Treatment of Misophonia: Comparison of Exposure and Sound Therapy

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05993286

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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;

Psychoeducation
Psychoeducation + Exposure
Psychoeducation + Sound Therapy

Condition or Disease	Intervention/Treatment	Phase
Misophonia	Behavioral: Exposure Therapy Other: Sound Therapy Other: Psychoeducation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Treatment of Misophonia: Comparison of Exposure and Sound Therapy

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

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

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.

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: Psychoeducation

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

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: 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.

Other: Psychoeducation

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

Outcome Measures

Primary Outcome Measures

The mean change in Misophonia Total Score (MTS) [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.
The "improvement" [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University Department of Psychiatry	Ankara		Turkey	06000

Sponsors and Collaborators

Hacettepe University

Investigators

Study Director: Cengiz Kılıç, Prof., Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kezban Burcu Avanoğlu, Consultant, Hacettepe University

ClinicalTrials.gov Identifier:

NCT05993286

Other Study ID Numbers:

16969557

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kezban Burcu Avanoğlu, Consultant, Hacettepe University

Study Results

No Results Posted as of Aug 15, 2023