An interventional study of Cognitive behavioural therapy in Hyperacusis, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-05-28.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Hyperacusis; 9 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 22 interventional studies indexed under Hyperacusis.
Browse Hyperacusis studies →Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Patients receiving 6 sessions of CBT conducted by a licensed psychologist. Sessions include psychoeducation, exposure treatment, behavioral activation and applied relaxation.
Behavioral: Cognitive behavioural therapy
Patient waits for CBT treatment for 6 months.
6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
Heart rate and skin conductance measured in response to sounds, in level with LDL:s.
Time frame: Evaluation for participance (day one), before treatment for waiting list patients (up to
The record gives a start of Jun 2004, a primary completion of Dec 2010 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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