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Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04612374
Enrollment
18
Registered
2020-11-03
Start date
2020-12-21
Completion date
2022-08-04
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Misophonia

Keywords

Misophonia, Treatment

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.

Interventions

BEHAVIORALRevised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Please see arm/group descriptions

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anger as measured by the PANAS Hostility Scaleassessed weekly, up to 24 weeksThe PANAS Hostility Scale is a 6 item scale that assesses how often a participant experienced anger in the past week.
Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)up to 24 weeksThe BAQ is a five item measure that assesses use of behavior change skills taught in treatment.
Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)up to 24 weeksThe ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms
Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)up to 24 weeksThe BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations
Change in misophonia symptoms as assessed by the Misophonia Questionnaireassessed weekly, up to 24 weeksThe 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 anxiety as measured by the Overall Anxiety Severity and Impairment Scaleassessed weekly, up to 24 weeksThe 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.
Change in depression as measured by the Overall Depression Severity and Impairment Scaleassessed weekly, up to 24 weeksThe 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.
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQup to 20 weeksThe CEQ is a 6-item measure that asks patients about their perceptions of treatment.
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 weeksThe 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 sessions attendedup to 20 weeksThe number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment
Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)up to 24 weeksThe SMQ is a 16-item measure that asks patients about their use of mindfulness skills .
Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)up to 24 weeksThe CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment

Secondary

MeasureTime frameDescription
Number of patients who report a change in attentional control as measured by the Trail Making Testup to 20 weeksThis test assesses a participant's ability to selectively use their attention during a task
Number of patients who report a change in cognitive flexibility as measured by the Stroop testup to 20 weeksThis 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 Testup to 20 weeksThis test assesses a participant's ability to alternate their responses based on instructions.
Number of seconds participant engaged in a physiological challenge exerciseup to 20 weeksParticipants will be asked to breathe through a small straw, with the option to stop at any time
Number of seconds participant engaged in a writing taskup to 20 weeksParticipants will be asked to write about emotion-provoking situations, with the option to stop at any time
Number of patients who report a change in attentional control as measured by the Digit Span Testup to 20 weeksThis test assesses a participant's ability to selectively use their attention during a task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026