Treatment of Misophonia: Comparison of Exposure and Sound Therapy

August 7, 2023 updated by: Kezban Burcu Avanoğlu, Hacettepe University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Hacettepe University Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Psychoeducation
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
A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.
Experimental: Exposure Therapy and Psychoeducation
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.
Other: Psychoeducation
A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.
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.
Active Comparator: Sound Therapy and Psychoeducation
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: Psychoeducation
A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean change in Misophonia Total Score (MTS)
Time Frame: Week 0 and Week 6
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"
Time Frame: Week 3 and Week 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Cengiz Kılıç, Prof., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16969557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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