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Online Therapy for Post-Traumatic Stress Disorder (ReSeT Trial)
N/A
Waitlist Available
Led By Heather T Keenan, MDCM
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treated for an injury in the ED or hospitalized
8 years to 17 years at enrollment
Must not have
Currently receiving psychotherapy
Moderate or severe traumatic brain injury (GCS less than 13)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
Summary
This trial tests online lessons and internet-based therapy for children with stress symptoms after an injury. The goal is to help them change negative thoughts and gradually face things that remind them of the trauma.
Who is the study for?
This trial is for children aged 8-17 who have been treated in the ER or hospitalized for an injury, with internet at home and living with a parent or guardian. They must speak English but can't join if they've had certain psychiatric disorders, are already in psychotherapy, suffered abuse-related injuries, severe brain injury, intellectual disabilities, were hospitalized over 30 days for the injury, or lost a family member/friend at the time of injury.
What is being tested?
The study tests a web-based educational program combined with telehealth therapy to help kids with post-traumatic stress symptoms after an injury. Participants are randomly split into two groups: one receives this online therapy while the other gets usual care without these additional resources.
What are the potential side effects?
Since this intervention involves non-medical treatment (education and therapy), typical medical side effects aren't expected. However, participants may experience emotional discomfort when discussing traumatic events during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was treated in the emergency department or was hospitalized for an injury.
Select...
I am between 8 and 17 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in psychotherapy.
Select...
I have had a serious head injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-Traumatic Stress Disorder
Secondary study objectives
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
Pediatric Quality of Life Inventory (PedsQL)
Anxiety
Other study objectives
Connor David Resilience Scale
PROMIS Pediatric Anger
PROMIS Pediatric Anxiety
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RESETExperimental Treatment1 Intervention
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
Group II: ControlActive Control1 Intervention
Children will receive usual post-trauma care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RESET
2021
N/A
~100
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD include trauma-focused therapies like Cognitive Behavioral Therapy (CBT) and Exposure Therapy, which help patients process and reframe traumatic memories, reducing their emotional impact and avoidance behaviors. Pharmacological treatments, such as SSRIs, work by balancing neurotransmitters in the brain to alleviate symptoms of anxiety and depression.
These mechanisms are crucial as they address both psychological and biological aspects of PTSD, offering a comprehensive treatment approach. Web-based educational modules and telehealth therapy provide accessible and flexible options for delivering these treatments, ensuring consistent care for patients.
Fully remote intensive trauma-focused treatment for PTSD and Complex PTSD.
Fully remote intensive trauma-focused treatment for PTSD and Complex PTSD.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,027 Previous Clinical Trials
2,659,930 Total Patients Enrolled
University of UtahLead Sponsor
1,130 Previous Clinical Trials
1,793,478 Total Patients Enrolled
Heather T Keenan, MDCMPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently experienced the loss of a loved one due to injury or death.I am currently in psychotherapy.I was treated in the emergency department or was hospitalized for an injury.I have had a serious head injury.You have a significant intellectual disability.Both my child and I can speak English.You were hurt on purpose by someone else or due to substance abuse.I am between 8 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: RESET
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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