MisophoniaNCT05993286
Treatment of Misophonia: Comparison of Exposure and Sound Therapy
A study testing Exposure Therapy, Sound Therapy and Psychoeducation in people with Misophonia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Misophonia
- What is being tested?
- Exposure Therapy, Sound Therapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People have Misophonia
Who cannot join
- Current psychosis
- Mental retardation or dementia
- those who had previously received exposure or sound therapy for misophonia symptoms.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Department of Psychiatry
Ankara, 06000
About this study
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
- Conditions
- Misophonia
- Being tested
- Exposure Therapy, Sound Therapy, Psychoeducation
- Keywords
- Misophonia, sound therapy, exposure, psychoeducation, treatment
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure TherapyBehavioural
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.
Sound TherapyOther
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.
PsychoeducationOther
A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exposure Therapy; Other: 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 Receives: Other: Sound Therapy; Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Mar 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MisophoniaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kezban Burcu Avanoğlu, Hacettepe University
- Investigators
- Cengiz Kılıç, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993286
- Sponsor's protocol ID
- 16969557
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35368272Kilic 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.
PubMed 34353403Jager 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.
PubMed 33336858
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Misophonia: Comparison of Exposure and Sound Therapy
- ClinicalTrials.gov ID
- NCT05993286
- Acronym / sponsor ID
- 16969557
- Conditions
- Misophonia
- Keywords
- Misophonia, sound therapy, exposure, psychoeducation, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Other | Other: PsychoeducationThis 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. |
| Exposure Therapy and Psychoeducation | Experimental | Behavioral: Exposure Therapy, Other: PsychoeducationExposure 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. |
| Sound Therapy and Psychoeducation | Active comparator | Other: Sound Therapy, Other: PsychoeducationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People have Misophonia
Key exclusion criteria (3 listed)
- Current psychosis
- Mental retardation or dementia
- those who had previously received exposure or sound therapy for misophonia symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure TherapyAt 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. | Behavioural | Exposure Therapy and Psychoeducation |
| Sound TherapyParticipants 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 | Sound Therapy and Psychoeducation |
| PsychoeducationA psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake. | Other | Exposure Therapy and Psychoeducation, Psychoeducation, Sound Therapy and Psychoeducation |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 35368272Swedo 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.
- Background: PubMed 34353403Kilic 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.
- Results publication: PubMed 33336858Jager 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cengiz Kılıç, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy, Sound Therapy and Psychoeducation in people with Misophonia, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in Misophonia Total Score (MTS) (time frame: Week 0 and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.