Clinical trial NCT04365543: Treatment for Youth (Ages 8 to 16 Years Old) With Misophonia (U-HEAR)
Official title: Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Misophonia
Keywords: misophonia
sensory sensitivity
anxiety
sound
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2020-04-28
Enrollment: 124
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks)
timeFrame: 5 weeks
measure: Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks)
timeFrame: 10 weeks
measure: Severity of symptoms measured by Clinical Global Impression - Severity (Baseline)
timeFrame: Baseline
measure: Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks)
timeFrame: 5 weeks
measure: Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks)
timeFrame: 5 weeks
measure: Overall impairment measured by Child's Global Assessment Scale (Baseline)
timeFrame: Baseline
measure: Overall impairment measured by Child's Global Assessment Scale (5 weeks)
timeFrame: 5 weeks
measure: Overall impairment measured by Child's Global Assessment Scale (10 weeks)
timeFrame: 10 weeks
Secondary outcomes:
measure: Misophonia symptoms as measured by Misophonia Assessment Questionnaire
timeFrame: Baseline
measure: Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
timeFrame: 5 weeks
measure: Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire
timeFrame: 10 weeks
measure: Misophonia symptoms as measured by Misophonia Questionnaire
timeFrame: Baseline
measure: Change in misophonia symptoms as measured by Misophonia Questionnaire
timeFrame: 5 weeks
measure: Change in misophonia symptoms as measured by Misophonia Questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami
state: Florida
city: Saint Petersburg
country: United States
facility: University of Florida Rothman Center
state: Florida
Study officials:
affiliation: University of South Florida
name: Adam Lewin, PhD
role: PRINCIPAL_INVESTIGATOR
References: