Trial Outcomes & Findings for Bringing Exposure Therapy to Real-Life Context With Augmented Reality (NCT NCT03649347)

Results Overview

Fear of spiders / severity of phobia will be measured via the Fear of Spiders questionnaire in order to determine how treatment has impacted the fear. The fear of spiders questionnaire is 18 items scored on a scale from 1-7, for a low score of 18 and a high score of 126. Total score is calculated by adding all items together. Higher scores are indicative of greater fear of spiders.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Change in score on Fear of Spiders questionnaire from baseline to post-treatment, at one month follow-up

Results posted on

2022-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	AR Therapy Intervention for Spider Phobia AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.	No Treatment Control Group for Spider Phobia The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AR Therapy Intervention for Spider Phobia n=13 Participants Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	No Treatment Control Group for Spider Phobia n=12 Participants This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).	AR Therapy Intervention for Fear of Snakes Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	No Treatment Control Group for Fear of Snakes This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants	0 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	12 Participants n=12 Participants	0 Participants	0 Participants	25 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants	0 Participants	0 Participants n=25 Participants
Age, Continuous	23 years n=13 Participants	24 years n=12 Participants	—	—	23.5 years n=25 Participants
Sex/Gender, Customized Sex · Female	9 Participants n=13 Participants	7 Participants n=12 Participants	0 Participants	0 Participants	16 Participants n=25 Participants
Sex/Gender, Customized Sex · Male	3 Participants n=13 Participants	3 Participants n=12 Participants	0 Participants	0 Participants	6 Participants n=25 Participants
Sex/Gender, Customized Sex · Did Not Report	1 Participants n=13 Participants	2 Participants n=12 Participants	0 Participants	0 Participants	3 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 Participants n=13 Participants	12 Participants n=12 Participants	0 Participants	0 Participants	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: Change in score on Fear of Spiders questionnaire from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

Fear of spiders / severity of phobia will be measured via the Fear of Spiders questionnaire in order to determine how treatment has impacted the fear. The fear of spiders questionnaire is 18 items scored on a scale from 1-7, for a low score of 18 and a high score of 126. Total score is calculated by adding all items together. Higher scores are indicative of greater fear of spiders.

Outcome measures

Outcome measures
Measure	AR Therapy Intervention for Spider Phobia n=13 Participants AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.	No Treatment Control Group for Spider Phobia n=12 Participants The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.	AR Therapy Intervention for Snake Phobia Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	No Treatment Control Group for Snake Phobia This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
Spider Phobia Baseline Score	104 score on a scale Standard Deviation 10.8	111 score on a scale Standard Deviation 11.7	—	—
Spider Phobia Post Treatment Score	43.2 score on a scale Standard Deviation 22.5	102 score on a scale Standard Deviation 18.4	—	—

SECONDARY outcome

Timeframe: Change in score on Behavioral Approach Test from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

A measure of the closest distance the patient can have to the feared object. Scored from 0-12 based on distance away in meters from feared object and interaction with feared object. The score is given based on participant interaction, therefore one value is chosen. Higher values closer to 12 show greater comfortability and ability to interact with the feared object.

Outcome measures

Outcome measures
Measure	AR Therapy Intervention for Spider Phobia n=13 Participants AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.	No Treatment Control Group for Spider Phobia n=12 Participants The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.	AR Therapy Intervention for Snake Phobia Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	No Treatment Control Group for Snake Phobia This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
Behavioral Approach Test--Ability to Confront Phobia Baseline Distance	6.27 meters Standard Deviation 2.26	7.5 meters Standard Deviation 5.16	—	—
Behavioral Approach Test--Ability to Confront Phobia Post Treatment Distance	0 meters Standard Deviation 0	6 meters Standard Deviation 3.03	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score on Snake Anxiety questionnaire from baseline to post treatment (immediately following the last exposure therapy session)

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

Fear of snakes will be measured via the snake anxiety questionnaire. The Snake Anxiety questionnaire is a 30 item true or false questionnaire. The number of true or false responses are summed. Higher number of true responses is indicative of greater phobia.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in score on Spider Phobia questionnaire from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

The Spider Phobia questionnaire is a 31 item questionnaire with yes or no responses. All items are added together for a total score. 9 items are reverse scored. The minimum score is 0 and the maximum score is 31. Higher scores are indicative of more severe phobia. This questionnaire will serve as an additional measure of spider phobia to the primary outcome measure.

Outcome measures

Outcome measures
Measure	AR Therapy Intervention for Spider Phobia n=13 Participants AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.	No Treatment Control Group for Spider Phobia n=12 Participants The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.	AR Therapy Intervention for Snake Phobia Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	No Treatment Control Group for Snake Phobia This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
Spider Phobia--additional Measure Baseline Score	20.4 score on a scale Standard Deviation 4.25	25.7 score on a scale Standard Deviation 3.23	—	—
Spider Phobia--additional Measure Post Treatment Score	11.1 score on a scale Standard Deviation 5.69	24.9 score on a scale Standard Deviation 3.14	—	—

Adverse Events

AR Therapy Intervention for Spider Phobia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment Control Group for Spider Phobia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Gorski, Research Coordinator

Stress, Trauma, and Anxiety Research Clinic (STARC) at Wayne State University

Phone: 313-577-9202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place