Hearing Impairment, Cognitive Therapy and Coping
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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 |
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. |
- 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 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Behavioral: 8-session CBTcourse
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 |
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| Norway | |
| The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital | |
| Oslo, Norway, 0424 | |
| Study Chair: | Egil W Martinsen, Prof. dr. med. | Oslo University Hospital |
| Principal Investigator: | Katharine C Peterson, cand. psychol. | The Norwegian Centre for Hearing Impairment and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Egil W. Martinsen professor dr. med., Head of the Department for Research and Development, The Norwegian Centre for Hearing Impairment and Mental Health |
| 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: | March 20, 2012 |
| 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:
|
Hearing Loss Deafness Fatigue Mental Fatigue Stress, Psychological Tinnitus Hearing Disorders |
Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013