Treatment for Youth (Ages 8 to 16 Years Old) With Misophonia (U-HEAR)

NCT ID: NCT04365543

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2022-12-31

Brief Summary

If someone is really sensitive to certain noises and sounds, they might have misophonia. U-HEAR is a study created to find out what helps kids and teens with misophonia. There are two treatments being tested in this study. The treatment your child receives will be determined at random. There will be a Two-Thirds (2/3rds or 66%) chance your child will receive a treatment called the Unified Protocol for Children and Adolescents (UP-C/A) that has been modified to meet the needs for youth with misophonia. There is a One-Third (1/3rd or 33%) chance your child will receive a treatment called Psychoeducation and Relaxation. All participants will get ten free treatment sessions. Each session will last one hour and happen once a week. The aim of the study is to evaluate the feasibility and preliminary efficacy of the UP-C/A for youth with misophonia.

Detailed Description

Misophonia is a condition characterized by intense affective and/or physical responses to auditory triggers. Negative affective states, including significant distress and avoidance are characteristic of misophonia. These negative emotional responses to trigger sounds, which result in behavioral problems and impairment, may be the primary targets for effective psychosocial intervention for misophonia. Transdiagnostic treatment approaches address clinically-significant distress through the use of evidence-based, cognitive-behavioral techniques (e.g., mindful awareness, problem-solving, and opposite action strategies) that allow for flexible and personalized treatment of core dysfunctions that cut across emotional disorders and lead to on-going impairment. This type of evidence-based, transdiagnostic approach includes skills applicable for problems observed frequently in misophonia including adaptability, problem solving, emotional (arousal) dysregulation and poor distress tolerance. The hypothesized mechanism of change of these core-dysfunction focused treatments is increased tolerance of distress in response to strong or intense emotion states. A secondary target is the reduction of maladaptive emotional behaviors (e.g., avoidance, aggression, escape) that may reinforce distress over time. To that end, this proposal aims to evaluate the feasibility and preliminary efficacy of the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia. We will compare UP-C/A in a 2:1 ratio against a comparison condition (PRT: psychoeducation plus relaxation training), a behavioral approach that represents usual treatment in the community and has been utilized in clinical trials (35% response rate).

Conditions

Misophonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UP-C/A for Misophonia

The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) are manualized treatments for treating emotional disorders in youth. We have modified the UP-C/A to meet the needs for youth with misophonia.

Group Type: EXPERIMENTAL

Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia

Intervention Type: BEHAVIORAL

Please see arm/group descriptions

Psychoeducation and Relaxation Therapy

Psychoeducation and Relaxation Therapy (PRT) is a treatment that educates the child on misophonia and provides training in relaxation skills and tools for calming panic, anxiety and anger feelings.

Group Type: EXPERIMENTAL

Psychoeducation and Relaxation Therapy (PRT)

Intervention Type: BEHAVIORAL

Please see arm/group descriptions

Interventions

Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia

Please see arm/group descriptions

Intervention Type: BEHAVIORAL

Psychoeducation and Relaxation Therapy (PRT)

Please see arm/group descriptions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The child meets criteria for misophonia
• The child is currently living with their family/guardian(s)
• The child is between 8 and 16 years old
• Parent/legal guardian and child are able to read and speak English without a translator
• Parent/legal guardian is able to attend weekly sessions and all assessments
• If the child is on a psychotropic medication, they will need to be on a stable dose for 4 weeks prior to assessment (2 weeks for stimulant medication)

Exclusion Criteria

• The child has received prior UP-C/A treatment
• The child is acutely suicidal
• The child has a current diagnosis of psychosis, bipolar disorder, intellectual disability, alcohol/substance dependence, or eating disorder

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Adam Lewin

Associate Professor and Interim Division Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Lewin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami

Coral Gables, Florida, United States

Site Status: RECRUITING

University of Florida Rothman Center

St. Petersburg, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly Kudryk, BA

Role: CONTACT

kellykudryk@miami.edu

813-586-1630

Jane Mutch, PhD

Role: CONTACT

rothmanctr@usf.edu

727-767-8230

Facility Contacts

Ashley Karlovich, BA

Role: primary

anxietylab@psy.miami.edu

305-284-9852 ext. 1

Kelly Kudryk, BA

Role: primary

kellykudryk@usf.edu

813-586-1630

Other Identifiers

Pro#00042498

Identifier Type: -

Identifier Source: org_study_id