Exploring Two Treatments for Misophonia

Misophonia Clinical Trial

Official title:

Exploring Two CBT-based Treatments as Interventions for Emotion Dysregulation in Misophonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198597
• Other study ID #: Pro00103962
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: November 21, 2022

Study information

• Verified date: December 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help reduce symptoms associated with Misophonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over age 18

• Able to read English

• Meet criteria for interfering symptoms of misophonia

• Live in North Carolina

Exclusion Criteria:

• Under age 18

• Current mania

• Current psychotic disorder

• Current anorexia

• Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)

• Has received any treatment specifically for misophonia in the past year

Related Conditions & MeSH terms

• Misophonia

Intervention

Behavioral:
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Please see arm/group descriptions
• Process-based Cognitive Behavioral Therapy
Please see arm/group descriptions

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ)	The CEQ is a 6-item measure that asks patients about their perceptions of treatment.	up to 20 weeks
Primary	Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)	This form has two questions that assess how satisfied patients were with treatment and how acceptable treatment was to them. The remaining three items are open ended questions that allow patients to provide narrative feedback about their experience in treatment.	up to 20 weeks
Secondary	Change in misophonia symptoms as assessed by the Misophonia Questionnaire	The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities).	assessed weekly, up to 24 weeks
Secondary	Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale	The Overall Anxiety Severity and Impairment Scale is a five item measure that assesses interference and distress related to the experience of anxiety. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.	assessed weekly, up to 24 weeks
Secondary	Change in depression as measured by the Overall Depression Severity and Impairment Scale	The Overall Depression Severity and Impairment Scale is a five item measure that assesses interference and distress in an individual's day-to-day life related to the experience of depression. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.	assessed weekly, up to 24 weeks
Secondary	Change in anger as measured by the Clinical Anger Scale	The Clinical Anger Scale is a 21-item measure that assesses the severity of anger-related symptoms (e.g., current anger, anger about the future).Items are scored from 0 to 3 and summed to produce a total score (ranging from 0 - 63), with higher scores indicating greater anger-related symptoms.	assessed weekly, up to 24 weeks
Secondary	Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire	The Skill Use Questionnaire is a four-item measure that assesses the extent to which patients use the skills taught in therapy and find them to be helpful.	assessed weekly, up to 24 weeks