"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."

Development and evaluation of a multi-sensory VR-based intervention for improving sound tolerance in misophonia, assessing its effects on emotional regulation to auditory triggers, and reducing auditory avoidance while improving social functioning.

Randomized, controlled, parallel-group, open-label superiority clinical trial with 32 participants. Allocation will be performed in a 1:1 ratio using block randomization (block size = 3). The randomization sequence will be generated using the Sealed Envelope online randomization service.

This is a randomized clinical trial in two phases. Phase one involves the development of a multidimensional VR-based protocol including graded sound therapy and psychophysiological regulation. In phase two, participants (18–60 years) are randomized into CBT (control) and VR-based intervention groups. Outcomes (PHQ-9, GAD-7, MQ, VAS) are assessed at multiple time points, and VR safety is monitored.

Inclusion: Age 18–60, normal hearing and ear exams, confirmed reduced sound tolerance (SSSQ/MQ), no major neuropsychiatric disorders, and poor response to prior treatments. Exclusion: New hearing loss, LDL <40 dB, VR intolerance (e.g., epilepsy/Meniere's), new medications, non-compliance, symptom worsening, or pregnancy.

Control Group: Participants received conventional Cognitive Behavioral Therapy (CBT).Intervention Group: Participants receiving Multisensory Virtual Reality (MSVR) therapy.

MQ (Misophonia Questionnaire) ,Visual Analog Scale (VAS), GAD, PHQ-9

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.

All data, after being de-identified, are potentially shareable.

The data access period will begin 6 months after publication of the study results.

It will be available to researchers affiliated with academic and scientific institutions.

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.

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

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.