HyperacusisNCT01321814
Cognitive Behavioral Therapy for Hyperacusis
A study testing Cognitive behavioural therapy in people with Hyperacusis, run by Linkoeping University at 1 site in Sweden.
Trial summary
The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT) can be useful for people suffering from Hyperacusis. Also, the investigators are interested in investigating this group of patients on psychiatric and somatic comorbidity, personality traits, and startle response to sounds. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperacusis
- What is being tested?
- Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2004to Dec 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient understands and can speak Swedish well
- Hyperacusis is the primary audiological problem
- Loudness discomfort thresholds below 90 dB
- Hearing levels better than 40dB on the best ear
- Resident of Uppsala, Stockholm or Vastmanland
- Possibility to travel to Uppsala or Vasteras for examination and treatment
Who cannot join
- Scoring "moderate" or "high" on suicidality, according to M.I.N.I
- Moderate to severe depression
- Psychotic disorders
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT) can be useful for people suffering from Hyperacusis.
Also, the investigators are interested in investigating this group of patients on psychiatric and somatic comorbidity, personality traits, and startle response to sounds.
The investigators will also study the audiological measures commonly used in Sweden to measure hyperacusis, and investigate their validity.
The investigators hypothesize that CBT might be helpful for patients suffering from Hyperacusis.
Read the detailed description
Hyperacusis, defined as unusual intolerance to ordinary environmental sounds, is a common problem for which there are no controlled trials on psychological treatment. Given the avoidance strategies present in hyperacusis, and similarities with problems such as tinnitus and chronic pain, cognitive behaviour therapy (CBT) is hypothesized to be helpful for patients with hyperacusis. In this randomized controlled study of 60 patients with hyperacusis, CBT was compared with a waiting list control group using the Loudness Discomfort Level test (LDL), the Hyperacusis Questionnaire, the Hospital Anxiety and Depression Scales, the Quality of Life Inventory and an adapted version of the Tampa Scale of Kinesiophobia. There were significant between-group effects in favour of the CBT group on all measures except for the HADS anxiety scale. Between-group effect sizes were moderate to high, with Cohen's d = 0.67 and 0.69 per ear, respectively, for the primary measure LDL, and ranging from d = 0.32 to 1.36 for the secondary measures. The differences between groups ceased to exist when the waiting list group was treated later with CBT, and the treatment results were largely maintained after 12 months. In conclusion, CBT is a promising treatment for hyperacusis, although more research is necessary.
- Conditions
- Hyperacusis
- Being tested
- Cognitive behavioural therapy
- Keywords
- Hyperacusis, Personality, Comorbidity, Treatment, Cognitive behavioral therapy
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy (CBT) | Experimental | Patients receiving 6 sessions of CBT conducted by a licensed psychologist. Sessions include psychoeducation, exposure treatment, behavioral activation and applied relaxation. Receives: Behavioral: Cognitive behavioural therapy |
| Waiting list | No intervention | Patient waits for CBT treatment for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Inventory (QOLI)
Inventory measuring how patients' percieve the importance of and their satisfaction with many variables that concludes life quality, for instance economy, physical health and family life.
Measured: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Khalfa Hyperacusis Questionnaire
A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.
Measured: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Loudness discomfort threshold
Audiological measure where the patient is exposed to sounds, gradually of higher volume. The patient is instructed to indicate when the sound level is uncomfortably loud, and that terminates the exposure. The test is performed by an audiologist using a calibrated audiometer.
Measured: Time Frame: (FDAAA) Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Secondary outcomes (4)
The Mini-International Neuropsychiatric Interview (M.I.N.I)
M.I.N.I is a short structured diagnostic interview (Sheehan et al, 1998), developed to detect DSM-IV and ICD-10 psychiatric disorders and was performed to investigate psychiatric comorbidity in this study. The Swedish version, 5.0.0. was used.
Measured: At evaluation for participance (day one)
Swedish universities Scales of Personality (SSP)
SSP aims to measure personality correlates as well as biological correlates of some psychiatric disorders in order to define vulnerability factors (Gustavsson et al, 2000). The test consists of 13 scales, for instance somatic trait anxiety, psychic trait anxiety and stress susceptibility.
Measured: At evaluation for participance (day one)
Tampa scale of Kinesiophobia - for Hyperacusis
TSK is a questionnaire used to measure fear of movement or reinjury in chronic pain patients. For this study, we adapted TSK for Hyperacusis patients.
Measured: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Startle-response
Heart rate and skin conductance measured in response to sounds, in level with LDL:s.
