Cognitive Behavioral Therapy for Hyperacusis
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|ClinicalTrials.gov Identifier: NCT01321814|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : May 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperacusis||Behavioral: Cognitive behavioural therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2012|
Experimental: Cognitive behavioural therapy (CBT)
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
6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
No Intervention: Waiting list
Patient waits for CBT treatment for 6 months.
- 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.
- The Mini-International Neuropsychiatric Interview (M.I.N.I) [ Time Frame: At evaluation for participance (day one) ]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.
- Swedish universities Scales of Personality (SSP) [ Time Frame: At evaluation for participance (day one) ]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.
- 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 ]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.
- Startle-response [ Time Frame: Evaluation for participance (day one), before treatment for waiting list patients (up to ]Heart rate and skin conductance measured in response to sounds, in level with LDL:s.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321814
|Uppsala, Sweden, 75185|
|Study Director:||Lisa Ekselius, Professor||Uppsala University|
|Study Chair:||Gerhard Andersson, Professor||Linkoeping University|
|Study Chair:||Hans C Larsen, Reader||Uppsala University Hospital|
|Principal Investigator:||Linda Jüris, PhD Student||Uppsala University/ Uppsala University Hospital|