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Internet-Based Intervention for Dental Anxiety

Phase 2

Waitlist Available

Led By Eugene M Dunne, PhD

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 75 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-dental anxiety intervention

Awards & highlights

Study Summary

This trial is examining the efficacy of an internet-based intervention in the reduction of dental anxiety. The study has two primary objectives: to compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention; and to compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. The study also has two secondary objectives: to examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental

Who is the study for?

This trial is for adults aged 18-75 who speak and understand English well, have high dental anxiety as measured by the MDAS, and experience at least mild impairment from this anxiety. It's not suitable for individuals with psychosis, intellectual disabilities that affect focus, current suicidal or homicidal thoughts, or medical conditions where increased anxiety could be harmful.Check my eligibility

What is being tested?

The study tests an Internet-based intervention to reduce dental anxiety. It compares the effectiveness of the program when led by cognitive behavioral therapy experts versus trained dental staff. The trial also looks at whether distress tolerance and pain sensitivity influence outcomes.See study design

What are the potential side effects?

Since this is a psychological intervention focused on reducing dental anxiety through internet-based methods rather than medication or invasive procedures, it may not have typical 'side effects'. However, participants might experience discomfort discussing their anxieties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-dental anxiety intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-dental anxiety intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-dental anxiety intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).

Anxiety

Secondary outcome measures

Change in Attendance at Dental Appointments

Change in Avoidance Rating from the ADIS-5

Change in Distress and Interference Rating from the ADIS-5

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Tr2 groupExperimental Treatment1 Intervention

Participants assigned to Tr2 will complete the experimental dental anxiety management program, which will be facilitated by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.

Group II: Tr1 groupExperimental Treatment1 Intervention

Participants assigned to Tr1 will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.

Group III: Active controlActive Control1 Intervention

Participants assigned to the control group, will not complete the experimental dental anxiety management program at this time. They will complete study paperwork and watch a non-dental video for 45 minutes before their scheduled dental appointment. Immediately after the dental appointment, they will complete a brief interview with the research staff person.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)NIH

300 Previous Clinical Trials

848,162 Total Patients Enrolled

Temple UniversityLead Sponsor

296 Previous Clinical Trials

82,345 Total Patients Enrolled

Eugene M Dunne, PhDPrincipal InvestigatorAssistant Professor

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this clinical experiment offer participation?

"This clinical trial is seeking 450 individuals aged 18 to 75 who currently have anxiety related to dental health. The recruitment criteria necessitates that the applicant has an MDAS score of 19, or a 4-5 rate on two items from any five categories. Additionally, they must demonstrate mild impairment due to their condition at baseline interviews as measured by ADIS-5 and be conversant in English for comprehension purposes."

Answered by AI

What is the scope of enrolment for this clinical trial?

"That is correct. As indicated on clinicaltrials.gov, this research project has been open since July 24th 2019 and was last modified October 20th 2022. 450 participants will be recruited from a single location for the trial."

Answered by AI

Does this investigation permit individuals aged 18 and older to participate?

"Based on the eligibility criteria, patients between 18 and 75 years old are accepted into this clinical trial. For those younger than 18 or older than 65, there are 113 trials and 272 studies respectively to choose from."

Answered by AI

Are there any opportunities to join this scientific investigation currently?

"Clinicaltrials.gov reveals that this clinical trial is still on the lookout for appropriate patients. The study's initial listing was published on July 24th 2019 and most recently updated in October 20th 2022."

Answered by AI

What are the goals of this clinical experiment?

"The primary aim of this research is to evaluate the modification in dental anxiety as measured by the Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). Secondary metrics that shall be observed include Pain Sensitivity Index (PSI; Gross, 1992a), Pain Intensity Numeric Rating Scale (PI-NRS) and Distress Tolerance Scale (DTS; Simons & Gaher, 2005). The ADIS-5 will be administered at baseline assessments and one-month and three month follow ups."

Answered by AI

Is it safe for patients to seek online treatment for dental fear?

"Our internal assessment at Power determined that the safety of an online intervention for dental anxiety is a 2; this is supported by Phase 2 data which indicates some security but no proof of efficacy."

Answered by AI

Recent research and studies

Health and Quality of Life OutcomesJournal

Some Psychometric Properties of the Chinese Version of the Modified Dental Anxiety Scale with Cross Validation

Yuan, Siyang, Ruth Freeman, Satu Lahti, Ffion Lloyd-Williams, and Gerry Humphris. 2008. “Some Psychometric Properties of the Chinese Version of the Modified Dental Anxiety Scale with Cross Validation”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/1477-7525-6-22.

Evaluation and Program PlanningJournal

Assessment of Client/patient Satisfaction: Development of a General Scale

Larsen, Daniel L., C.Clifford Attkisson, William A. Hargreaves, and Tuan D. Nguyen. 1979. “Assessment of Client/patient Satisfaction: Development of a General Scale”. Evaluation and Program Planning. Elsevier BV. doi:10.1016/0149-7189(79)90094-6.

Journal of Anxiety DisordersJournal

A Critical Review of Approaches to the Treatment of Dental Anxiety in Adults

Gordon, Dina, Richard G. Heimberg, Marisol Tellez, and Amid I. Ismail. 2013. “A Critical Review of Approaches to the Treatment of Dental Anxiety in Adults”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2013.04.002.

Behaviour Research and TherapyJournal