Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Phase: NA
Conditions: Anxiety, Obsessive-Compulsive Disorder
Sponsor: Minnesota HealthSolutions

Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for 
Anxiety and Obsessive Compulsive Disorders 
NCT 03636022 
Date: 5/15/2024 
 
 
 
 
 

Study Protocol  
Children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and 
a parent will be recruited to test the VR system with a randomized controlled mixed methods 
study. Participants will be identified by through a Pediatric Anxiety Disorders Clinic using 
purposive sampling methods. All patients complete a standardized diagnostic assessment 
(including the MINI KIDS and Spence Child Anxiety Scales, Parent & Child report and begin 
treatment with psychoeducation on parent-coached exposure therapy for anxiety and OCD, 
create a treatment plan (i.e., fear hierarchy), and proceed to treatment sessions focused on 
completion of exposures. Participants will be recruited after their initial assessment and will 
begin the study in the early stages of treatment after completing psychoeducation and treatment 
planning.  
 
Participants will be randomly assigned to home exposure practice with or without the VR 
system, i.e., intervention or control, respectively. All participants in the study will participate in an 
introductory session in which they complete two exposures related to content from their fear 
ladder, one with the VR system and an analogous imaginal exposure. Each family will receive 
instructions for how to use the exposure tracking form to record exposures during home 
practice. Participants will then be assigned one week of daily exposure homework for both the 
intervention and control conditions. Patients randomized to the intervention condition will take 
home the VR system for homework completion and participants assigned to control will be 
instructed to complete imaginal exposures. One week after the introductory session, all 
participants will return for a session in which they complete both types of exposure. They will 
also be assigned third generalization exposure, i.e., an exposure related to the baseline 
exposure that is higher on the fear ladder, to complete at their next anxiety clinic treatment 
session. Subjective Units of Distress (SUDS) ratings for each type of exposure will be recorded 
on paper with the exposure tracking form. During the follow up session, an independent 
interviewer will observe participants’ engagement during exposures and will interview 
participants and their parents about their experience with both types of exposure.  
 
Study Population 
Potential participants will be ages 7 to 17 years old; have a diagnosis of CAD (i.e., generalized 
anxiety disorder, separation anxiety disorder, specific phobia, panic disorder with or without 
agoraphobia) or OCD; and have at least one fear fitting exposures covered by the VR system. 
Qualifying diagnoses will be based on standardized assessments in the Clinic (MiniKIDS). 
Potential participants will be excluded if they have a high likelihood of being lost to follow-up or 
contact; are unable to provide good data; have significant comorbidity that would interfere with 
participation (e.g., uncontrolled oppositional defiant disorder) or are at heightened risk of self-
harm (e.g., presence of active suicidal ideation reported on clinical interview or endorsement on 
a self-report measures, such as the PHQ-9M). Research assistants (RA) will approach eligible 
patients and describe the study. The RA will then obtain written informed consent from the 
parents and written informed assent from the child. Every effort will be made to enroll subjects in 
proportion to the gender and racial/ethnic demographics of the treatment population. 
 
Study Protocol 
Following recruitment and consent and assent, participants will be randomly assigned to the 
intervention or control condition. Then, participants will complete a baseline study session with 
study staff at the Clinic. At this session, the staff member will follow a standardized protocol to 
instruct all participants and their parents on how to use the exposure tracking form to 
electronically record exposure practice. Because all study participants will have started 
treatment in the Clinic, including orientation to parent-coached exposure, participating families 

