Clinical trial NCT06493825: Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia
Official title: Effects of Immersive Virtual Reality Mindfulness Application on Quality of Life, Anxiety and Depression Symptoms in Children With Severe Tinnitus and Misophonia - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Misophonia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

The primary outcome measures are the changes ot the pre-entry and post-entry scores of the 5 validated instruments at 2 weeks post-entry. In the experimental group, dose response will be measured between the 2- and 4-week results.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: 2 weeks
measure: Amsterdam Misophonia Scale (A-MIS-S)
timeFrame: 2 weeks
measure: Pediatric Quality of Life PedQL)
timeFrame: 2 weeks
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: 2 weeks
measure: Short Mood and Feelings Questionnaire (SMFQ)
timeFrame: 2 weeks
measure: Tinnitus Functional Index (TFI)
timeFrame: 4 weeka
measure: Amsterdam Misophonia Scale (A-MIS-S)
timeFrame: 4 weeks
measure: Pediatric Quality of Life PedQL)
timeFrame: 4 weeks
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: 4 weeks
measure: Short Mood and Feelings Questionnaire (SMFQ)
timeFrame: 4 weeks
Secondary outcomes:
measure: Satisfaction, acceptability and feasibility survey
timeFrame: 2 weeks
measure: Satisfaction, acceptability and feasibility survey
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: