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Clinical Trials/NCT01321814
NCT01321814
Completed
Not Applicable

Cognitive Behavioral Therapy for Hyperacusis

Linkoeping University0 sites62 target enrollmentJune 2004
ConditionsHyperacusis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperacusis
Sponsor
Linkoeping University
Enrollment
62
Primary Endpoint
Khalfa Hyperacusis Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
December 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Andersson

Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Scoring "moderate" or "high" on suicidality, according to M.I.N.I
  • Moderate to severe depression
  • Psychotic disorders

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • The Mini-International Neuropsychiatric Interview (M.I.N.I)(At evaluation for participance (day one))
  • Swedish universities Scales of Personality (SSP)(At evaluation for participance (day one))
  • Tampa scale of Kinesiophobia - for Hyperacusis(Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment)
  • Startle-response(Evaluation for participance (day one), before treatment for waiting list patients (up to)

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