Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Despite increasing recognition of misophonia, there are currently no evidence-based treatments to help those who are suffering. Therefore, the primary purpose of this study is to assess the acceptability, feasibility, and preliminary efficacy of a treatment for misophonia. This study will be conducted in two phases. In the Phase 1, participants will receive a treatment the investigators believe can help manage symptoms of misophonia: The Unified Protocol. This treatment uses 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. After treatment, patients will provide feedback about their experience. The investigators will use this feedback to revise the treatment as indicated. In Phase 2, participants will receive the revised treatment and provide feedback on their experience. Throughout treatment in either phase, participants will provide daily and weekly information about their symptoms.

The aims of this study are (1) to explore the acceptability and feasibility of the Unified Protocol for individuals who experience Misophonia and (2) to examine whether this treatment helps reduce symptoms associated with Misophonia.

Study Overview

• Status: Completed
• Conditions: Misophonia
• Intervention / Treatment: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between age 18-65
• Able to read English
• Meet criteria for interfering symptoms of misophonia
• Live in North Carolina

Exclusion Criteria:

• Under age 18 or over age 65
• Current mania
• Current psychotic disorder
• Current anorexia
• Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)

Phase 1 participants cannot also participate in Phase 2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1: 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: Phase 1: 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: Phase 2: Revised 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 revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1.	Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Please see arm/group descriptions
Experimental: Phase 2: Revised 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 revised Unified Protocol (UP). The UP is an emotion-focused treatment designed to teach participants skills to help manage difficult experiences and will be revised based on patient feedback in Phase 1.	Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Please see arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)	The Satisfaction with Therapy and Therapist Scale is a 13-item measure that asks patients about their satisfaction with treatment and with their therapist.	up to 20 weeks
Number of sessions attended	The number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment	up to 20 weeks
Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)	The SMQ is a 16-item measure that asks patients about their use of mindfulness skills .	up to 24 weeks
Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)	The CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment	up to 24 weeks
Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)	The BAQ is a five item measure that assesses use of behavior change skills taught in treatment.	up to 24 weeks
Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)	The ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms	up to 24 weeks
Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)	The BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations	up to 24 weeks
Change in anger as measured by the PANAS Hostility Scale	The PANAS Hostility Scale is a 6 item scale that assesses how often a participant experienced anger in the past week.	assessed weekly, up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who report a change in attentional control as measured by the Digit Span Test	This test assesses a participant's ability to selectively use their attention during a task	up to 20 weeks
Number of patients who report a change in attentional control as measured by the Trail Making Test	This test assesses a participant's ability to selectively use their attention during a task	up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Stroop test	This test assesses a participant's ability to alternate their responses based on instructions.	up to 20 weeks
Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test	This test assesses a participant's ability to alternate their responses based on instructions.	up to 20 weeks
Number of seconds participant engaged in a physiological challenge exercise	Participants will be asked to breathe through a small straw, with the option to stop at any time	up to 20 weeks
Number of seconds participant engaged in a writing task	Participants will be asked to write about emotion-provoking situations, with the option to stop at any time	up to 20 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: M. Zachary Rosenthal, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Misophonia
• Other Study ID Numbers: Pro00106807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No