An interventional study of One-Session Treatment for Dental Phobia (OSTD) and Psychoeducation and Relaxation Training (RELAX) in Dental Phobia, Dental Anxiety in Children and Dental Fear, sponsored by University of Texas Rio Grande Valley. Recruiting at 2 sites in United States. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Texas Rio Grande Valley · Not applicable, Interventional, and Treatment
Among 2,269 studies in Anxiety Disorders with a site in United States — 398 open to participants now, 503 under way, 13 of them phase 3. Anxiety Disorders · United States.
Among the 2,269 studies in Anxiety Disorders with a site in United States, this one is the 493rd largest by planned enrollment of the 2,045 interventional ones that give a count, is one of 134 that started in 2026, is one of 1,609 with no phase, reaches primary completion later than 485 of the 500 other live ones, and was the 2,265th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →398 of the 2,269 studies in Anxiety Disorders with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 18+
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
Columbia University · Sites in United States
Ages 12–21
Ohio State University · Sites in United States
Ages 21–65
Ohio State University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 7 Years to 16 Years · all sexes · no healthy volunteers.
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2,269 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 119 · Phase 2 201 · Phase 3 95 · Phase 4 88
First in 1983; this study’s year is marked. 134 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 68 across the 2,045 interventional studies, 156 across the 215 observational. Of the 1,599 that completed or were terminated, 503 (31%) have results posted.
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185 of 2,269 have an industry lead sponsor. The 10 most frequent:
University of Texas Rio Grande Valley is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
University of Texas Rio Grande Valley has 1 study filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
218 of the studies in Anxiety Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT06273527Phase 3University of California, San DiegoEnhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) | 2027-06-01 |
| NCT07123467Phase 3Wayne State UniversityCannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder | 2027-08-31 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
Add all 218 to your calendar (.ics) → With an account.
Among the 2,269 studies in Anxiety Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to compare two treatments for dental phobia in children and adolescents: One-Session Treatment for Dental Phobia (OSTD) and psychoeducation plus relaxation training (RELAX).
The main questions this study aims to answer are:
Researchers will enroll approximately 160 youth with dental phobia and randomly assign them to one of two treatment groups. Participants will receive either OSTD or RELAX.
Participants will:
Researchers will compare the two groups to determine which treatment is more effective in reducing dental phobia, whether improvements last over time, and how changes in fear-related learning may contribute to treatment outcomes.
The study will examine inhibitory learning as a potential mechanism underlying improvements in dental phobia following One-Session Treatment for Dental Phobia (OSTD) compared with psychoeducation and relaxation training (RELAX). Inhibitory learning involves developing new associations that reduce the influence of previously learned fear responses. The study will investigate whether changes in implicit associations with dental-related stimuli and beliefs about potential harm help explain treatment-related improvements in dental phobia.
Exploratory analyses will examine potential predictors and moderators of treatment outcomes at 6 and 12 months post-treatment. Variables of interest include coping efficacy, habituation, fear activation, acculturation, outcome expectancy, fear of pain, cognitive vulnerability, comorbidity, and distress tolerance. Multiple regression models will evaluate associations between these variables and treatment outcomes, including dental phobia severity, dental anxiety symptoms, individualized treatment goal attainment, and dental cleaning appointment attendance. Selected analyses will be restricted to participants receiving OSTD when the predictor is specific to that intervention. Additional analyses will examine whether baseline characteristics moderate differences in treatment outcomes between OSTD and RELAX.
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.
To be eligible to participate in this study, an individual must meet all the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria at baseline will be excluded from participating in this study:
If the parent-reports:
OSTD is a cognitive behavioral treatment with the main component of the treatment being massed exposure exercises guided by an inhibitory learning framework.
Behavioral: One-Session Treatment for Dental Phobia (OSTD)
RELAX is a psychoeducational intervention paired with progressive muscle relaxation.
Behavioral: Psychoeducation and Relaxation Training (RELAX)
OSTD is a single-session behavioral intervention designed to reduce dental phobia in children and adolescents. The intervention uses individualized, graduated exposure to feared dental situations and procedures. Exposure activities are guided by a participant-specific fear hierarchy and cognitive-behavioral assessment developed before treatment. During the treatment session, participants engage in exposure exercises intended to help them confront feared dental situations and develop new learning about anticipated negative outcomes.
RELAX is a single-session behavioral comparison intervention consisting of psychoeducation and relaxation training for children and adolescents with dental phobia. The intervention includes information about dental-related fear and anxiety and instruction in relaxation strategies, including progressive muscle relaxation. Participants receive guided relaxation training intended to support the management of anxiety associated with dental situations.
Change in Dental Phobia Severity From Baseline to 6 Months Post-Treatment
Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Information obtained from parent and child interviews will be used to establish a consensus Clinician Severity Rating (CSR). The primary outcome is the consensus CSR at 6 months post-treatment. Score range is 0 to 8, lower scores indicate less severe dental phobia. Treatment group differences will be evaluated using regression analysis adjusting for baseline CSR and prespecified covariates.
