Phobic DisordersNCT03461016
Smartphone-Based Exposure Treatment for Dental Anxiety
A study testing Exposure Therapy in people with Phobic Disorders and Dental Anxiety, run by West Virginia University at 1 site in United States.
Trial summary
Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phobic Disorders, Dental Anxiety, Treatment Outcome
- What is being tested?
- Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fluency in the English language
- being 18 years of age or older
- own or have access to a smartphone
- have an e-mail account
Who cannot join
- Reporting a low level of discomfort with dental-related care (i.e., less than a rating of "somewhat" on a single-item dental fear question)
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: Randomized Clinical Trial of Smartphone-Based Exposure of Dental Anxiety
Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Technological advancements, as with smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic material on a smartphone might promote increased adherence in conducting self-directed exposure. Additionally, exposure can incorporate phobic material from different perspectives (i.e., first-person or third-person), which is one factor that may impact treatment effectiveness. Participants will be randomly assigned to a treatment or control condition, and complete a pre-assessment and then a post-assessment two weeks later. The assessment consists of a multimodal approach (e.g., self-report, physiological response, and overt behavior). Participants in the treatment condition will be instructed to watch a standard exposure video of a dental examination and prophylaxis three times daily for two weeks. One week of videos was shown in a first-person perspective and the same video will be shown in a third-person perspective for one week. The study can demonstrate the potential utility of smartphone-based self-directed exposure therapy for specific phobia.
Read the detailed description
- Recruitment efforts will be made in the community via advertisements and online advertisements (e.g., Craigslist, Facebook).
- Prospective participants will contact the investigators via email or by calling the study phone number listed on the advertisements.
- Once a participant indicates interest by contacting study personnel, a 5-minute screening interview will be conducted with the prospective participant using the screening questionnaire to ensure eligibility criteria are met. For those who do not qualify or agree to participate, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room.
- After written agreement to enlist in the study, participants are randomly assigned to group (i.e., treatment or control) by previously prepared sealed opaque envelopes.
- Participants will complete the demographic questionnaire, the Dental Fear Survey, and the investigator will complete the specific phobia section of the ADIS-5 with the participant.
- Then a Behavioral Avoidance Task will be conducted with the participants
- One-minute baseline, in which the participant sat quietly.
- Then nine dental-related steps will be completed each lasted 30 seconds, and a SUDS rating was collected at each step.
- After completing the Behavioral Avoidance Task, the investigator provides a 15-minute demonstration to the participants.
- The control group watched a video on their smartphone about smartphone capabilities as an attention control.
- The treatment group was shown how to conduct self-directed exposure therapy and rate SUDS on their smartphone.
- The video is a typical preventive visit to the dentist, including walking into the dental office, being called back for treatment by the dental assistant, sitting in the dental chair, and seeing the hygienist perform a teeth cleaning. ii. The video is presented in a first and third person perspective, and the order is randomly assigned (e.g., view the first person perspective video during week 1 of treatment and then third person perspective during week 2 of treatment).
- Researcher will model how to rate SUDS prior to watching the exposure video, how to access the exposure video, how to rate actual SUDS experienced during the video, and how to either continue to the next video or stop the exposure session.
- Participants are advised that watching the exposure video three times per day is the ideal, which may match the amount of exposure in a typical 50-minute treatment session.
- One time per day was the suggested minimum, and five times per day was the suggested maximum.
- An email will be sent to participants in the treatment group daily to remind them to conduct the exposure session over the two weeks of treatment.
- Participants follow the link each day with their smartphones. Before each exposure video, participants rate expected distress on the SUDS. Then asked to watch a video depicting dental care-related material. After viewing the exposure video, participants rated actual distress experienced on the SUDS.
- The participants then are immediately prompted to watch the video again. If the participant chooses to watch the video again, the participant will do the same procedure of pre-rating anxiety, watching the video, and post-rating anxiety.
- Finally, participants are prompted to complete the procedure a third time. After completing the procedure three times, the participants are no longer prompted, however, they had the ability to complete the procedure up to two more times if they so desired.
- One week after the pre-assessment, participants are contacted via telephone by the investigator to complete measures and schedule the post-assessment session.
- Participants in the control condition will complete the Dental Fear Survey
- Participants in the treatment condition will complete the Dental Fear Survey and the IGroup Presence Questionnaire.
- Participants return for the post-assessment session at least two-weeks after the pre-assessment to complete questionnaires and conduct the Behavioral Avoidance Task again.
- Participants in the control condition will complete the Dental Fear Survey
- Participants in the treatment condition will complete the Dental Fear Survey, IGroup Presence Questionnaire, and Acceptance and Acceptability Rating Profile.
- Conditions
- Phobic Disorders, Dental Anxiety, Treatment Outcome
- Being tested
- Exposure Therapy
- Keywords
- Smartphones, Exposure Therapy, Dental Anxiety
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure TherapyBehavioural
"Exposure therapy is a form of behavior therapy that is widely used to treat anxiety disorders, including specific phobia. It involves systematic and repeated confrontation with a feared stimulus. It works by (a) implosive therapy, habituation, in which repeated exposure reduces anxiety over time by a process of extinction; (b) disconfirming fearful predictions; and (c) increasing feelings of self-efficacy and mastery. In vivo exposure [is] a type of exposure therapy, generally used for treating individuals with phobias, obsessive compulsive disorder, and other anxiety disorders, in which the client directly experiences anxiety-provoking situations or stimuli in real-world conditions." (VandenBos, 2015)
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-Based Exposure Therapy | Experimental | Participants assigned to the Smartphone-Based Exposure Therapy group will receive two weeks of exposure therapy via their smartphone. Participants will have the opportunity to receive up to 50 minutes of exposure video intervention daily for the two weeks. Receives: Behavioral: Exposure Therapy |
| Waitlist Control | No intervention | Participants who have been randomly assigned to participate in the Waitlist Control group will not receive treatment; however, after the two weeks of no intervention, participants in this condition will be offered the same treatment as the treatment condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Fear Survey (scale 20-item)
Participant self-report of dental care-related fear and anxiety, range of 20-100
Measured: Change from Baseline to 14 days
Secondary outcomes (2)
Change in Subjective Units of Distress (scale 1-item)
Participant self-report of Anxiety, scale of 0-100
Measured: Change from Baseline to 14 days
Acceptability (scale 8-item)
Participant self-report of the acceptability of treatment, range of 1-48
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Apr 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel W. McNeil, PhD, West Virginia University
- Investigators
- Daneil W McNeil, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461016
- Sponsor's protocol ID
- 1506718933
- Status last verified
- May 2020
- First submitted
- 16 Feb 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VandenBos, G. R. (Ed.) (2015). APA dictionary of psychology. Washington, DC: American Psychological Association.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Smartphone-Based Exposure of Dental Anxiety
- ClinicalTrials.gov ID
- NCT03461016
- Acronym / sponsor ID
- 1506718933
- Conditions
- Phobic Disorders, Dental Anxiety, Treatment Outcome
- Keywords
- Smartphones, Exposure Therapy, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Technological advancements, as with smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic material on a smartphone might promote increased adherence in conducting self-directed exposure. Additionally, exposure can incorporate phobic material from different perspectives (i.e., first-person or third-person), which is one factor that may impact treatment effectiveness. Participants will be randomly assigned to a treatment or control condition, and complete a pre-assessment and then a post-assessment two weeks later. The assessment consists of a multimodal approach (e.g., self-report, physiological response, and overt behavior). Participants in the treatment condition will be instructed to watch a standard exposure video of a dental examination and prophylaxis three times daily for two weeks. One week of videos was shown in a first-person perspective and the same video will be shown in a third-person perspective for one week. The study can demonstrate the potential utility of smartphone-based self-directed exposure therapy for specific phobia.
Detailed description
- Recruitment efforts will be made in the community via advertisements and online advertisements (e.g., Craigslist, Facebook).
- Prospective participants will contact the investigators via email or by calling the study phone number listed on the advertisements.
- Once a participant indicates interest by contacting study personnel, a 5-minute screening interview will be conducted with the prospective participant using the screening questionnaire to ensure eligibility criteria are met. For those who do not qualify or agree to participate, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room.
- After written agreement to enlist in the study, participants are randomly assigned to group (i.e., treatment or control) by previously prepared sealed opaque envelopes.
- Participants will complete the demographic questionnaire, the Dental Fear Survey, and the investigator will complete the specific phobia section of the ADIS-5 with the participant.
- Then a Behavioral Avoidance Task will be conducted with the participants
- One-minute baseline, in which the participant sat quietly.
- Then nine dental-related steps will be completed each lasted 30 seconds, and a SUDS rating was collected at each step.
- After completing the Behavioral Avoidance Task, the investigator provides a 15-minute demonstration to the participants.
- The control group watched a video on their smartphone about smartphone capabilities as an attention control.
- The treatment group was shown how to conduct self-directed exposure therapy and rate SUDS on their smartphone.
- The video is a typical preventive visit to the dentist, including walking into the dental office, being called back for treatment by the dental assistant, sitting in the dental chair, and seeing the hygienist perform a teeth cleaning. ii. The video is presented in a first and third person perspective, and the order is randomly assigned (e.g., view the first person perspective video during week 1 of treatment and then third person perspective during week 2 of treatment).
- Researcher will model how to rate SUDS prior to watching the exposure video, how to access the exposure video, how to rate actual SUDS experienced during the video, and how to either continue to the next video or stop the exposure session.
- Participants are advised that watching the exposure video three times per day is the ideal, which may match the amount of exposure in a typical 50-minute treatment session.
- One time per day was the suggested minimum, and five times per day was the suggested maximum.
- An email will be sent to participants in the treatment group daily to remind them to conduct the exposure session over the two weeks of treatment.
- Participants follow the link each day with their smartphones. Before each exposure video, participants rate expected distress on the SUDS. Then asked to watch a video depicting dental care-related material. After viewing the exposure video, participants rated actual distress experienced on the SUDS.
- The participants then are immediately prompted to watch the video again. If the participant chooses to watch the video again, the participant will do the same procedure of pre-rating anxiety, watching the video, and post-rating anxiety.
- Finally, participants are prompted to complete the procedure a third time. After completing the procedure three times, the participants are no longer prompted, however, they had the ability to complete the procedure up to two more times if they so desired.
- One week after the pre-assessment, participants are contacted via telephone by the investigator to complete measures and schedule the post-assessment session.
- Participants in the control condition will complete the Dental Fear Survey
- Participants in the treatment condition will complete the Dental Fear Survey and the IGroup Presence Questionnaire.
- Participants return for the post-assessment session at least two-weeks after the pre-assessment to complete questionnaires and conduct the Behavioral Avoidance Task again.
- Participants in the control condition will complete the Dental Fear Survey
- Participants in the treatment condition will complete the Dental Fear Survey, IGroup Presence Questionnaire, and Acceptance and Acceptability Rating Profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-Based Exposure Therapy | Experimental | Behavioral: Exposure TherapyParticipants assigned to the Smartphone-Based Exposure Therapy group will receive two weeks of exposure therapy via their smartphone. Participants will have the opportunity to receive up to 50 minutes of exposure video intervention daily for the two weeks. |
| Waitlist Control | No intervention | –Participants who have been randomly assigned to participate in the Waitlist Control group will not receive treatment; however, after the two weeks of no intervention, participants in this condition will be offered the same treatment as the treatment condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fluency in the English language
- being 18 years of age or older
- own or have access to a smartphone
- have an e-mail account
Key exclusion criteria (1 listed)
- Reporting a low level of discomfort with dental-related care (i.e., less than a rating of "somewhat" on a single-item dental fear question)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure Therapy"Exposure therapy is a form of behavior therapy that is widely used to treat anxiety disorders, including specific phobia. It involves systematic and repeated confrontation with a feared stimulus. It works by (a) implosive therapy, habituation, in which repeated exposure reduces anxiety over time by a process of extinction; (b) disconfirming fearful predictions; and (c) increasing feelings of self-efficacy and mastery. In vivo exposure [is] a type of exposure therapy, generally used for treating individuals with phobias, obsessive compulsive disorder, and other anxiety disorders, in which the client directly experiences anxiety-provoking situations or stimuli in real-world conditions." (VandenBos, 2015) | Behavioural | Smartphone-Based Exposure Therapy |
Primary outcome
Change in Dental Fear Survey (scale 20-item)
Time frame: Change from Baseline to 14 days
Participant self-report of dental care-related fear and anxiety, range of 20-100
2 secondary outcomes
Change in Subjective Units of Distress (scale 1-item)
Time frame: Change from Baseline to 14 days
Acceptability (scale 8-item)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- BackgroundVandenBos, G. R. (Ed.) (2015). APA dictionary of psychology. Washington, DC: American Psychological Association.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daneil W McNeil, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy in people with Phobic Disorders and Dental Anxiety, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dental Fear Survey (scale 20-item) (time frame: Change from Baseline to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.