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Hearing Impairment, Cognitive Therapy and Coping

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01206829
Enrollment
180
Registered
2010-09-22
Start date
2010-10-31
Completion date
2013-12-31
Last updated
2013-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Mental Fatigue, Stress, Psychological, Tinnitus

Keywords

Hearing Impaired Persons, Tinnitus, Life Change Events, Adaptation, Psychological, Rehabilitation, Vocational, Cognitive Therapy, Avoidance Learning, Escape Reaction

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.

Interventions

BEHAVIORAL8-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.

BEHAVIORAL8 session cognitive behavioral therapy

8 sessions cognitive behavioral therapy in group

Sponsors

South-Eastern Norway Regional Health Authority
CollaboratorOTHER
National Centre for Hearing Impairment and Mental Health
CollaboratorUNKNOWN
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Work Ability IndexAt recruitment, at time of course completement and at 6 months post-treatmentWork Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.
Current employment statusAt 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; HADSAt 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026