Cognitive Behavioral Therapy for Hyperacusis

NCT ID: NCT01321814

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Hyperacusis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavioural therapy

Intervention Type: BEHAVIORAL

6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.

Waiting list

Patient waits for CBT treatment for 6 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive behavioural therapy

6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gerhard Andersson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Ekselius, Professor

Role: STUDY_DIRECTOR

Uppsala University

Gerhard Andersson, Professor

Role: STUDY_CHAIR

Linkoeping University

Hans C Larsen, Reader

Role: STUDY_CHAIR

Uppsala University Hospital

Linda Jüris, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Uppsala University/ Uppsala University Hospital

Locations

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

GA-LJ-HYP1

Identifier Type: -

Identifier Source: org_study_id