioral therapy<br>* 8 sessions cognitive behavioral therapy in group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Ability Index | Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning. | At recruitment, at time of course completement and at 6 months post-treatment | 
| Current employment status | 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? | At recruitment, at time of course completement and at 6 months post-treatment. | 
| Hospital Anxiety and Depression Scale; HADS | HADS consists of 14 items covering symptoms of anxiety and depression. HADS is a standarized and validated self report measure of general, mental health. | At recruitment, at time of course completement and at 6 months post-treatment. | 
| Fear of Negative Evaluation (FNE) | FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome. | At recruitment, at time of course completement and at 6 months post-treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Impaired Persons, Tinnitus, Life Change Events, Adaptation, Psychological, Rehabilitation, Vocational, Cognitive Therapy, Avoidance Learning, Escape Reaction