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Cognitive Behavioral Therapy for Hyperacusis

Primary Purpose

Hyperacusis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperacusis focused on measuring Hyperacusis, Personality, Comorbidity, Treatment, Cognitive behavioral therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive behavioural therapy (CBT)

Waiting list

Arm Description

Patients receiving 6 sessions of CBT conducted by a licensed psychologist. Sessions include psychoeducation, exposure treatment, behavioral activation and applied relaxation.

Patient waits for CBT treatment for 6 months.

Outcomes

Primary Outcome Measures

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.
Khalfa Hyperacusis Questionnaire
A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.
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.

Secondary Outcome Measures

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.
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.
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.
Startle-response
Heart rate and skin conductance measured in response to sounds, in level with LDL:s.

Full Information

First Posted
March 23, 2011
Last Updated
May 24, 2014
Sponsor
Linkoeping University
Collaborators
Uppsala University, Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01321814
Brief Title
Cognitive Behavioral Therapy for Hyperacusis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Uppsala University, Uppsala University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperacusis
Keywords
Hyperacusis, Personality, Comorbidity, Treatment, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural therapy (CBT)
Arm Type
Experimental
Arm Description
Patients receiving 6 sessions of CBT conducted by a licensed psychologist. Sessions include psychoeducation, exposure treatment, behavioral activation and applied relaxation.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Patient waits for CBT treatment for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
Primary Outcome Measure Information:
Title
Quality of Life Inventory (QOLI)
Description
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.
Time Frame
Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Title
Khalfa Hyperacusis Questionnaire
Description
A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.
Time Frame
Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Title
Loudness discomfort threshold
Description
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
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 Outcome Measure Information:
Title
The Mini-International Neuropsychiatric Interview (M.I.N.I)
Description
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.
Time Frame
At evaluation for participance (day one)
Title
Swedish universities Scales of Personality (SSP)
Description
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.
Time Frame
At evaluation for participance (day one)
Title
Tampa scale of Kinesiophobia - for Hyperacusis
Description
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.
Time Frame
Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
Title
Startle-response
Description
Heart rate and skin conductance measured in response to sounds, in level with LDL:s.
Time Frame
Evaluation for participance (day one), before treatment for waiting list patients (up to

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ekselius, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans C Larsen, Reader
Organizational Affiliation
Uppsala University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Linda Jüris, PhD Student
Organizational Affiliation
Uppsala University/ Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

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Cognitive Behavioral Therapy for Hyperacusis

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