Exploring Two Treatments for Misophonia

Not Applicable

Completed

• Conditions: Misophonia
• Interventions: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Behavioral: Process-based Cognitive Behavioral Therapy

• Registration Number: NCT04198597
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-09-11
• Status Verified: 2021-12
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Over age 18
• Able to read English
• Meet criteria for interfering symptoms of misophonia
• Live in North Carolina

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unified Protocol, 2 week baseline	Unified Protocol for Transdiagnostic Treatment of Emotional Disorders	Participants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences.
Unified Protocol, 4 week baseline	Unified Protocol for Transdiagnostic Treatment of Emotional Disorders	Participants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences.
Process-based treatment, 2 week baseline	Process-based Cognitive Behavioral Therapy	Participants in this arm will complete two weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized.
Process-based treatment, 4 week baseline	Process-based Cognitive Behavioral Therapy	Participants in this arm will complete four weeks of baseline assessment (during which they will complete questionnaires but not start treatment) and then receive 16 sessions of the process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized.

Primary Outcome Measures

Name	Time	Method
Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)	up to 20 weeks	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.
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ)	up to 20 weeks	The CEQ is a 6-item measure that asks patients about their perceptions of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in misophonia symptoms as assessed by the Misophonia Questionnaire	assessed weekly, up to 24 weeks	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).
Change in depression as measured by the Overall Depression Severity and Impairment Scale	assessed weekly, up to 24 weeks	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.
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale	assessed weekly, up to 24 weeks	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.
Change in anger as measured by the Clinical Anger Scale	assessed weekly, up to 24 weeks	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.
Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire	assessed weekly, up to 24 weeks	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States