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Treatment of Misophonia: Comparison of Exposure and Sound Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05993286
Recruitment Status : Completed
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Kezban Burcu Avanoğlu, Hacettepe University

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

Condition or disease Intervention/treatment Phase
Misophonia Behavioral: Exposure Therapy Other: Sound Therapy Other: Psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Misophonia: Comparison of Exposure and Sound Therapy
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993286


Locations
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Turkey
Hacettepe University Department of Psychiatry
Ankara, Turkey, 06000
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Cengiz Kılıç, Prof. Hacettepe University
Publications of Results:
Other Publications:
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Responsible Party: Kezban Burcu Avanoğlu, Consultant, Hacettepe University
ClinicalTrials.gov Identifier: NCT05993286    
Other Study ID Numbers: 16969557
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kezban Burcu Avanoğlu, Hacettepe University:
Misophonia
sound therapy
exposure
psychoeducation
treatment