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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05993286
Other study ID # 16969557
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date April 1, 2021

Study information

Verified date August 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of possible treatments in misophonics. The main question it aims to answer is: - Is exposure more effective on misophonic symptoms than sound therapy? Participants are randomly assinged to three groups of treatment; 1. Psychoeducation 2. Psychoeducation + Exposure 3. Psychoeducation + Sound Therapy


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - People have Misophonia Exclusion Criteria: - Current psychosis - Mental retardation or dementia - those who had previously received exposure or sound therapy for misophonia symptoms.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure Therapy
At Week 0, the homework was to expose oneself to these sounds for 20 minutes a day, three days a week for three weeks. At the Week 3 interview, the frequency and severity of the homework were adjusted based on the degree of improvement in the symptoms and the person's adherence to the instructions.
Other:
Sound Therapy
Participants were asked to listen to specifically modulated music for twenty minutes a day, three days a week, for the first three weeks. At the Week 3 assessment, if the patient reported no or little benefit in their misophonia symptoms, the instruction was modified (intensified) to listening to the same music for forty minutes a day, three days a week.
Psychoeducation
A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.

Locations

Country Name City State
Turkey Hacettepe University Department of Psychiatry Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Jager IJ, Vulink NCC, Bergfeld IO, van Loon AJJM, Denys DAJP. Cognitive behavioral therapy for misophonia: A randomized clinical trial. Depress Anxiety. 2020 Dec 18;38(7):708-18. doi: 10.1002/da.23127. Online ahead of print. — View Citation

Kilic C, Oz G, Avanoglu KB, Aksoy S. The prevalence and characteristics of misophonia in Ankara, Turkey: population-based study. BJPsych Open. 2021 Aug 6;7(5):e144. doi: 10.1192/bjo.2021.978. — View Citation

Swedo SE, Baguley DM, Denys D, Dixon LJ, Erfanian M, Fioretti A, Jastreboff PJ, Kumar S, Rosenthal MZ, Rouw R, Schiller D, Simner J, Storch EA, Taylor S, Werff KRV, Altimus CM, Raver SM. Consensus Definition of Misophonia: A Delphi Study. Front Neurosci. 2022 Mar 17;16:841816. doi: 10.3389/fnins.2022.841816. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The mean change in Misophonia Total Score (MTS) The difference between MTS Week 0 and MTS Week 6 was calculated, divided by MTS Week 0, and multiplied by 100, to elicit the percent change in MTS between Week 0 and Week 6. Week 0 and Week 6
Primary The "improvement" It was rated by the investigator (KBA) based on her clinical judgement (0=some worsening, 1=no improvement, 2=some improvement, 3=moderate improvement, 4=much improvement). If there was a moderate to much improvement at any point, the case was rated as "improved"; and "not improved" if the score was little worsening, no improvement, or some improvement. Week 3 and Week 6
See also
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Enrolling by invitation NCT05928689 - Behavioral and Pharmacological Reconsolidation Interference in Misophonia Early Phase 1
Completed NCT04612374 - Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia N/A
Recruiting NCT04365543 - Treatment for Youth (Ages 8 to 16 Years Old) With Misophonia (U-HEAR) N/A