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A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event.
A randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (TI) within a sample of those who experienced TI in the context of a traumatic event. The investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and PTSD symptoms as compared to an active control condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Experimental | Participants in the experimental condition will receive the TIP intervention. |
|
| Health Education Training (HET) | Placebo Comparator | Participants in the control condition will receive the HET intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Behavioral | TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments. |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder Symptoms | PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes. | up to 1 month |
| Guilt | Feelings of guilt as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes. | post-intervention, on Day 1 |
| Shame | Feelings of shame as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes. | post-intervention, on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Inability to consent or complete the intervention including:
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| Name | Affiliation | Role |
|---|---|---|
| Norman B Schmidt, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxiety and Behavioral Health Clinic | Tallahassee | Florida | 32306 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tonic Immobility Psychoeducation (TIP) | Participants in the experimental condition will receive the TIP intervention. Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments. |
| FG001 | Health Education Training (HET) | Participants in the control condition will receive the HET intervention. Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tonic Immobility Psychoeducation (TIP) | Participants in the experimental condition will receive the TIP intervention. Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posttraumatic Stress Disorder Symptoms | PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes. | The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience. | Posted | Mean | Standard Deviation | units on a scale | up to 1 month |
|
Adverse events were monitored throughout the duration of the study. Each participant was observed from baseline through contacts at baseline, one-week, and one-month follow-up.
No adverse events occurred during the course of the study, to the knowledge of the investigative team. No adverse events were reported by participants to the investigative team or IRB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tonic Immobility Psychoeducation (TIP) | Participants in the experimental condition will receive the TIP intervention. Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments. |
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Limitations of the study include small sample size and attrition.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle M. Morabito | Florida State University | 850) 645-1766 | morabito@psy.fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 27, 2021 | Dec 5, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D046353 | Immobility Response, Tonic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001522 | Behavior, Animal |
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Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
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The participant will be randomly assigned to the active or control condition. The participant will not be informed of which condition they are receiving until after completion of the study, at which point individuals in the control condition will be given access to the active intervention.
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| Health Education Training (HET) | Behavioral | The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms). |
|
| BG001 | Health Education Training (HET) | Participants in the control condition will receive the HET intervention. Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participants were instructed to "select all that apply". | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Posttraumatic Stress Checklist for DSM-5 | The posttraumatic stress checklist for DSM-5 (PCL-5) is a 20-item self report measure of posttraumatic stress symptoms. Items are rated from 0 to 4 and totaled for a score ranging between 0 and 80. Higher scores indicated worse symptoms. | Mean | Standard Deviation | units on a scale |
|
| State Shame (State Shame Guilt Scale) | The State Shame Guilt scale is an 8-item self-report questionnaire with two subscales: state shame and state guilt. Items are rated 1 to 5 and added for a total score of 4 to 20. Higher scores indicate more shame/guilt. | Mean | Standard Deviation | units on a scale |
|
| Posttraumatic Cognitions Inventory | The Posttraumatic Cognitions Inventory (PTCI) is a 33-item scale designed to assess negative cognitions about the self, negative cognitions about the world, and self-blame occurring post-trauma. Items are rated from 1 to 7 and added for a total score of 33 to 231. Higher scores indicate more problematic posttraumatic cognitions. | Mean | Standard Deviation | units on a scale |
|
| Negative Affect | Measured using the Positive and Negative Affect Scale, negative affect subscale (PANAS-NA). The PANAS-NA is a 10-item measure of negative affect. Items are rated on a scale form 1 to 5, and added for a total score of 10 to 50 with higher scores indicating more negative affect. | Mean | Standard Deviation | units on a scale |
|
| Anxiety Sensitivity Inventory 3 | The Anxiety Sensitivity Inventory 3 (ASI-3) is an 18 item self-report questionnaire used to measure fear of anxiety-related symptoms and sensations. Items are rates on a scale from 0 to 4 and added for a total score of 0 to 72, with higher scores indicating higher anxiety sensitivity. | Mean | Standard Deviation | units on a scale |
|
| Life Events Checklist for DSM-5 | The Life Events Checklist for DSM-5 (LEC-5) is a questionnaire intended to screen for 16 potentially traumatic events that an individual may have experienced, witnessed, and/or learned about in their lifetime. Total number of trauma types experienced, witnessed, and/or learned about is added for a "trauma load" total score ranging between 0 and 48. | Mean | Standard Deviation | Number of items endorsed |
|
| Tonic Immobility Questionnaire | The Tonic Immobility Questionnaire (TIQ) is a 12-item measures designed to assess tonic immobility experiences across a range of traumatic events. Items are rated on a scale of 0 to 4 for a total score of 0 to 48, with higher scores indicating more severe tonic immobility. | Mean | Standard Deviation | units on a scale |
|
| State Guilt (State Shame Guilt Scale) | The State Shame Guilt scale is an 8-item self-report questionnaire with two subscales: state shame and state guilt. Items are rated 1 to 5 and added for a total score of 4 to 20. Higher scores indicate more shame/guilt. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Health Education Training (HET) | Participants in the control condition will receive the HET intervention. Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms). |
|
|
| Primary | Guilt | Feelings of guilt as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes. | The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience. | Posted | Mean | Standard Deviation | units on a scale | post-intervention, on Day 1 |
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| Primary | Shame | Feelings of shame as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes. | The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience. | Posted | Mean | Standard Deviation | units on a scale | post-intervention, on Day 1 |
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Health Education Training (HET) | Participants in the control condition will receive the HET intervention. Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms). | 0 | 25 | 0 | 25 | 0 | 25 |
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| D001519 | Behavior |
| D009043 | Motor Activity |