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Completed

NCT Number: NCT04198597

Exploring Two Treatments for Misophonia

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.

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Key information

Conditions

Misophonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Behavioral

Please see arm/group descriptions

Process-based Cognitive Behavioral Therapy

Behavioral

Please see arm/group descriptions

Primary outcomes

  1. Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ)

    Time frame: up to 20 weeks

    The CEQ is a 6-item measure that asks patients about their perceptions of treatment.

  2. Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)

    Time frame: 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.

Secondary outcomes

  1. Change in misophonia symptoms as assessed by the Misophonia Questionnaire

    Time frame: 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).

  2. Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale

    Time frame: 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.

  3. Change in depression as measured by the Overall Depression Severity and Impairment Scale

    Time frame: 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.

  4. Change in anger as measured by the Clinical Anger Scale

    Time frame: 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.

  5. Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2019
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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