xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993286</url>
    </required_header>
    <id_info>
      <org_study_id>16969557</org_study_id>
      <nct_id>NCT05993286</nct_id>
    </id_info>
    <brief_title>Treatment of Misophonia: Comparison of Exposure and Sound Therapy</brief_title>
    <official_title>Treatment of Misophonia: Comparison of Exposure and Sound Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effects of possible treatments in&#xD;
        misophonics. The main question it aims to answer is:&#xD;
  &#xD;
        - Is exposure more effective on misophonic symptoms than sound therapy? Participants are&#xD;
        randomly assinged to three groups of treatment;&#xD;
  &#xD;
          1. Psychoeducation&#xD;
  &#xD;
          2. Psychoeducation + Exposure&#xD;
  &#xD;
          3. Psychoeducation + Sound Therapy&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2019</start_date>
    <completion_date type="Actual">April 1, 2021</completion_date>
    <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The mean change in Misophonia Total Score (MTS)</measure>
      <time_frame>Week 0 and Week 6</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The &quot;improvement&quot;</measure>
      <time_frame>Week 3 and Week 6</time_frame>
      <description>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 &quot;improved&quot;; and &quot;not improved&quot; if the score was little worsening, no improvement, or some improvement.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">76</enrollment>
    <condition>Misophonia</condition>
    <arm_group>
      <arm_group_label>Psychoeducation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exposure Therapy and Psychoeducation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sound Therapy and Psychoeducation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exposure Therapy</intervention_name>
      <description>At Week 0, the homework was to expose oneself to these sounds for 20 minutes a day, three days a week for three weeks.&#xD;
  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.</description>
      <arm_group_label>Exposure Therapy and Psychoeducation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sound Therapy</intervention_name>
      <description>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.</description>
      <arm_group_label>Sound Therapy and Psychoeducation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychoeducation</intervention_name>
      <description>A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.</description>
      <arm_group_label>Exposure Therapy and Psychoeducation</arm_group_label>
      <arm_group_label>Psychoeducation</arm_group_label>
      <arm_group_label>Sound Therapy and Psychoeducation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People have Misophonia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current psychosis&#xD;
  &#xD;
            -  Mental retardation or dementia&#xD;
  &#xD;
            -  those who had previously received exposure or sound therapy for misophonia symptoms.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cengiz Kılıç, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hacettepe University Department of Psychiatry</name>
        <address>
          <city>Ankara</city>
          <zip>06000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>35368272</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>34353403</PMID>
    </reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>33336858</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Kezban Burcu Avanoğlu</investigator_full_name>
      <investigator_title>Consultant</investigator_title>
    </responsible_party>
    <keyword>Misophonia</keyword>
    <keyword>sound therapy</keyword>
    <keyword>exposure</keyword>
    <keyword>psychoeducation</keyword>
    <keyword>treatment</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993286
  org study id: 16969557
  nct id: NCT05993286
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The mean change in Misophonia Total Score (MTS)
  time frame: Week 0 and Week 6
  description: 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.
  measure: The "improvement"
  time frame: Week 3 and Week 6
  description: 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.
  arm group label: Psychoeducation
  arm group type: Other
  description: 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.
  arm group label: Exposure Therapy and Psychoeducation
  arm group type: Experimental
  description: 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.
  arm group label: Sound Therapy and Psychoeducation
  arm group type: Active Comparator
  description: 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
  intervention type: Behavioral
  intervention name: Exposure Therapy
  description: 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.
  arm group label: Exposure Therapy and Psychoeducation
  intervention type: Other
  intervention name: Sound Therapy
  description: 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.
  arm group label: Sound Therapy and Psychoeducation
  intervention type: Other
  intervention name: Psychoeducation
  description: A psychoeducation session, prepared by the research team was delivered by the investigator to each patient at the study intake.
  arm group label: Exposure Therapy and Psychoeducation
  arm group label: Psychoeducation
  arm group label: Sound Therapy and Psychoeducation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cengiz Kılıç, Prof.
  role: Study Director
  affiliation: Hacettepe University
  facility: 
  country: Turkey
  citation: 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.
  PMID: 35368272
  citation: 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.
  PMID: 34353403
  citation: 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.
  PMID: 33336858
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Kezban Burcu Avanoğlu
  investigator title: Consultant
  sharing ipd: No