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Completed

NCT Number: NCT04612374

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.

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Key information

Conditions

Misophonia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Behavioral

Please see arm/group descriptions

Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Behavioral

Please see arm/group descriptions

Primary outcomes

  1. Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ

    Time frame: up to 20 weeks

    The CEQ is a 6-item measure that asks patients about their perceptions of treatment.

  2. Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)

    Time frame: 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.

  3. Number of sessions attended

    Time frame: up to 20 weeks

    The number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment

  4. Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)

    Time frame: up to 24 weeks

    The SMQ is a 16-item measure that asks patients about their use of mindfulness skills .

  5. Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)

    Time frame: up to 24 weeks

    The CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment

  6. Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)

    Time frame: up to 24 weeks

    The BAQ is a five item measure that assesses use of behavior change skills taught in treatment.

  7. Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)

    Time frame: up to 24 weeks

    The ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms

  8. Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)

    Time frame: up to 24 weeks

    The BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations

  9. Change in misophonia symptoms as assessed by the Misophonia Questionnaire

    Time frame: 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).

  10. Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale

    Time frame: 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.

  11. Change in depression as measured by the Overall Depression Severity and Impairment Scale

    Time frame: 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.

  12. Change in anger as measured by the PANAS Hostility Scale

    Time frame: 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.

Secondary outcomes

  1. Number of patients who report a change in attentional control as measured by the Digit Span Test

    Time frame: up to 20 weeks

    This test assesses a participant's ability to selectively use their attention during a task

  2. Number of patients who report a change in attentional control as measured by the Trail Making Test

    Time frame: up to 20 weeks

    This test assesses a participant's ability to selectively use their attention during a task

  3. Number of patients who report a change in cognitive flexibility as measured by the Stroop test

    Time frame: up to 20 weeks

    This test assesses a participant's ability to alternate their responses based on instructions.

  4. Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test

    Time frame: up to 20 weeks

    This test assesses a participant's ability to alternate their responses based on instructions.

  5. Number of seconds participant engaged in a physiological challenge exercise

    Time frame: up to 20 weeks

    Participants will be asked to breathe through a small straw, with the option to stop at any time

  6. Number of seconds participant engaged in a writing task

    Time frame: up to 20 weeks

    Participants will be asked to write about emotion-provoking situations, with the option to stop at any time

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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