Time frame: 6 months post-treatment
Change in Dental Phobia Severity From Baseline to 12 Months Post-Treatment
Dental phobia severity will be assessed using the dental phobia module of the Anxiety Disorders Interview Schedule for Children. Parent and child interview information will be used to establish a consensus Clinician Severity Rating (CSR). Score range is 0 to 8, lower scores indicate less severe dental phobia. The 12-month consensus CSR will be compared between treatment groups, adjusting for baseline CSR and prespecified covariates.
Time frame: 12 months post-treatment
Change in Dental Anxiety Symptoms From Baseline to 12 Months Post-Treatment
Dental anxiety symptoms will be assessed using the Modified Child Dental Anxiety Scale (MCDAS) and a modified parent version (MDAS-P) administered to children and parents. Scores will be used to evaluate dental anxiety at 1 week, 6 months, and 12 months post-treatment. Treatment group differences will be evaluated at each follow-up assessment using regression models adjusting for baseline dental anxiety and prespecified covariates. Higher scores indicate greater dental anxiety.
Time frame: 1 week, 6 months, and 12 months post-treatment
Attainment of Personalized Treatment Goal at 6 Months and 12 Months Post Treatment
Treatment goal attainment will be evaluated using a personalized treatment goal identified by the participant's family. Goal attainment will be classified into three ordered categories: no attainment, partial attainment, and full attainment. Treatment group differences will be evaluated using ordinal regression models.
Time frame: 6 months and 12 months post-treatment
Attendance at Recommended Dental Cleaning Appointment
Compliance with dental health treatment recommendations will be assessed by determining whether the participant attended a recommended dental cleaning appointment. Attendance will be recorded as a binary outcome (attended or did not attend). Treatment group differences will be evaluated at the 6-month and 12-month follow-up assessments.
Time frame: 6 months and 12 months post-treatment
Implicit Associations With Dental Stimuli Assessed by the Affect Misattribution Procedure (AMP)
Implicit associations with dental-related stimuli will be assessed using the Affect Misattribution Procedure (AMP). AMP performance will be examined as an indicator of inhibitory learning and evaluated as a potential mediator of treatment outcomes. The measure will be assessed before treatment and at subsequent assessment points to examine treatment-related changes in automatic affective responses to dental stimuli.
Time frame: Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
Change in Outcome Expectancy Violation from Baseline to 6 Months Post-Treatment
Beliefs about potential harm associated with dental treatment will be assessed using the Harm Beliefs component of the Harm Beliefs and Coping Efficacy Interview. Changes in harm beliefs will be evaluated as an indicator of outcome expectancy violation and examined as a potential mediator of treatment outcomes. Perceived Likelihood (Probability): Rating how certain the participant is that a worst-case scenario will happen (from 0 Not Going to Happen to 8 Definitely Going to Happen). Perceived Severity (Impact): Rating the magnitude of the anticipated danger (from 0 Not Bad at All to 8 Very, Very Bad).
Time frame: Baseline (within 14 days before treatment), Treatment (Day 0), 1 week post-treatment, and 6 months post-treatment
Parent-Reported Treatment Satisfaction
Parent satisfaction with the assigned treatment will be assessed using the parent version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate parent-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction.
Time frame: 1 week, 6 months, and 12 months post-treatment
Child-Reported Treatment Satisfaction
Child satisfaction with the assigned treatment will be assessed using the child version of the Treatment Satisfaction Survey. Scores will be compared between OSTD and RELAX at each follow-up assessment to evaluate child-reported treatment satisfaction. Scores range from 12-60 with higher scores indicating more satisfaction.
Time frame: 1 week, 6 months, and 12 months post-treatment
Interventionist-Reported Treatment Satisfaction
Interventionists will complete the Acceptability of Intervention Measure (AIM) to evaluate their perceptions of treatment acceptability. Scores will be compared between OST-D and RELAX to assess differences in perceived acceptability. Interventionists will complete the Feasibility of Intervention Measure (FIM) to evaluate their perceptions of the feasibility of delivering the treatment. Scores will be compared between OST-D and RELAX to assess differences in perceived treatment feasibility. Interventionists will complete the Intervention Appropriateness Measure (IAM) to evaluate their perceptions of the appropriateness of the treatment for youth with dental phobia. Scores will be compared between OST-D and RELAX. Scores range from 4-20 with higher scores indicating greater acceptability, feasibility and appropriateness for each respective measure.
Time frame: Within 6 months of completion of treatment delivery for all study participants
Treatment Fidelity and Interventionist Competence
Treatment fidelity and interventionist competence will be assessed using the study-specific Fidelity and Competence Coding Form. Selected treatment sessions will be evaluated to assess adherence to the assigned intervention protocol and competence in treatment delivery. 25% of sessions in each condition will be coded for fidelity and competence.
Time frame: Treatment (Day 0)
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Mar 2030, 40 months later.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 40 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Texas Rio Grande Valley