Hearing LossPhase 1NCT01206829
Hearing Impairment, Cognitive Therapy and Coping
A Phase 1 study testing 8-session CBTcourse and 8 session cognitive behavioral therapy in people with Hearing Loss and Tinnitus, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss, Tinnitus, Stress, Psychological
- What is being tested?
- 8-session CBTcourse and 8 session cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital
Oslo, Norway, 0424
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Tinnitus, Stress, Psychological, Mental Fatigue
- Being tested
- 8-session CBTcourse, 8 session cognitive behavioral therapy
- Keywords
- Hearing Impaired Persons, Tinnitus, Life Change Events, Adaptation, Psychological, Rehabilitation, Vocational, Cognitive Therapy, Avoidance Learning, Escape Reaction
- Medical subject headings
- Hearing Loss, Tinnitus, Stress, Psychological, Mental Fatigue, Escape Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-session CBTcourseBehavioural
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.
8 session cognitive behavioral therapyBehavioural
8 sessions cognitive behavioral therapy in group
| Study group | Role | What they receive |
|---|---|---|
| Audiological rehabilitation | Active comparator | 16 hours of psychosocial rehabilitation course Receives: Behavioral: 8-session CBTcourse; Behavioral: 8 session cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Ability Index
Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.
Measured: At recruitment, at time of course completement and at 6 months post-treatment
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?"
Measured: At recruitment, at time of course completement and at 6 months post-treatment.
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.
Measured: At recruitment, at time of course completement and at 6 months post-treatment.
Fear of Negative Evaluation (FNE)
FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.
Measured: At recruitment, at time of course completement and at 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, National Centre for Hearing Impairment and Mental Health
- Responsible party
- Sponsor
- Investigators
- Egil W Martinsen, Prof. dr. med., Study chair, Oslo University HospitalKatharine C Williams, cand. psychol., Principal investigator, The Norwegian Centre for Hearing Impairment and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206829
- Sponsor's protocol ID
- 2009/2156 (REK)
- Other IDs
- 52-2009 AUS
- Status last verified
- Jun 2013
- First submitted
- 21 Sep 2010
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.
- ClinicalTrials.gov ID
- NCT01206829
- Acronym / sponsor ID
- 2009/2156 (REK)
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, National Centre for Hearing Impairment and Mental Health
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Audiological rehabilitation | Active comparator | Behavioral: 8-session CBTcourse, Behavioral: 8 session cognitive behavioral therapy16 hours of psychosocial rehabilitation course |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-session CBTcourseHearing 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. | Behavioural | Audiological rehabilitation |
| 8 session cognitive behavioral therapy8 sessions cognitive behavioral therapy in group | Behavioural | Audiological rehabilitation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egil W Martinsen, Prof. dr. med. study chair
Oslo University Hospital
Katharine C Williams, cand. psychol. principal investigator
The Norwegian Centre for Hearing Impairment and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 8-session CBTcourse and 8 session cognitive behavioral therapy in people with Hearing Loss and Tinnitus, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Ability Index (time frame: At recruitment, at time of course completement and at 6 months post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.