Clinical trial NCT01206829: Hearing Impairment, Cognitive Therapy and Coping
Official title: Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hearing Loss
Tinnitus
Stress, Psychological
Mental Fatigue
Keywords: Hearing Impaired Persons
Tinnitus
Life Change Events
Adaptation, Psychological
Rehabilitation, Vocational
Cognitive Therapy
Avoidance Learning
Escape Reaction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: National Centre for Hearing Impairment and Mental Health
First posted: 2010-09-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Work Ability Index
timeFrame: At recruitment, at time of course completement and at 6 months post-treatment
measure: Current employment status
timeFrame: At recruitment, at time of course completement and at 6 months post-treatment.
measure: Hospital Anxiety and Depression Scale; HADS
timeFrame: At recruitment, at time of course completement and at 6 months post-treatment.
measure: Fear of Negative Evaluation (FNE)
timeFrame: At recruitment, at time of course completement and at 6 months post-treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Egil W Martinsen, Prof. dr. med.
role: STUDY_CHAIR
affiliation: The Norwegian Centre for Hearing Impairment and Mental Health
name: Katharine C Williams, cand. psychol.
role: PRINCIPAL_INVESTIGATOR
References: