Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Misophonia Clinical Trial

Official title:

Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612374
• Other study ID #: Pro00106807
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: August 4, 2022

Study information

• Verified date: February 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Misophonia

Intervention

Behavioral:
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Please see arm/group descriptions
• Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
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)	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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