Digital Intervention for Adults With Misophonia: A Randomized Controlled Trial

October 21, 2025 updated by: Utah State University

Efficacy and Feasibility of an Online Acceptance Based Intervention for Misophonia: A Randomized Controlled Trial

The goal of this clinical trial is to test an online intervention for adults with misophonia. The main questions it aims to answer are:

  1. Is the online intervention effective, compared to a waitlist control condition?
  2. Is the online intervention acceptable to use?

Participants will be randomized into either the online intervention or waitlist control condition:

  1. Participants in the intervention condition will be asked to complete an 8 module acceptance and commitment therapy (ACT) program for misophonia and 5 surveys over 4 months.
  2. Participants in the waitlist condition will be asked to complete 5 surveys over 4 months, and will receive access to the intervention once the study is complete.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Misophonia, characterized by intense emotional reactions to specific sounds, significantly impacts daily functioning and quality of life. Acceptance and Commitment Therapy (ACT) has shown promise in addressing misophonia symptoms by fostering psychological flexibility. While recent intervention studies demonstrate the efficacy of ACT for misophonia, accessible and scalable treatment options remain scarce. This study aims to address this gap by developing and evaluating a fully automated, online ACT-based digital mental health intervention for misophonia. We will compare the intervention to a delayed treatment group in a sample of 100 adults meeting clinical criteria for misophonia. Outcomes will include misophonia symptoms, quality of life, general distress, and psychological flexibility, assessed at baseline, mid-intervention, post-intervention, and one- and two-month follow-up. Multilevel modeling will test time by condition interactions to examine the efficacy and feasibility of an online ACT-based intervention. This fully automated online intervention aims to provide accessible, evidence-based treatment for individuals with misophonia, laying groundwork for future, larger-scale studies and public dissemination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Logan, Utah, United States, 84321
        • Recruiting
        • Utah State University
        • Contact:
        • Principal Investigator:
          • Emily M Bowers, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Currently meet clinical impairment for misophonia.
  • At least 18 years old.
  • Fluent English speakers.
  • Currently live or reside in the United States

Exclusion Criteria:

  • Currently receiving alternative psychotherapy for misophonia.
  • Currently modifying or starting psychotropic medication (within 30 days of starting the study).
  • Any psychological and/or neurological impairments that would preclude someone from participating in the study (e.g.,active self-harm or psychosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT online program
Participants will complete the 8-module fully automated digital intervention based in acceptance and commitment therapy (ACT).
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.
Other Names:
  • ACT
No Intervention: Waitlist Control
Waitlist condition; assessment only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Misophonia acceptance and action questionnaire (Miso-AAQ; Capel et al., 2025)
Time Frame: 16 weeks
The Miso-AAQ is a 7-item self-report measure of misophonia-specific psychological inflexibility, adapted from the AAQ-III (Ong et al., 2019). Items (e.g., "I'm so afraid of my reactions to sounds that I don't do things I care about" are rated from 1 (never true) to 7 (always true) Likert scale. Total scores range from 7 to 49 with higher scores indicating greater misophonia-specific psychological inflexibility. Preliminary validation from a treatment seeking sample of adults with misophonia suggest good internal consistency and convergent validity (Capel et al., 2025).
16 weeks
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016)
Time Frame: 16 weeks
The CompACT is a 23-item self-report measure of psychological flexibility. Items (e.g., "I make choices based on what is important to me, even if it is stressful) are rated on a 7-point Likert scale from 0 (strongly disagree) to 6 (strongly agree), with 12 items reverse-scored. Total scores range from 0 to 138 with higher scores indicating greater psychological flexibility. The CompACT demonstrates good internal consistency and convergent validity (Francis et al., 2016).
16 weeks
Depression Anxiety Stress Scale (DASS-21; Lovibond & Lovibond, 1995)
Time Frame: 16 weeks
The DASS-21 is a 21 item self-report measure of distress comprised of three 7-item subscales: (1) depression, (2) anxiety, and (3) stress. Items are rated from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), with higher scores indicating greater symptom severity. Subscale scores are summed and multiplied by two, yielding scores ranging from 0-42 for each subscale.
16 weeks
Mental Health Continuum-Short Form (MHC-SF; Keyes, 2005)
Time Frame: 16 weeks
The MHC-SF is a 14-item self-report measure of well-being. Items assess emotional, social, and psychological well-being, rated on a 6-point Likert scale from 0 (never) to 5 (every day). A total score is calculated from summing all items and ranges from 0 to 70, with higher scores reflecting greater well-being. The MHC-SF has demonstrated strong internal consistency and validity in prior studies (Lamers et al., 2011).
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Internalized Health-Related Stigma Scale (I-HEARTS; Pearl et al., 2024)
Time Frame: 16 weeks
The I-HEARTS is a 25-item self-report measure assessing internalized health-related stigma, adapted here to reference misophonia specifically. Items (e.g., "I am embarrassed or ashamed that I have misophonia") are rated on a 1 (strongly disagree) to 7 (strongly agree) Likert scale, with higher scores indicating greater internalized stigma. The scale yields a total score and three subscales: (1) perceived and anticipated stigma, (2) stereotype application and self-devaluation, and (3) stigma resistance (reverse-scored). Validation in a large sample of adults with chronic health conditions demonstrated strong internal consistency, test-retest reliability, and convergent validity with related constructs such as shame, loneliness, and depression (Pearl et al., 2024).
16 weeks
Interpersonal Reactivity Index - Perspective Taking (IRI-PT; Davis, 1980)
Time Frame: 16 weeks
The IRI-PT is a 7-item self-report subscale assessing the tendency to adopt others' psychological perspectives. Items (e.g., "Before criticizing somebody, I try to imagine how I would feel if I were in their place") are rated from 0 (does not describe me well) to 4 (describes me very well). Total scores range from 0 to 28, with higher scores indicating greater perspective-taking propensity. The IRI-PT has demonstrated good internal consistency and validity as a measure of perspective taking (Davis, 1980).
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Utah State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Misophonia Research Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily M Bowers, M.S., Utah State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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