Hearing Impairment, Cognitive Therapy and Coping

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
National Centre for Hearing Impairment and Mental Health
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01206829
First received: September 21, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hearing Loss
Tinnitus
Stress, Psychological
Mental Fatigue
Behavioral: 8-session CBTcourse
Behavioral: 8 session cognitive behavioral therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Work Ability Index [ Time Frame: At recruitment, at time of course completement and at 6 months post-treatment ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.


Estimated Enrollment: 180
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Audiological rehabilitation
16 hours of psychosocial rehabilitation course
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206829

Locations
Norway
The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
National Centre for Hearing Impairment and Mental Health
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01206829     History of Changes
Other Study ID Numbers: 2009/2156 (REK), 52-2009 AUS
Study First Received: September 21, 2010
Last Updated: June 13, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Hearing Impaired Persons
Tinnitus
Life Change Events
Adaptation, Psychological
Rehabilitation, Vocational
Cognitive Therapy
Avoidance Learning
Escape Reaction

Additional relevant MeSH terms:
Deafness
Hearing Loss
Mental Fatigue
Stress, Psychological
Tinnitus
Behavioral Symptoms
Ear Diseases
Fatigue
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014