Hearing Impairment, Cognitive Therapy and Coping

• ClinicalTrials.gov Identifier: NCT01206829
• Recruitment Status: Unknown
• First Posted: September 22, 2010
• Last Update Posted: June 14, 2013
• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority; National Centre for Hearing Impairment and Mental Health
• Information provided by (Responsible Party): Oslo University Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hearing Loss; Tinnitus; Stress, Psychological; Mental Fatigue	Behavioral: 8-session CBTcourse; Behavioral: 8 session cognitive behavioral therapy	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: October 2010
• Actual Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2013

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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?"
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01206829
• Other Study ID Numbers: 2009/2156 (REK); 52-2009 AUS ( Other Identifier: Kompetansesenter for personvern og sikkerhet, OUS )
• First Posted: September 22, 2010
• Last Update Posted: June 14, 2013
• Last Verified: June 2013

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; Tinnitus; Mental Fatigue; Stress, Psychological; Fatigue; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms