Anxiety, Obsessive-Compulsive Disorder
Conditions
Keywords
Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy, Specific Phobia, Children
Brief summary
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder. The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.
Detailed description
Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and a parent will be recruited to test the Phase II VR system with a randomized controlled mixed methods study. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC). 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 participants complete two exposures related to content from their fear ladder, one with the VR system and analogous imaginal exposure. Each family will receive instructions for how to use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice. Participants will then be assigned one week of daily exposure homework for the intervention and control conditions. Participants 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 participants complete both types of exposure. Participants will also be assigned to a 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 sessions. SUDS ratings for each type of exposure will be recorded electronically via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer will observe participants' engagement during exposure and will interview participants and their parents about their experience with both types of exposure.
Interventions
OTHERVR System
Use of virtual reality to deliver exposure therapy
OTHERControl
Use of conventional delivery of exposure therapy
Sponsors
Mayo Clinic
Minnesota HealthSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 7 to 17 2. Primary diagnosis of an anxiety disorder or obsessive compulsive disorder.
Exclusion criteria
1. History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder. 2. Current sucidality or recent suicidal behavior. 3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties. 4. Starting or changing the dosage of psychiatric medications in the last 2 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 | Baseline and End of Session I, 2 hours | The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure. |
| Maximum SUDS Rating During Crossover Exposure | 2 hours | Crossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group. The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homework Engagement | 1 week | Number of homework exposures completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VR System Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy | 25 |
| Control Condition Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy | 20 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | VR System | Control Condition | Total |
|---|---|---|---|
| Age, Continuous | 13.3 years STANDARD_DEVIATION 2.6 | 13.1 years STANDARD_DEVIATION 3 | 13.2 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 22 Participants | 18 Participants | 40 Participants |
| Region of Enrollment United States | 25 participants | 20 participants | 45 participants |
| Sex/Gender, Customized Gender at Birth Female | 21 Participants | 17 Participants | 38 Participants |
| Sex/Gender, Customized Gender at Birth Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 20 |
| other Total, other adverse events | 0 / 25 | 0 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 20 |
Outcome results
Primary
Maximum SUDS Rating During Crossover Exposure
Crossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group. The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR System | Maximum SUDS Rating During Crossover Exposure | 2.1 units on a scale | Standard Deviation 2.3 |
| Control Condition | Maximum SUDS Rating During Crossover Exposure | 2.5 units on a scale | Standard Deviation 1.8 |
Primary
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1
The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.
Time frame: Baseline and End of Session I, 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR System | Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 | -3.7 units on a scale | Standard Deviation 2 |
| Control Condition | Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 | -3.6 units on a scale | Standard Deviation 1.9 |
Secondary
Homework Engagement
Number of homework exposures completed.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR System | Homework Engagement | 5.4 homework exposures completed | Standard Deviation 1.5 |
| Control Condition | Homework Engagement | 5.9 homework exposures completed | Standard Deviation 1.3 |