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Hearing Impairment, Cognitive Therapy and Coping

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206829
First Posted: September 22, 2010
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
South-Eastern Norway Regional Health Authority
National Centre for Hearing Impairment and Mental Health
Information provided by (Responsible Party):
Oslo University Hospital
September 21, 2010
September 22, 2010
June 14, 2013
October 2010
December 2012   (Final data collection date for primary outcome measure)
  • Work Ability Index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01206829 on ClinicalTrials.gov Archive Site
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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.
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hearing Loss
  • Tinnitus
  • Stress, Psychological
  • Mental Fatigue
  • 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.
  • Behavioral: 8 session cognitive behavioral therapy
    8 sessions cognitive behavioral therapy in group
Active Comparator: Audiological rehabilitation
16 hours of psychosocial rehabilitation course
Interventions:
  • Behavioral: 8-session CBTcourse
  • Behavioral: 8 session cognitive behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
180
December 2013
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01206829
2009/2156 (REK)
52-2009 AUS ( Other Identifier: Kompetansesenter for personvern og sikkerhet, OUS )
No
Not Provided
Not Provided
Oslo University Hospital
Oslo University Hospital
  • South-Eastern Norway Regional Health Authority
  • National Centre for Hearing Impairment and Mental Health
Study Chair: Egil W Martinsen, Prof. dr. med. Oslo University Hospital
Principal Investigator: Katharine C Williams, cand. psychol. The Norwegian Centre for Hearing Impairment and Mental Health
Oslo University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP