Hearing Impairment, Cognitive Therapy and Coping

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01206829
• Other study ID #: 2009/2156 (REK)
• Secondary ID: 52-2009 AUS
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 21, 2010
• Last updated: June 13, 2013
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Mental Fatigue
• Stress, Psychological
• Tinnitus

Intervention

Behavioral:
• 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.
• 8 session cognitive behavioral therapy
8 sessions cognitive behavioral therapy in group

Locations

Country	Name	City	State
Norway	The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	National Centre for Hearing Impairment and Mental Health, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	No
Primary	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.	No
Primary	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.	No

External Links

•   Official website of project organization (Oslo University Hospital)