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Exploring Two Treatments for Misophonia

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ClinicalTrials.gov Identifier: NCT04198597
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Misophonia Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Behavioral: Process-based Cognitive Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Two CBT-based Treatments as Interventions for Emotion Dysregulation in Misophonia
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unified Protocol, 2 week baseline
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.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Please see arm/group descriptions

Experimental: Unified Protocol, 4 week baseline
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.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Please see arm/group descriptions

Experimental: Process-based treatment, 2 week baseline
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.
Behavioral: Process-based Cognitive Behavioral Therapy
Please see arm/group descriptions

Experimental: Process-based treatment, 4 week baseline
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.
Behavioral: Process-based Cognitive Behavioral Therapy
Please see arm/group descriptions




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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

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

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): NCT04198597


Contacts
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Contact: Clair Robbins, Ph.D. 919-684-9486 clair.robbins@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: Clair Robbins       clair.robbins@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Zachary Rosenthal, Ph.D. Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04198597    
Other Study ID Numbers: Pro00103962
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No