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

NCT06494319 | Recruiting

• 1 other identifier: HSC-MS-23-0547
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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),

Conditions

PTSD; Trauma and Stressor Related Disorders; Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)

  This is a 20 item questionnaire , each is scored from 0(not at all) -4( extremely)for a maximum score of 80, higher score indicating worse outcome

  end of study (about 11-14 weeks after baseline)

• Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4

  This is a 10 item questionnaire , each is scored from 0(not true at all) to 4(true nearly all the time) for a maximum score of 40, higher score indicating better outcome

  end of study (about 11-14 weeks after baseline)

• Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8)

  This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  4 weeks after baseline

• Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)

  This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  8 weeks after baseline

• Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

  This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome

  end of study (about 11-14 weeks after baseline)

• Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath

  Heart rate is measured in beats per minute

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath

  Heart rate variability is measured via a mathematical algorithm called coherence

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath

  Achievement is measured via mathematical equation that includes coherence and heart rate variability and beats per minute over time. Higher achievement is associated with higher coherence sustained over time.

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

  The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).

  4-6 weeks(mid treatment)

• Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

  The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).

  6-8 weeks (mid treatment)

• Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)

  The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).

  end of treatment (11-14 weeks)

Secondary Outcomes (5)

• Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in severity of depression as assessed by the Patient Health Questionnaire (PHQ-9)

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference scale

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

• Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)

  Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)

Study Arms (2)

SIT NAVIGATOR plus Stress NAVIGATOR group

EXPERIMENTAL

Behavioral: Stress NAVIGATOR (Mobile Health Application); Behavioral: SIT NAVIGATOR

SIT NAVIGATOR only group

ACTIVE COMPARATOR

Behavioral: SIT NAVIGATOR

Interventions

Stress NAVIGATOR (Mobile Health Application) BEHAVIORAL

Participants will be prompted to complete their assessments each week (or upon completion of each session) via the Stress NAVIGATOR mobile health app

SIT NAVIGATOR plus Stress NAVIGATOR group

SIT NAVIGATOR BEHAVIORAL

Participants will complete 11 self-paced virtual SIT sessions in the SIT-NAVIGATOR classroom. Participants will be asked to complete at least one session per week, in a minimum of 12 weeks and a maximum of 14 weeks.

SIT NAVIGATOR only group; SIT NAVIGATOR plus Stress NAVIGATOR group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• US Military Veterans / Service Members
• diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \>33
• history of combat trauma and/or military service in an imminent danger pay area
• be fluent in English.
• 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.
• have access to a SmartPhone or tablet to utilize the mobile health app and/OR access the virtual classroom.
• agree to undergo psychometric testing and participate in ongoing assessments throughout the study duration.
• be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study.

You may not qualify if:

• Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
• Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
• 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).
• They are currently undergoing another form of treatment other than supportive therapy (\> 2 times per month).
• Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
• Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah Jackson, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Jackson, PhD

CONTACT

(281) 825-9923; Sarah.E.Jackson@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The first 10 participants will do the treatment via the canvas classroom virtually and participate in user experience interviews to improve the quality of the treatment and improve the user experience.Next, the second group of 10 participants will do the treatment with the canvas classroom aided by a mobile health application.These participants will also participate in user experience interviews to improve the quality of the treatment and improve the user experience.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: May 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)