One-Session Treatment vs Relaxation Training for Dental Phobia
(SAFE-D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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:
* Is one intervention more effective in reducing the severity of dental phobia 6 months after treatment?
* Are improvements in dental fear and anxiety maintained 12 months after treatment?
* How do changes in fear-related learning and beliefs contribute to treatment outcomes?
* How acceptable and practical are these treatments for youth, their parents, and the professionals delivering the treatments?
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:
* Complete an initial assessment of their dental fear and anxiety.
* Participate in their assigned treatment.
* Complete assessments 1 week, 6 months, and 12 months after treatment to evaluate changes in dental fear, anxiety, and related beliefs and behaviors.
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.
Who Is on the Research Team?
Laura D Deligman, Ph.D.
Principal Investigator
University of Texas Rio Grande Valley
Joseph H Hovey, Ph.D.
Principal Investigator
University of Texas Rio Grande Valley
Are You a Good Fit for This Trial?
This trial is for children and teens who have a strong fear or phobia of going to the dentist. Participants should be able to take part in therapy sessions and complete follow-up assessments.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- One-Session Treatment for Dental Phobia (OSTD)
- Psychoeducation and Relaxation Training (RELAX)
Trial Overview
The study compares two treatments for dental phobia: a single intensive session (OSTD) versus several sessions focused on education about anxiety and relaxation techniques (RELAX). Participants are randomly assigned to one group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
OSTD is a cognitive behavioral treatment with the main component of the treatment being massed exposure exercises guided by an inhibitory learning framework.
RELAX is a psychoeducational intervention paired with progressive muscle relaxation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Rio Grande Valley
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
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