What side effects are associated with this type of intervention?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include cognitive-behavioral therapy (CBT), particularly trauma-focused CBT, and pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Web-based educational modules and telehealth therapy, which are forms of CBT, generally have fewer side effects compared to pharmacotherapy. However, patients may experience temporary increases in anxiety or distress as they confront traumatic memories. SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased risk of suicidal thoughts, particularly in younger populations. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. These medications have shown efficacy in reducing PTSD symptoms. Additionally, prazosin, an alpha-adrenergic receptor blocker, is often used off-label to manage PTSD-related nightmares and sleep disturbances. While the trial on web-based educational modules and telehealth therapy focuses on psychological support, it complements these pharmacological treatments by providing accessible, non-pharmacologic interventions aimed at improving overall mental health and coping strategies for PTSD patients.

What other types of research exist?

Promising novel alternatives for PTSD treatment in 2024 include MDMA-assisted psychotherapy, which has shown potential in clinical trials for reducing PTSD symptoms, and equine-assisted therapy, which has been explored in open trials for military veterans. Additionally, psilocybin-assisted psychotherapy is emerging as a potential treatment for psychiatric distress, including PTSD, with ongoing research supporting its efficacy.

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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

No Placebo-Only Group

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 below

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I was treated in the emergency department or was hospitalized for an injury.

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I am between 8 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in psychotherapy.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 4Eligibility criteria met

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.