Clinical trial NCT01321814: Cognitive Behavioral Therapy for Hyperacusis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperacusis
Keywords: Hyperacusis
Personality
Comorbidity
Treatment
Cognitive behavioral therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala University
name: Uppsala University Hospital
First posted: 2011-03-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Life Inventory (QOLI)
timeFrame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
measure: Khalfa Hyperacusis Questionnaire
timeFrame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
measure: Loudness discomfort threshold
timeFrame: 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:
measure: The Mini-International Neuropsychiatric Interview (M.I.N.I)
timeFrame: At evaluation for participance (day one)
measure: Swedish universities Scales of Personality (SSP)
timeFrame: At evaluation for participance (day one)
measure: Tampa scale of Kinesiophobia - for Hyperacusis
timeFrame: Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
measure: Startle-response
timeFrame: Evaluation for participance (day one), before treatment for waiting list patients (up to
Other outcomes:
Locations:
city: Uppsala
country: Sweden
Study officials:
affiliation: Uppsala University
name: Lisa Ekselius, Professor
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_CHAIR
affiliation: Uppsala University Hospital
name: Hans C Larsen, Reader
role: STUDY_CHAIR
affiliation: Uppsala University/ Uppsala University Hospital
name: Linda Jüris, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: