RECRUITING

Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App

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Conditions

PTSDTrauma and Stressor Related DisordersTraumatic Brain InjuryveteranPost Traumatic Stress Disorder (PTSD)Military

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),

Official Title

Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App

Quick Facts

Study Start:2024-05-28
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06494319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * US Military Veterans / Service Members
  2. * diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \>33
  3. * history of combat trauma and/or military service in an imminent danger pay area
  4. * be fluent in English.
  5. * be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
  6. * have access to a SmartPhone or tablet to utilize the mobile health app and/OR access the virtual classroom.
  7. * agree to undergo psychometric testing and participate in ongoing assessments throughout the study duration.
  8. * be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study.
  1. * Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
  2. * Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
  3. * Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score \> 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (\< 3 times weekly).
  4. * They are currently undergoing another form of treatment other than supportive therapy (\> 2 times per month).
  5. * Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
  6. * Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.

Contacts and Locations

Study Contact

Sarah Jackson, PhD
CONTACT
(281) 825-9923
Sarah.E.Jackson@uth.tmc.edu

Principal Investigator

Sarah Jackson, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Sarah Jackson, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-28
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • veteran
  • Post Traumatic Stress Disorder (PTSD)
  • Traumatic Brain Injury
  • Military

Additional Relevant MeSH Terms

  • PTSD
  • Trauma and Stressor Related Disorders
  • Traumatic Brain Injury