Misophonia Clinical Trial
— U-HEAROfficial title:
Unified Protocol to Help Emotions and Promote Auditory Relief (U-HEAR).
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.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | December 2022 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program at the University of Miami | Coral Gables | Florida |
United States | University of Florida Rothman Center | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in symptoms measured by Clinical Global Impression - Improvement (5 weeks) | Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 5 weeks of treatment. | 5 weeks | |
Primary | Improvement in symptoms measured by Clinical Global Impression - Improvement (10 weeks) | Clinical Global Impression-Improvement (CGI-I) is a 7-point clinician rated scale of treatment response anchored by 1 (very much improved) and 7 (very much worse). For categorical secondary outcomes, response is defined as a CGI-I rating of 1 or 2 (much improved/very much improved), and remission as CGI-S of 1 to 2. CGI-I will be used to measure symptom improvement after 10 weeks of treatment. | 10 weeks | |
Primary | Severity of symptoms measured by Clinical Global Impression - Severity (Baseline) | Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). Severity will be measured before treatment begins to create a baseline for each participant. | Baseline | |
Primary | Severity of symptoms measured by Clinical Global Impression - Severity (5 weeks) | Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 5 weeks of treatment. | 5 weeks | |
Primary | Severity of symptoms measured by Clinical Global Impression - Severity (10 weeks) | Clinical Global Impression-Severity (CGI-S) is a widely used 7-point clinician rating of severity of psychopathology; raters will be instructed to score based on psychopathology and misophonia symptoms. Severity ratings range from 1 (no illness) to 7 (extremely severe). CGI-S will be used to measure severity after 10 weeks of treatment. | 5 weeks | |
Primary | Overall impairment measured by Child's Global Assessment Scale (Baseline) | Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100. General functioning of the participant will be measured before treatment begins to create a baseline for each subject. | Baseline | |
Primary | Overall impairment measured by Child's Global Assessment Scale (5 weeks) | Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 5 weeks of treatment. | 5 weeks | |
Primary | Overall impairment measured by Child's Global Assessment Scale (10 weeks) | Clinician rated measure of general functioning including impairment to capture functioning/impairment independent of diagnoses. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100). CGAS will be used to measure general functioning after 10 weeks of treatment. | 10 weeks | |
Secondary | Misophonia symptoms as measured by Misophonia Assessment Questionnaire | Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds. | Baseline | |
Secondary | Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire | Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds. | 5 weeks | |
Secondary | Change in misophonia symptoms as measured by Misophonia Assessment Questionnaire | Misophonia Assessment Questionnaire (MAQ) is a 21 item, youth self-report, and parent-report questionnaire assessing severity and side effects of the youth's misophonia symptoms and reactions to misophonic sounds. | 10 weeks | |
Secondary | Misophonia symptoms as measured by Misophonia Questionnaire | The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score. | Baseline | |
Secondary | Change in misophonia symptoms as measured by Misophonia Questionnaire | The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score. | 5 weeks | |
Secondary | Change in misophonia symptoms as measured by Misophonia Questionnaire | The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities). The youth self-report (for those 10 and older) and parent report will serve as both a measure of symptoms of misophonia and allow for calculation of severity score. | 10 weeks |
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