Hearing Impairment, Cognitive Therapy and Coping

Phase 1

• Conditions: Hearing Loss; Tinnitus; Stress, Psychological; Mental Fatigue
• Interventions: Behavioral: 8-session CBTcourse; Behavioral: 8 session cognitive behavioral therapy

• Registration Number: NCT01206829
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Study Start: 2010-10
• Primary Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-14
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audiological rehabilitation	8 session cognitive behavioral therapy	16 hours of psychosocial rehabilitation course
Audiological rehabilitation	8-session CBTcourse	16 hours of psychosocial rehabilitation course

Primary Outcome Measures

Name	Time	Method
Work Ability Index	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	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	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)	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.

Trial Locations

Locations (1)

The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital; 🇳🇴 Oslo, Norway