will be familiar with parent-coached exposure procedures. Standard Clinic treatment includes 
parent-coached exposure in and between sessions. For the study baseline session, a Clinic 
psychologist/therapist will follow the standardized protocol to guide all participants through 
planning two exposures related to content from their personalized fear ladder, one with the VR 
system and an analogous imaginal exposure (order randomized). Parent-child dyads will 
complete these exposures in session with study staff present (in most cases, the research 
coordinator). During each exposure, the participant will record his or her anxiety using a 0 to 10 
SUDS rating scale, the standard procedure during clinical care and between-session exposures. 
For the VR exposure, the staff member will ask the participant to follow instructions presented 
by the VR program. The conventional exposure will follow common clinical practice for imaginal 
exposures; specifically, the participant will write a story about their fears coming true and then 
read the story aloud. In each condition, the staff member will encourage the participant to repeat 
the exposure until anxiety ratings are reduced by 50%. Based on clinical experience and 
confirmed during earlier research, it is anticipated that participants’ anxiety will be manageable 
throughout the exposure and will have habituated by the end of the exercise. Each of the study 
sessions will be approximately 90 minutes.  In the unlikely event of difficulties during a study 
session, and in accordance with the safety monitoring plan, the lead psychologists will be 
available to evaluate the participant, address emotional distress, and arrange appropriate care. 
Throughout the course of the study (i.e., between study sessions), participants will have access 
to the lead psychologists as well as the supports of typical clinical care including the treating 
therapist, or a covering clinician through the Clinic Division of Child Psychiatry and Psychology 
will be available for research participants 24 hours a day, 7 days a week. The exposure activity 
and SUD ratings for each exposure will be recorded on paper with the exposure tracking form. 
Each participant will be asked to wear a sensor on their wrist during the in-office exposures.  
These sensors are similar to an activity tracker. The sensors will measure real-time 
physiological data (i.e. heart rate, acceleration, body temperature, etc).  This information will 
allow the study team to note changes with the patient as they participate in the exposures.  
It will also provide valuable data that can be analyzed at the end of the study.  These 
sensors do not collect any patient health information. The sensors will either Empatica E4 
but in the event the study team cannot get the Empatica 4, they will use the Elite HRB 
CorSense. 
 
Participants will then be assigned one week of daily exposure homework with or without VR, 
depending on condition, using a paper exposure tracking form to record each exposure and 
SUDS. Patients randomized to intervention will take home the VR system for homework 
completion, and participants assigned to control will not take the VR system home and will be 
instructed to complete imaginal exposures. Participants will be asked to record each exposure, 
even if it is not related to the fear addressed with the baseline exposures, in order to capture all 
exposures completed during the homework period.  
 
One week after the baseline session, all participants will return for a follow up session in which 
they complete both types of exposure (order randomized) and will receive an assignment to 
complete in their next Clinic therapy appointment a third generalization exposure, i.e., an 
exposure related to the baseline exposure that is higher on the fear ladder for the targeted fear, 
following procedures analogous to the baseline session. During the follow up session, staff from 
Clinic Health Care Policy & Research (“the interviewer”) experienced in qualitative data analysis 
and not involved with the patients’ medical care or development of the prototype system will 
observe, record, and code participants’ engagement in the exposures and will interview 
participants about their experience with both types of exposure and then will ask for 
observations and opinions from the parent. A psychologist from the Clinic Health Care Policy & 
Research will work with the two lead child psychologists to identify questions and topics for a 

semi-structured interview guide. The guide will be pilot-tested to ensure that questions and 
follow-up probes are easily comprehended and delivered in a sensitive manner. The semi-
structured guide will follow guidelines for minimizing bias and increasing the reliability and 
validity of interview data[64,65]. All interviews will be audio-recorded. 
 
During the participants’ next therapy session, they will complete the assigned generalization 
exposure. SUDS ratings will be recorded for that exposure using the paper exposure tracking 
form, and participants will wear a sensor to obtain biometrics during the exposure. 
 
Thus, study participation will include the two study sessions, completion and recording of 
exposures for one week between study sessions, and completion of a study-assigned exposure 
in a subsequent Clinic therapy session. Participation consent and assent will include agreement 
for clinically gathered assessments to be used for the study (i.e., initial structured interview, 
symptom rating scales completed at initial evaluation and clinic treatment follow up, number of 
treatment sessions attended, length of treatment). Study participants will continue with any 
treatment as usual during study participation. 
Participant Recruitment & Participation Flow 
 
Initial Clinic visit 
Baseline Study Visit 
1 week out-of-
session exposure 
Follow up Study Visit 
Next Therapy 
Session 
End of treatment 
assessments 
Complete 
diagnostic 
interview & 
questionnaires as 
part of usual 
clinic procedures; 
If the patient 
meets study 
criteria, the Clinic 
psychologist/ther
apist will invite 
the patient and 
parent to 
participate 
Informed 
Consent/Assent. 
2 Baseline 
exposures. 
Participant will wear 
a sensor to obtain 
biometrics and 
SUDS ratings will be 
collected. 
Participants will 
be instructed to 
practice daily 
either the VR 
exposure or 
imaginal 
exposure, 
depending on 
study condition, 
and to record 
exposures using 
the exposure 
tracking form 
Repeat 2 baseline 
exposures. 
Participant will wear a 
sensor to obtain 
biometrics and SUDS 
ratings will be 
collected. 
Participants assigned 
generalization 
exposure to complete 
in next therapy 
session 
 
