NCT05993286

Brief 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. 1.Psychoeducation
  2. 2.Psychoeducation + Exposure
  3. 3.Psychoeducation + Sound Therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

August 7, 2023

Last Update Submit

August 7, 2023

Conditions

Keywords

Misophoniasound therapyexposurepsychoeducationtreatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Psychoeducation

OTHER

This was an active control group and included information on the proposed mechanism of the development of misophonia, how symptoms are reinforced, and basic coping skills.

Other: Psychoeducation

Exposure Therapy and Psychoeducation

EXPERIMENTAL

Exposure has been successfully used in the treatment of anxiety disorders, phobias, and obsessions. There are also case reports showing its effectiveness in the treatment of misophonia. The proposed procedure is to expose the misophonic person to the triggering sound in a controlled and gradual manner until habituation/desensitization to the trigger occurs. In the current research setting, each participant was asked to choose the two misophonic sounds that are most disturbing.

Behavioral: Exposure TherapyOther: Psychoeducation

Sound Therapy and Psychoeducation

ACTIVE COMPARATOR

The music used in the current study was adapted from the protocol used by Jastreboff and Jastreboff (2013) for the treatment of misophonia. It includes noises such as white (noise with equal volume in all octaves) or pink noise (noise that decreases by 3 dB per octave towards high frequencies) or relaxing instrumental music

Other: Sound TherapyOther: Psychoeducation

Interventions

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.

Exposure Therapy and Psychoeducation

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.

Sound Therapy and Psychoeducation

A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.

Exposure Therapy and PsychoeducationPsychoeducationSound Therapy and Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People have Misophonia

You may not qualify if:

  • Current psychosis
  • Mental retardation or dementia
  • those who had previously received exposure or sound therapy for misophonia symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Department of Psychiatry

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 35368272BACKGROUND
  • 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.

    PMID: 34353403BACKGROUND
  • 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.

MeSH Terms

Conditions

misophonia

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cengiz Kılıç, Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three groups: psychoeducation only (the active control group), exposure therapy with psychoeducation, and sound therapy with psychoeducation. All participants were assessed at baseline, and then at 3rd and 6th weeks. All of them received psychoeducation at study intake. A random one third received no further active treatment, one third received exposure, and one third received sound therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

March 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations