An interventional study of Exposure Therapy in Phobic Disorders, Dental Anxiety and Treatment Outcome, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-26.
Sponsored by West Virginia University · Not applicable, Interventional, and Treatment
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.
Then a Behavioral Avoidance Task will be conducted with the participants
After completing the Behavioral Avoidance Task, the investigator provides a 15-minute demonstration to the participants.
i. 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.
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.
One week after the pre-assessment, participants are contacted via telephone by the investigator to complete measures and schedule the post-assessment session.
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.
84 studies on the registry are indexed under Phobic Disorders; 15 are open to participants now.
This study's enrollment of 37 is below the median of 66 across 69 interventional studies indexed under Phobic Disorders.
Browse Phobic Disorders studies →West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Exposure Therapy
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.
"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)
Change in Dental Fear Survey (scale 20-item)
Participant self-report of dental care-related fear and anxiety, range of 20-100
Time frame: Change from Baseline to 14 days
Change in Subjective Units of Distress (scale 1-item)
Participant self-report of Anxiety, scale of 0-100
Time frame: Change from Baseline to 14 days
Acceptability (scale 8-item)
Participant self-report of the acceptability of treatment, range of 1-48
Time frame: 14 days
Change in Behavioral Avoidance Task behavior
Nine steps of a simulated a dental examination
Time frame: Change from Baseline to 14 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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