We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychological Intervention for Misophonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05601284
Recruitment Status : Recruiting
First Posted : November 1, 2022
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Utah State University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Acceptance and commitment therapy (ACT) is a promising psychotherapy for supporting traditional behavioral methods for treating misophonia, but has not been previously tested. ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes. We are proposing to test ACT+ traditional audiological behavioral intervention as an integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Participants will be 40 adults with misophonia and will be randomly assigned to receive 12 sessions of ACT+behavioral intervention or receive 12 weeks of progressive relaxation training+psychoeducation (PRT; a commonly used active control condition) after undergoing a comprehensive psychological and audiological evaluation. This study will help determine if ACT+behavioral intervention is a feasible and acceptable treatment for misophonia, help clarify active psychological mechanisms of misophonia, and determine whether or not this combination of services can effectively help individuals diagnosed with misophonia.

Condition or disease Intervention/treatment Phase
Misophonia Behavioral: Acceptance and commitment therapy Behavioral: Progressive relaxation training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Intervention for Misophonia
Actual Study Start Date : October 24, 2022
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Acceptance and commitment therapy Behavioral: Acceptance and commitment therapy
ACT teaches skills to develop acceptance, mindfulness, and defusion from difficult internal experiences while increasing connections with personal values and encouraging meaningful behavioral changes. ACT for misophonia combines core ACT processes with a traditional audiological behavioral intervention for a integrated, multi-disciplinary approach for the assessment and treatment of misophonia. Treatment begins with a brief focus on the behavioral intervention, followed by the teaching of ACT skills to support the use of the behavioral methods. The intervention consists of 12 total individual sessions of ACT+behavioral management.
Other Name: ACT
Active Comparator: Progressive relaxation training Behavioral: Progressive relaxation training
PRT for misophonia consists of basic psychoeducation for misophonia followed by PRT. PRT involves learning to tense and relax muscles. Early sessions focus on tensing and relaxing smaller muscle groups, while later sessions focus on larger muscle groups. Final sessions focus on relaxation as produced by recalling previous relaxation and a review of skills learned. PRT consists of 12 individual total sessions.
Other Name: PRT


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Misophonia Questionnaire [ Time Frame: 9-12 months ]
    Self-report of misophonia symptoms


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals seeking treatment for misophonia.
  • Meet clinical cut-off for misphonia (minimum score of five on the Misophonia Questionnaire).
  • Stable on psychotropic medication for at least 30 days.
  • English speaking.

Exclusion Criteria:

  • Presence of psychological and/or neurological impairments that would preclude someone from participating in the study or exceed misophonia as the primary presenting problem (e.g. active self-harm or need for treatment for psychosis).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05601284


Contacts
Layout table for location contacts
Contact: Mercedes Woolley, BA 3859551049 mercedes.woolley@usu.edu
Contact: Michael Twohig, PhD michael.twohig@usu.edu

Locations
Layout table for location information
United States, Utah
Utah State University Recruiting
Logan, Utah, United States, 84341
Contact: Mercedes Woolley    385-955-1049    mercedes.woolley@usu.edu   
Principal Investigator: Michael Twohig, PhD         
Sponsors and Collaborators
Utah State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Utah State University
ClinicalTrials.gov Identifier: NCT05601284    
Other Study ID Numbers: 12981
First Posted: November 1, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No