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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorThe University of Texas Health Science Center, Houston

About this trial

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),

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: SIT NAVIGATOR plus Stress NAVIGATOR groupExperimental treatment 2 interventions
Group B: SIT NAVIGATOR only groupActive comparator 1 intervention

Trial outcomes

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)

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

Time frame
end of study (about 11-14 weeks after baseline)
2

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

Time frame
end of study (about 11-14 weeks after baseline)
3

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

Time frame
4 weeks after baseline
4

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

Time frame
8 weeks after baseline

Secondary outcomes

1

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

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

Time frame
Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
2

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

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

Time frame
Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
3

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

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

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

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

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

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

Other outcomes

Sponsors and contacts

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