NCT04365543

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

Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia	Please see arm/group descriptions
BEHAVIORAL	Psychoeducation and Relaxation Therapy (PRT)	Please see arm/group descriptions

Timeline

• Start date: 2020-04-08
• Primary completion: 2022-03-01
• Completion: 2022-12-01
• First posted: 2020-04-28
• Last updated: 2020-04-28

Locations

2 sites across 1 country: United States