Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorUniversity of Colorado, Denver
About this trial
Children with "bothersome" tinnitus and misophonia have elevated anxiety and depression symptoms. The mainstay therapy for adults and children with these disorders is cognitive behavioral therapy (CBT). CBT resources are expensive and scarce for the pediatric population. Immersive virtual reality (IVR) has been shown in the adult population to be a proxy for CBT for several mental health disorders. There is sufficient published evidence that IVR is useful in treating adults with anxiety and depression disorders. However, the evidence in children in treating either anxiety and depression symptoms or disorder is scant. Our group views IVR application as a promising medical device to decrease anxiety and depression scores in children with tinnitus and misophonia disorders.
This is a randomized placebo control (single-blinded to the study subjects) study in which there will be a 2:1 ratio between the experimental and placebo subjects, receiving either active IVR or placebo exposure. A total of 30 subjects with 20 experimental (10 tinnitus, 10 misophonia subjects) and 10 placebo (5 tinnitus and 5 misophonia subjects) will enroll in this randomized clinical trial. Assessment of change of quality of life, anxiety and depression symptoms will be based on 5 validated instruments.
The 5 validated instruments are: Tinnitus Functional Index (TFI), Amsterdam Misophonia Scale (A-MIS-S), Pediatric Quality of Life PEDQL), Screen for Child Anxiety Related Emotional Disorders (SCARED) and Short Mood and Feelings Questionnaire (SMFQ).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children between the ages of 10 to 18 years
All genders and ethnicities
Patients who meet criteria for "severe" symptoms of tinnitus and misophonia as scored by TIF and A-MISO-S
Disqualifiers
Severe developmental delay as not to understand verbal instructions necessary to complete the VR application/sham exposure.
Severe visual impairment (refractive disorders are acceptable)
Patients with unilateral or bilateral hearing loss of any type.
History of seizure disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Aurora Mindfulness app versus sham
Other interventionIt would either immersive virtual reality exposure for the experimental group or non-immersive virtual reality exposure for the placebo group.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: PlaceboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tinnitus Functional Index (TFI)
TFI measures the severity of tinnitus symptoms across several domains with a score range 0 to 90. The higher the score, the more dysfunction a subject is affected by tinnitus.
Time frame
2 weeks2
Amsterdam Misophonia Scale (A-MIS-S)
A-MIS-S measures the severity of misophonia symptoms across several domains with a score range of 0-24. The higher the score, the more dysfunction a subject is affected by misophonia.
Time frame
2 weeks3
Pediatric Quality of Life PedQL)
PedQL measures health-related quality of life of children with a range of 0 -100. The higher the score, the worse the health-related quality of life is.
Time frame
2 weeks4
Screen for Child Anxiety Related Emotional Disorders (SCARED)
SCARED screens for anxiety disorder in children and it ranges from 0-82. The higher the score, the higher the likelihood a child might have an anxiety disorder.
Time frame
2 weeksSecondary outcomes
1
Satisfaction, acceptability and feasibility survey
The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.
Time frame
2 weeks2
Satisfaction, acceptability and feasibility survey
The survey is in a 5-point Likert scale format with a range of very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov