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

University of South Florida

Status: Unknown

Conditions: Misophonia

Treatments: Behavioral: Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia; Behavioral: Psychoeducation and Relaxation Therapy (PRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04365543

Pro#00042498

Details and patient eligibility

About

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.

Full 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).

Enrollment: 124 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

UP-C/A for Misophonia

Experimental group

Description:

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.

Treatment:

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

Psychoeducation and Relaxation Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Psychoeducation and Relaxation Therapy (PRT)