Cognitive Behavioral Therapy for Hyperacusis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Linkoeping University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Uppsala University
Uppsala University Hospital
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01321814
First received: March 23, 2011
Last updated: October 13, 2011
Last verified: February 2011
  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
Estimated 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.

  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
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: Lisa Ekselius, professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01321814     History of Changes
Other Study ID Numbers: GA-LJ-HYP1
Study First Received: March 23, 2011
Last Updated: October 13, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014