Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Not Applicable

Completed

• Conditions: Misophonia
• Interventions: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

• Registration Number: NCT04612374
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Study Start: 2020-12-21
• Status Verified: 2022-02
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: 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.
Phase 2: Revised Unified Protocol, 2 week baseline	Revised 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 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.
Phase 2: Revised Unified Protocol, 4 week baseline	Revised 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 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.
Phase 1: Experimental: 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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