Measured: Evaluation for participance (day one), before treatment for waiting list patients (up to
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJun 2004
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperacusisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Uppsala University Hospital
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Lisa Ekselius, Professor, Study director, Uppsala UniversityGerhard Andersson, Professor, Study chair, Linkoeping UniversityHans C Larsen, Reader, Study chair, Uppsala University HospitalLinda Jüris, PhD Student, Principal investigator, Uppsala University/ Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321814
- Sponsor's protocol ID
- GA-LJ-HYP1
- Status last verified
- May 2014
- First submitted
- 23 Mar 2011
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Hyperacusis
- ClinicalTrials.gov ID
- NCT01321814
- Acronym / sponsor ID
- GA-LJ-HYP1
- Conditions
- Hyperacusis
- Keywords
- Hyperacusis, Personality, Comorbidity, Treatment, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Uppsala University, Uppsala University Hospital
- Study start
- Jun 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Mar 2011 (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.
The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT) can be useful for people suffering from Hyperacusis.
Also, the investigators are interested in investigating this group of patients on psychiatric and somatic comorbidity, personality traits, and startle response to sounds.
The investigators will also study the audiological measures commonly used in Sweden to measure hyperacusis, and investigate their validity.
The investigators hypothesize that CBT might be helpful for patients suffering from Hyperacusis.
Detailed description
Hyperacusis, defined as unusual intolerance to ordinary environmental sounds, is a common problem for which there are no controlled trials on psychological treatment. Given the avoidance strategies present in hyperacusis, and similarities with problems such as tinnitus and chronic pain, cognitive behaviour therapy (CBT) is hypothesized to be helpful for patients with hyperacusis. In this randomized controlled study of 60 patients with hyperacusis, CBT was compared with a waiting list control group using the Loudness Discomfort Level test (LDL), the Hyperacusis Questionnaire, the Hospital Anxiety and Depression Scales, the Quality of Life Inventory and an adapted version of the Tampa Scale of Kinesiophobia. There were significant between-group effects in favour of the CBT group on all measures except for the HADS anxiety scale. Between-group effect sizes were moderate to high, with Cohen's d = 0.67 and 0.69 per ear, respectively, for the primary measure LDL, and ranging from d = 0.32 to 1.36 for the secondary measures. The differences between groups ceased to exist when the waiting list group was treated later with CBT, and the treatment results were largely maintained after 12 months. In conclusion, CBT is a promising treatment for hyperacusis, although more research is necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy (CBT) | Experimental | Behavioral: Cognitive behavioural therapyPatients receiving 6 sessions of CBT conducted by a licensed psychologist. Sessions include psychoeducation, exposure treatment, behavioral activation and applied relaxation. |
| Waiting list | No intervention | –Patient waits for CBT treatment for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient understands and can speak Swedish well
- Hyperacusis is the primary audiological problem
- Loudness discomfort thresholds below 90 dB
- Hearing levels better than 40dB on the best ear
- Resident of Uppsala, Stockholm or Vastmanland
Key exclusion criteria (3 listed)
- Scoring "moderate" or "high" on suicidality, according to M.I.N.I
- Moderate to severe depression
- Psychotic disorders
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 |
|---|---|---|
| Cognitive behavioural therapy6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation. | Behavioural | Cognitive behavioural therapy (CBT) |
Primary outcome
Quality of Life Inventory (QOLI)
Time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Inventory measuring how patients' percieve the importance of and their satisfaction with many variables that concludes life quality, for instance economy, physical health and family life.
Khalfa Hyperacusis Questionnaire
Time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.
Loudness discomfort threshold
Time frame: Time Frame: (FDAAA) Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Audiological measure where the patient is exposed to sounds, gradually of higher volume. The patient is instructed to indicate when the sound level is uncomfortably loud, and that terminates the exposure. The test is performed by an audiologist using a calibrated audiometer.
4 secondary outcomes
The Mini-International Neuropsychiatric Interview (M.I.N.I)
Time frame: At evaluation for participance (day one)
Swedish universities Scales of Personality (SSP)
Time frame: At evaluation for participance (day one)
Tampa scale of Kinesiophobia - for Hyperacusis
Time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Startle-response
Time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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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.
Lisa Ekselius, Professor study director
Uppsala University
Gerhard Andersson, Professor study chair
Linkoeping University
Hans C Larsen, Reader study chair
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy in people with Hyperacusis, run by Linkoeping University at 1 site in Sweden.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2014. 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 Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life Inventory (QOLI) (time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment). The study lists 3 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 28 May 2014.