Clinical trial NCT04612374: Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
Official title: Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Misophonia
Keywords: Misophonia
Treatment
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ
timeFrame: up to 20 weeks
measure: Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)
timeFrame: up to 20 weeks
measure: Number of sessions attended
timeFrame: up to 20 weeks
measure: Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)
timeFrame: up to 24 weeks
measure: Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)
timeFrame: up to 24 weeks
measure: Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)
timeFrame: up to 24 weeks
measure: Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)
timeFrame: up to 24 weeks
measure: Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: up to 24 weeks
measure: Change in misophonia symptoms as assessed by the Misophonia Questionnaire
timeFrame: assessed weekly, up to 24 weeks
measure: Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
timeFrame: assessed weekly, up to 24 weeks
measure: Change in depression as measured by the Overall Depression Severity and Impairment Scale
timeFrame: assessed weekly, up to 24 weeks
measure: Change in anger as measured by the PANAS Hostility Scale
timeFrame: assessed weekly, up to 24 weeks
Secondary outcomes:
measure: Number of patients who report a change in attentional control as measured by the Digit Span Test
timeFrame: up to 20 weeks
measure: Number of patients who report a change in attentional control as measured by the Trail Making Test
timeFrame: up to 20 weeks
measure: Number of patients who report a change in cognitive flexibility as measured by the Stroop test
timeFrame: up to 20 weeks
measure: Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test
timeFrame: up to 20 weeks
measure: Number of seconds participant engaged in a physiological challenge exercise
timeFrame: up to 20 weeks
measure: Number of seconds participant engaged in a writing task
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: M. Zachary Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References: