Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

NCT04612374 | Completed

• 1 other identifier: Pro00106807
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Misophonia

Keywords

Misophonia; Treatment

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

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

  up to 20 weeks

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

  up to 20 weeks

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

  up to 20 weeks

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

  up to 20 weeks

• Number of seconds participant engaged in a physiological challenge exercise

  up to 20 weeks

Study Arms (4)

Phase 1: Unified Protocol, 2 week baseline

EXPERIMENTAL

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.

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Phase 1: Experimental: Unified Protocol, 4 week baseline

EXPERIMENTAL

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.

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Phase 2: Revised Unified Protocol, 2 week baseline

EXPERIMENTAL

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.

Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Phase 2: Revised Unified Protocol, 4 week baseline

EXPERIMENTAL

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.

Behavioral: Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

Please see arm/group descriptions

Phase 1: Experimental: Unified Protocol, 4 week baseline; Phase 1: Unified Protocol, 2 week baseline

Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

Please see arm/group descriptions

Phase 2: Revised Unified Protocol, 2 week baseline; Phase 2: Revised Unified Protocol, 4 week baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

misophonia

Study Officials

• M. Zachary Rosenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: December 21, 2020
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)