Misophonia Mental and Behavioural Disorders Misophonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Misophonia symptom severity is measured with the Amsterdam Misophonia Scale (A-MISO-S) and Clinical Global Impression Scale (CGI) at first interview at baseline, 5, 10 and 28 weeks 2. Cortical brain activity is measured using Electroencephalography (EEG), using an auditory mismatch negativity (MMN) paradigm, at baseline and 10 weeks 3. Genetic clarification for misophonia and the effect of treatment is assessed using DNA samples, which will be collected for epigenetic analysis in patients by peripheral blood samples taken at baseline and 10 weeks fMRI study: 1. Change in BOLD activation in patients will be measured at baseline (before treatment) and week 10 (after treatment) 2. Differences in BOLD activation between patients and controls will be examined at baseline and week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety and depression symptoms will be assessed using the Hamilton Anxiety Rating Scale (HARS) and Hamilton Depression Rating Scale (HDRS) at first interview at baseline, 5, 10 and 28 weeks 2. Psychopathology will be measured using the Symptom Checklist (SCL-90R) at first interview at baseline, 5, 10 and 28 weeks 3. Social avoidance and aggressiveness will be assessed with the Inventarisatielijst Omgaan met Anderen (IOA) and Agressie Vragenlijst (AVL) at first interview at baseline, 5, 10 and 28 weeks | — |
Countries
Netherlands