Hearing Impairment, Cognitive Therapy and Coping

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-12-31

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.

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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.

Conditions

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Hearing Loss Tinnitus Stress, Psychological Mental Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Audiological rehabilitation

16 hours of psychosocial rehabilitation course

Group Type ACTIVE_COMPARATOR

8-session CBTcourse

Intervention Type BEHAVIORAL

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.

8 session cognitive behavioral therapy

Intervention Type BEHAVIORAL

8 sessions cognitive behavioral therapy in group

Interventions

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8-session CBTcourse

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.

Intervention Type BEHAVIORAL

8 session cognitive behavioral therapy

8 sessions cognitive behavioral therapy in group

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No