Cognitive Behavioral Therapy for Hyperacusis

Hyperacusis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321814
• Other study ID #: GA-LJ-HYP1
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: May 24, 2014
• Start date: June 2004
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperacusis

Intervention

Behavioral:
• Cognitive behavioural therapy
6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Uppsala University, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment	No
Primary	Khalfa Hyperacusis Questionnaire	A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.	Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment	No
Primary	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: (FDAAA) Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment	No
Secondary	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.	At evaluation for participance (day one)	No
Secondary	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.	At evaluation for participance (day one)	No
Secondary	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.	Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment	No
Secondary	Startle-response	Heart rate and skin conductance measured in response to sounds, in level with LDL:s.	Evaluation for participance (day one), before treatment for waiting list patients (up to	No