Cognitive Behavioral Therapy for Hyperacusis

This study has been completed.
Sponsor:
Collaborators:
Uppsala University
Uppsala University Hospital
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01321814
First received: March 23, 2011
Last updated: May 24, 2014
Last verified: May 2014
  Purpose

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 Intervention
Hyperacusis
Behavioral: Cognitive behavioural therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Mini-International Neuropsychiatric Interview (M.I.N.I) [ Time Frame: At evaluation for participance (day one) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Heart rate and skin conductance measured in response to sounds, in level with LDL:s.


Enrollment: 62
Study Start Date: June 2004
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321814

Locations
Sweden
Uppsala, Sweden, 75185
Sponsors and Collaborators
Linkoeping University
Uppsala University
Uppsala University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01321814     History of Changes
Other Study ID Numbers: GA-LJ-HYP1
Study First Received: March 23, 2011
Last Updated: May 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Hyperacusis
Personality
Comorbidity
Treatment
Cognitive behavioral therapy

Additional relevant MeSH terms:
Hyperacusis
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014