Treatment of Misophonia: Comparison of Exposure and Sound Therapy

• ClinicalTrials.gov Identifier: NCT05993286
• Recruitment Status: Completed
• First Posted: August 15, 2023
• Last Update Posted: August 15, 2023
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Kezban Burcu Avanoğlu, Hacettepe University

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;

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Turkey

Hacettepe University Department of Psychiatry

Ankara, Turkey, 06000

Sponsors and Collaborators

Hacettepe University

Investigators

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

More Information

Publications of Results:

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.

Other Publications:

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.

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.

• Responsible Party: Kezban Burcu Avanoğlu, Consultant, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05993286
• Other Study ID Numbers: 16969557
• First Posted: August 15, 2023
• Last Update Posted: August 15, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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