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Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

N/A
Waitlist Available
Led By M. Zachary Rosenthal, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in anger as measured by the PANAS Hostility Scale
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
Change in depression as measured by the Overall Depression Severity and Impairment Scale
+9 more
Secondary study objectives
Number of patients who report a change in attentional control as measured by the Digit Span Test
Number of patients who report a change in attentional control as measured by the Trail Making Test
Number of patients who report a change in cognitive flexibility as measured by the Stroop test
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: Revised Unified Protocol, 4 week baselineExperimental Treatment1 Intervention
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.
Group II: Phase 2: Revised Unified Protocol, 2 week baselineExperimental Treatment1 Intervention
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.
Group III: Phase 1: Unified Protocol, 2 week baselineExperimental Treatment1 Intervention
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.
Group IV: Phase 1: Experimental: Unified Protocol, 4 week baselineExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
2020
N/A
~110
Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
2020
N/A
~20

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,887 Total Patients Enrolled
3 Trials studying Misophonia
131 Patients Enrolled for Misophonia
M. Zachary Rosenthal, PhDPrincipal InvestigatorDuke University
~4 spots leftby Dec 2025