Hearing Impairment, Cognitive Therapy and Coping
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|ClinicalTrials.gov Identifier: NCT01206829|
Recruitment Status : Unknown
Verified June 2013 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 22, 2010
Last Update Posted : June 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss Tinnitus Stress, Psychological Mental Fatigue||Behavioral: 8-session CBTcourse Behavioral: 8 session cognitive behavioral therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2010|
|Actual Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206829
|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 Williams, cand. psychol.||The Norwegian Centre for Hearing Impairment and Mental Health|