Qualitative interview 
and observation. 
Complete the Spence 
Child Anxiety Scales 
and the Child 
Sheehan Disability 
Scale. 
Participant will wear a 
sensor to obtain 
biometrics. 
 
Participant will 
complete the 
assigned 
generalization 
exposure during 
therapy session 
following the 
Follow up Study 
Visit 
 
Participant will 
wear a sensor to 
obtain 
biometrics and 
SUDS ratings 
will be collected. 
 
Participants 
complete 
questionnaires as 
part of usual 
clinic procedures. 
Study staff 
records data 
related to 
treatment length 
and # treatment 
sessions. 
Post-Treatment 
from Clinic 
 
 
Participants continue with any treatments as usual, including treatment through Clinic 
 
 
 
 
 
 

Statistical Analysis Plan 
 
Analysis Plan 
The primary outcomes of the study are: (1) difference in maximum SUDS ratings during time 1 
exposures between VR and conventional, 2) difference in number of exposures completed to 
assigned item (as well as overall) between conditions; 3) difference in maximum SUDS rating in 
cross over exposure between conditions during time 2; and 4) difference in maximum SUDS 
rating in generalization exposure between conditions during time 2. We will also conduct 
exploratory analyses to see if decrease in anxiety symptoms, as measured by the Spence Child 
Anxiety Scales, Child and Parent reports, and improvement in functional impairment, as 
measured by the Child Sheehan Disability Scale, differ between groups. 
 
Quantitative analysis: Descriptive and inferential statistics will be used, including means, 
standard deviations, medians, ranges, frequency distributions, t-tests, and Analyses of Variance 
(ANOVAs). Specifically: a) differences in maximum SUDS ratings during VR and traditional 
exposures during time 1 session will be examined using a paired-samples t-tests, b) change 
over time in the peak anxiety ratings for each modality (VR vs. imaginal) will be examined using 
Repeated Measures ANOVAs with VR status as the between subjects variable and change in 
anxiety rating (T1 to T2 difference in maximal SUDS for VR vs.T1 to T2 difference in maximal 
SUDS for imaginal) being the within subjects variable, c) differences between homework 
exposure conditions, on maximal anxiety in the generalization exposure at time 2 controlling for 
time 1 maximal SUDS averaged across exposure conditions will be examined using Analyses of 
Covariance (ANCOVA) with homework condition as the between subjects variable and number 
of completed exposures and average maximum anxiety across the two time 1 exposures as the 
covariates; and d) ANCOVA will be used to compare average number of homework exposures 
completed to target item (as well as overall exposures) during the study time frame between the 
conditions (i.e. VR vs. imaginal) controlling for patient characteristics (age, sex, diagnoses). 
Exploratory analyses will compare change in anxiety symptoms from time 1 to time 2 between 
conditions, controlling for patient characteristics, and examining number of completed 
exposures as a mediator of change.  
 
Qualitative analysis: We will conduct semi-structured interviews during the second study 
session with both the child and parent. These interviews will collect data on the participant’s 
experiences, opinions, perceived benefits and barriers, and engagement with the system. An 
inductive coding approach will be used to condense these data and to identify themes. The 
Division of Health Care Policy & Research employs approximately 386 allied health and 62 
doctoral level staff including survey research, qualitative research, statistical support, and chart 
review personnel as well as a dedicated publication specialist on staff.  HCPR has created a 
core of behavioral scientists with expertise in qualitative research.  They psychologist from 
HCPR has experience in qualitative research in the evaluation of mental health interventions. 
Analysts with experience in qualitative data analysis will code interviews using methods of 
content analysis, i.e., systematic process of sorting and coding information based on themes. 
QSR's NVivo 2010 qualitative data software analysis program will be used to facilitate data 
coding and sorting.