Hearing Impairment, Cognitive Therapy and Coping
|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|
|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.
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|