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IRCT20231013059701N2 IRCT 2026-07-01 Tehran University of Medical Sciences "Comparing the effectiveness of cognitive-behavioral and acceptance and commitment therapies in conventional and virtual reality-based methods on reducing sound annoyance in adults with misophonia." "Comparing the effectiveness of cognitive-behavioral and acceptance and commitment therapies in conventional and virtual reality-based methods on reducing sound annoyance in adults with misophonia." 2026-07-23 anticipated 32 Recruiting https://irct.ir/trial/91039 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: ### Type of TrialThis study is designed as a **superiority randomized controlled trial (RCT)**. A superiority trial aims to determine whether a new intervention is significantly more effective than a standard treatment or control condition. In this design, the null hypothesis assumes that no difference exists between the two interventions, whereas the objective of the study is to reject the null hypothesis and demonstrate the superiority of the new intervention.Superiority trials are employed when the investigational treatment is expected to produce greater improvements in clinical outcomes compared with conventional approaches. This design is one of the most commonly used methodologies in interventional research and clinical trials, Randomization description: 3.2. Randomization Method All eligible participants will be allocated equally to the intervention and control groups using a block randomization method with a fixed block size of four, ensuring a 1:1 allocation ratio throughout the study. ### 3.3. Method Used to Generate the Random Allocation Sequence The randomization sequence will be generated using the online randomization service provided by Sealed Envelope Ltd. This system will be used to create a computer-generated allocation list according to the predefined block randomization scheme. N/A Decreased sound tolerance (misophonia ). Intervention 1: Intervention group: Individuals with misophonia receiving Cognitive Behavioral Therapy (CBT) combined with multi-sensory virtual reality (VR) intervention in 8 weekly 60-minute sessions. Intervention 2: Control group: Individuals with misophonia receiving Cognitive Behavioral Therapy (CBT) intervention in 8 weekly 60-minute sessions. Yes - There is a plan to make this available What will be shared: All data, after being de-identified, are potentially shareable. When: The data access period will begin 6 months after publication of the study results. To whom: It will be available to researchers affiliated with academic and scientific institutions. Conditions: Access to de-identified data is restricted to researchers affiliated with academic institutions and is subject to approval by the Research Ethics Committee. Data use is permitted solely within the scope of the approved research objectives for scientific and statistical analyses. Any commercial use or sharing with third parties is strictly prohibited. All data are provided in coded form, and confidentiality as well as adherence to research ethics principles is mandatory. Where to obtain: Eligible applicants may submit a formal request for access to data or study documents to the principal investigator. All requests will first be reviewed by the study investigator and, if approved, will be submitted for approval by the Research Ethics Committee. Official email of the principal investigator: skia171055@gmail.com, In-person correspondence: Faculty of Rehabilitation, Tehran University of Medical Sciences, Postal address: Faculty of Rehabilitation, Tehran University of Medical Sciences, Picheh Shemiran (Enghelab Street), Tehran, Iran, Telephone: +98 21 7753 0636. For further information, direct communication with the principal investigator is also available How to obtain: The applicant first submits a formal request along with a research proposal. After an initial review by the principal investigator and approval by the Research Ethics Committee, a data use agreement is signed, and the de-identified, coded data are provided. Estimated timeline:2–4 weeks, depending on the approval process. Comments:
public Somayeh Bakhtarikia
Tehran, Valiasr Street, before Towhid (Tavanir) intersection, corner of Bakhshandegan Alley, Arian Building, 1st floor, Unit 6.
Tehran Iran (Islamic Republic of) 1516745136 +98 21 8865 1856 skia171055@gmail.com Tehran University of Medical Sciences scientific Elham Tavanai
Tehran University of Medical Sciences, Faculty of Rehabilitation, Tehran Intersection (Picheh Shemiran), Enghelab Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 0636 etavanai@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 1. Adults aged 18–60 years. 2. Normal hearing thresholds and normal middle ear function. 3. Confirmation of decreased sound tolerance based on (SSSQ, clinical interview, and MQ). 4. Sufficient literacy to complete the study questionnaires. 5. No history of neurological disorders. 6. Inadequate response to conventional treatments during the previous six months. 18 years 60 years Both 1. Presence of specific hearing abnormalities . 2. Critically low Loudness Discomfort Levels (LDLs) . 3. History of cybersickness or intolerance. 4. Initiation of ototoxic medications or psychotropic medications. 5. Inability to comply with the study protocol. 6.Pregnancy. H93.2 Other abnormal auditory perceptions (including sound intolerance disorders without a specific ICD-10 code, such as misophonia). Rehabilitation Rehabilitation Intervention group: Individuals with misophonia receiving Cognitive Behavioral Therapy (CBT) combined with multi-sensory virtual reality (VR) intervention in 8 weekly 60-minute sessions. Control group: Individuals with misophonia receiving Cognitive Behavioral Therapy (CBT) intervention in 8 weekly 60-minute sessions. Misophonia Questionnaire Score. Timepoint: The misophonia questionnaire will be administered at baseline (pre-intervention), post-intervention (8 weeks), and at 1- and 3-month follow-ups after cognitive-behavioral therapy (CBT). Method of measurement: Completing the Misophonia Questionnaire. Visual Analog Scale score. Timepoint: Sound sensitivity scores (auditory exposure) will be assessed using a Visual Analogue Scale (VAS) at baseline (pre-intervention), post-intervention (8 weeks), and at 1- and 3-month follow-ups after cognitive-behavioral therapy (CBT). Method of measurement: Visual Analog Scale. Tehran University of Medical Sciences Approved 2026-06-17 Research Ethics Committee of the Faculty of Nursing and Midwifery, Tehran University of Medical Scie Tehran, Valiasr Street, before Towhid (Tavanir) intersection, corner of Bakhshandegan Alley, Arian Building, 1st floor, Unit 6 Tehran Tehran Iran (Islamic Republic of)