Digital Intervention for Adults With Misophonia: A Randomized Controlled Trial

BEHAVIORAL

Acceptance and commitment therapy

Participants will complete the 8-module fully automated digital intervention based in acceptance and commitment therapy (ACT). The digital program is based off of an ACT protocol developed in a prior randomized controlled trial and adapted for digital self-help use (Bowers et al., 2024). Modules focus on focus on acceptance, cognitive defusion, present moment awareness, values clarification, and functional adaptations.

Selective Sound Sensitivity Syndrome Scale (S-Five; Vitoratou et al., 2021)

Time frame: 16 weeks

The S-Five is a 25-item self-report measure of misophonia severity. Items (e.g., "I feel trapped if I cannot get away from certain noises") are rated on a 0 (not at all true) to 10 (completely true) ordinal scale with total scores ranging from 0 to 250. The S-Five consists of five latent factors: (1) externalizing appraisals (e.g., blaming others for making sounds), (2) internalizing appraisals (e.g., negative self-judgments triggered by misophonia), (3) impact on functioning (e.g., social and occupational impact), (4) outburst (e.g., experiences of aggression or fear of losing control), and (5) threat (e.g., feeling trapped or helpless). The S-Five demonstrates good internal consistency and convergent validity with other misophonia measures (Vitoratou et al., 2023).

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.