Study of brain activity in misophonia and the effect of cognitive behavioral therapy

Not Applicable

Completed

• Conditions: Misophonia; Mental and Behavioural Disorders

• Registration Number: ISRCTN12571777
• Lead Sponsor: Academic Medical Center

Brief Summary

2019 fMRI substudy results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6525165/ (added 16/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-04-04
• Study Start: 2016-10-28
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patient inclusion criteria:
1. Meet the diagnostic criteria for misophonia, as proposed by Schröder and Denys
2. Male and female, aged above 18 years
3. Female patients of childbearing potential must have a negative pregnancy test and use reliable method of contraception
4. Written informed consent
5. Eligible for exposure therapy

Healthy control inclusion criteria:
1. Age between 18 and 65
2. Subjects have signed informed consent in accordance with the provisions of the pertinent excerpt from the Declaration of Helsinki (October, 2000) and Dutch legal regulation (Wet Medisch Wetenschappelijk Onderzoek met Mensen).
3. No current or past psychiatric disorders

For the fMRI study an additional criterion has been established:
Age between 18 and 65

Exclusion Criteria

1. Presence of any of the following DSM IV conditions:
1.1. Major depression
1.2. Major anxiety disorder
1.3. Bipolar Disorder
1.4. Autism Spectrum Disorders
1.5. Schizophrenia or any other psychotic disorder
1.6. Substance related disorder during the past 6 months
1.7. Epilepsy or any structural CNS disorder of stroke within the last year
2. Evidence of clinically significant and unstable cardiovascular, gastrointestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year or micturition abnormalities
3. Currently taking benzodiazepines, antidepressants or stimulants
4. Patients at risk for suicide
5. Inability to speak Dutch or English

For the fMRI study four additional criteria have been established:
1. Ferrous objects in or around the body (e.g. braces, glasses, pacemaker, metal fragments)
2. Drug or alcohol abuse over a period of six months prior to the experiment
3. History of closed-head injury
4. Patients with claustrophobia

Study & Design

• Study Type: Interventional
• Study Design: Not specified