- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321814
Cognitive Behavioral Therapy for Hyperacusis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Uppsala, Sweden, 75185
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
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No Intervention: Waiting list
Patient waits for CBT treatment for 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
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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
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A questionnaire to quantify and evaluate various hyperacusis symptoms, screening several aspects of auditory symptomatology.
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Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
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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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Mini-International Neuropsychiatric Interview (M.I.N.I)
Time Frame: At evaluation for participance (day one)
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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.
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At evaluation for participance (day one)
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Swedish universities Scales of Personality (SSP)
Time Frame: At evaluation for participance (day one)
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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.
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At evaluation for participance (day one)
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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
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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.
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Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment
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Startle-response
Time Frame: Evaluation for participance (day one), before treatment for waiting list patients (up to
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Heart rate and skin conductance measured in response to sounds, in level with LDL:s.
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Evaluation for participance (day one), before treatment for waiting list patients (up to
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gerhard Andersson, Professor, Linkoeping University
- Study Director: Lisa Ekselius, Professor, Uppsala University
- Study Chair: Hans C Larsen, Reader, Uppsala University Hospital
- Principal Investigator: Linda Jüris, PhD Student, Uppsala University/ Uppsala University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA-LJ-HYP1
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