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NCT Number: NCT06494319

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

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),

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Key information

Conditions

PTSD Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Sarah Jackson, PhD

CONTACT

[email protected]

281-825-9923

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

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

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

    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

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

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

    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

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

    Time frame: 4 weeks after baseline

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

    Time frame: 8 weeks after baseline

    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

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

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

    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

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

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

    Heart rate is measured in beats per minute

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

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

    Heart rate variability is measured via a mathematical algorithm called coherence

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

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

    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.

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

    Time frame: 4-6 weeks(mid treatment)

    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).

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

    Time frame: 6-8 weeks (mid treatment)

    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).

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

    Time frame: end of treatment (11-14 weeks)

    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).

Secondary outcomes

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

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

    This is a 7 item questionnaire, with a score range from 0-28, higher score indicating more insomnia

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

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

    9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher score indicating worse outcome

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

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

    This is a 6 item questionnaire and each is scored from 1(not at all) to 5(very much) for a maximum score of 30, higher score indicating more pain interference

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

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

    This is a 3 item questionnaire and each is scored from 1(had no pain) to 5(severe pain) for a maximum score of 15, higher score indicating more pain

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

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

    This is an 18 item questionnaire and each is scored from 1( totally disagree) to 5 (agree) for a maximum score of 90, higher score indicating better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Jackson, PhD

CONTACT

[email protected]

(281) 825-9923

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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