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Hearing Impairment, Cognitive Therapy and Coping

Primary Purpose

Hearing Loss, Tinnitus, Stress, Psychological

Status
Unknown status
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
8-session CBTcourse
8 session cognitive behavioral therapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Impaired Persons, Tinnitus, Life Change Events, Adaptation, Psychological, Rehabilitation, Vocational, Cognitive Therapy, Avoidance Learning, Escape Reaction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Audiological rehabilitation

Arm Description

16 hours of psychosocial rehabilitation course

Outcomes

Primary Outcome Measures

Work Ability Index
Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.
Current employment status
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
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)
FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2010
Last Updated
June 13, 2013
Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, National Centre for Hearing Impairment and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT01206829
Brief Title
Hearing Impairment, Cognitive Therapy and Coping
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, National Centre for Hearing Impairment and Mental Health

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Tinnitus, Stress, Psychological, Mental Fatigue
Keywords
Hearing Impaired Persons, Tinnitus, Life Change Events, Adaptation, Psychological, Rehabilitation, Vocational, Cognitive Therapy, Avoidance Learning, Escape Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audiological rehabilitation
Arm Type
Active Comparator
Arm Description
16 hours of psychosocial rehabilitation course
Intervention Type
Behavioral
Intervention Name(s)
8-session CBTcourse
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
8 session cognitive behavioral therapy
Intervention Description
8 sessions cognitive behavioral therapy in group
Primary Outcome Measure Information:
Title
Work Ability Index
Description
Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.
Time Frame
At recruitment, at time of course completement and at 6 months post-treatment
Title
Current employment status
Description
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?"
Time Frame
At recruitment, at time of course completement and at 6 months post-treatment.
Title
Hospital Anxiety and Depression Scale; HADS
Description
HADS consists of 14 items covering symptoms of anxiety and depression. HADS is a standarized and validated self report measure of general, mental health.
Time Frame
At recruitment, at time of course completement and at 6 months post-treatment.
Title
Fear of Negative Evaluation (FNE)
Description
FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.
Time Frame
At recruitment, at time of course completement and at 6 months post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egil W Martinsen, Prof. dr. med.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katharine C Williams, cand. psychol.
Organizational Affiliation
The Norwegian Centre for Hearing Impairment and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

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Hearing Impairment, Cognitive Therapy and Coping

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