Cognitive Behavioral Therapy for Hyperacusis

NCT01321814 | Completed

• 1 other identifier: GA-LJ-HYP1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperacusis

Keywords

Hyperacusis; Personality; Comorbidity; Treatment; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment

• Khalfa Hyperacusis Questionnaire

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

  Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment

• 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.

  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 Outcomes (4)

• The Mini-International Neuropsychiatric Interview (M.I.N.I)

  At evaluation for participance (day one)

• Swedish universities Scales of Personality (SSP)

  At evaluation for participance (day one)

• Tampa scale of Kinesiophobia - for Hyperacusis

  Evaluation for participance (day one), before treatment for waiting list patients (up to 6 months), direct after treatment, 12 mts after treatment

• Startle-response

  Evaluation for participance (day one), before treatment for waiting list patients (up to

Study Arms (2)

Cognitive behavioural therapy (CBT)

EXPERIMENTAL

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

Waiting list

NO INTERVENTION

Patient waits for CBT treatment for 6 months.

Interventions

Cognitive behavioural therapy BEHAVIORAL

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

Cognitive behavioural therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Scoring "moderate" or "high" on suicidality, according to M.I.N.I
• Moderate to severe depression
• Psychotic disorders

Sponsors & Collaborators

• Linkoeping University: lead
• Uppsala University: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Unknown Facility

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Hyperacusis

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa Ekselius, Professor

  Uppsala University

  STUDY DIRECTOR

• Gerhard Andersson, Professor

  Linkoeping University

  STUDY CHAIR

• Hans C Larsen, Reader

  Uppsala University Hospital

  STUDY CHAIR

• Linda Jüris, PhD Student

  Uppsala University/ Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: June 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

SE (1)