Exploring Two Treatments for Misophonia

NCT04198597 | Completed

• 1 other identifier: Pro00103962
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use 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. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help reduce symptoms associated with Misophonia.

Conditions

Misophonia

Outcome Measures

Primary Outcomes (2)

• 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)

  This form has two questions that assess how satisfied patients were with treatment and how acceptable treatment was to them. The remaining three items are open ended questions that allow patients to provide narrative feedback about their experience in treatment.

  up to 20 weeks

Secondary Outcomes (5)

• Change in misophonia symptoms as assessed by the Misophonia Questionnaire

  assessed weekly, up to 24 weeks

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

  assessed weekly, up to 24 weeks

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

  assessed weekly, up to 24 weeks

• Change in anger as measured by the Clinical Anger Scale

  assessed weekly, up to 24 weeks

• Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire

  assessed weekly, up to 24 weeks

Study Arms (4)

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

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

Process-based treatment, 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized.

Behavioral: Process-based Cognitive Behavioral Therapy

Process-based treatment, 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 process-based therapy. Process-based therapy is a flexible therapy designed to teach skills that help people manage difficult experiences. Patient and therapist work together to determine which skills will be utilized.

Behavioral: Process-based Cognitive Behavioral Therapy

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

Please see arm/group descriptions

Unified Protocol, 2 week baseline; Unified Protocol, 4 week baseline

Process-based Cognitive Behavioral Therapy BEHAVIORAL

Please see arm/group descriptions

Process-based treatment, 2 week baseline; Process-based treatment, 4 week baseline

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Under age 18
• Current mania
• Current psychotic disorder
• Current anorexia
• Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
• Has received any treatment specifically for misophonia in the past year

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

• Zachary Rosenthal, Ph.D.

  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: December 12, 2019
• First Posted: December 13, 2019
• Study Start: September 11, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: November 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)