Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia

NCT ID: NCT04612374

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2022-08-04

Brief Summary

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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.

Detailed Description

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Conditions

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Misophonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1: Unified Protocol, 2 week baseline

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.

Group Type EXPERIMENTAL

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

Please see arm/group descriptions

Phase 1: Experimental: Unified Protocol, 4 week baseline

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.

Group Type EXPERIMENTAL

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

Please see arm/group descriptions

Phase 2: Revised Unified Protocol, 2 week baseline

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.

Group Type EXPERIMENTAL

Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

Please see arm/group descriptions

Phase 2: Revised Unified Protocol, 4 week baseline

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.

Group Type EXPERIMENTAL

Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

Please see arm/group descriptions

Interventions

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Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Please see arm/group descriptions

Intervention Type BEHAVIORAL

Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Please see arm/group descriptions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. Zachary Rosenthal, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00106807

Identifier Type: -

Identifier Source: org_study_id

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