Mindfulness Application Effects on Mental Health Symptoms in Children With Severe Tinnitus and Misophonia

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Misophonia; Tinnitus

Treatments: Other: Aurora Mindfulness app versus sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06493825

24-0389

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental

Experimental group

Description:

Subjects will undergo 4 weeks of immersive virtual reality exposure using the Aurora Mindfulness app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline, 2-week and 4-week measurement of symptoms using 5 validated instruments.

Treatment:

Other: Aurora Mindfulness app versus sham

Placebo

Sham Comparator group

Description:

Subjects will undergo 2 weeks of immersive virtual reality exposure using the Aurora Mindfulness sham app (Invincikids) delivered using a Meta Quest 2 headset at the frequency of 10 minutes per session, 5 days out of a 7-day week. Subjects will undergo baseline and 2-week measurement of symptoms using 5 validated instruments.

Treatment:

Other: Aurora Mindfulness app versus sham