Hearing Impairment, Cognitive Therapy and Coping

June 13, 2013 updated by: Oslo University Hospital

Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At recruitment, at time of course completement and at 6 months post-treatment
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?"
At recruitment, at time of course completement and at 6 months post-treatment.
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.
At recruitment, at time of course completement and at 6 months post-treatment.
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.
At recruitment, at time of course completement and at 6 months post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South-Eastern Norway Regional Health Authority
National Centre for Hearing Impairment and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009/2156 (REK)
  • 52-2009 AUS (Other Identifier: Kompetansesenter for personvern og sikkerhet, OUS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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