Posttraumatic Stress Disorder, Tonic Immobility Response
Conditions
Keywords
Psychoeducation, Online Intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTonic 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.
BEHAVIORALHealth 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).
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Endorsed prior TI experience (TIQ items A & B) * Elevated posttraumatic stress symptoms (PCL-5; Blevins et al., 2015)
Exclusion criteria
Inability to consent or complete the intervention including: * Cognitive impairment * Uncorrected visual or auditory impairment * Unmedicated severe mental illness * Imminent risk of harm to self or others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Symptoms | up to 1 month | 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. |
| Guilt | post-intervention, on Day 1 | 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. |
| Shame | post-intervention, on Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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). | 25 |
| Total | 51 |
Baseline characteristics
| Characteristic | Health Education Training (HET) | Total | Tonic Immobility Psychoeducation (TIP) |
|---|---|---|---|
| Age, Continuous | 21.48 years STANDARD_DEVIATION 5.85 | 22.59 years STANDARD_DEVIATION 7.57 | 23.65 years STANDARD_DEVIATION 8.9 |
| Anxiety Sensitivity Inventory 3 | 36.68 units on a scale STANDARD_DEVIATION 13.85 | 35.96 units on a scale STANDARD_DEVIATION 14.85 | 35.24 units on a scale STANDARD_DEVIATION 16.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 15 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 36 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Life Events Checklist for DSM-5 | 12.6 Number of items endorsed STANDARD_DEVIATION 5.33 | 13.20 Number of items endorsed STANDARD_DEVIATION 6.17 | 13.77 Number of items endorsed STANDARD_DEVIATION 6.94 |
| Negative Affect | 26.32 units on a scale STANDARD_DEVIATION 8.13 | 25.78 units on a scale STANDARD_DEVIATION 8.23 | 25.24 units on a scale STANDARD_DEVIATION 8.46 |
| Posttraumatic Cognitions Inventory | 111.38 units on a scale STANDARD_DEVIATION 36.63 | 119.44 units on a scale STANDARD_DEVIATION 38.3 | 126.50 units on a scale STANDARD_DEVIATION 39.09 |
| Posttraumatic Stress Checklist for DSM-5 | 46.6 units on a scale STANDARD_DEVIATION 16.04 | 49.27 units on a scale STANDARD_DEVIATION 15.19 | 51.85 units on a scale STANDARD_DEVIATION 14.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 40 Participants | 20 Participants |
| Region of Enrollment United States | 25 participants | 51 participants | 26 participants |
| Sex: Female, Male Female | 23 Participants | 47 Participants | 24 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
| State Guilt (State Shame Guilt Scale) | 8.40 units on a scale STANDARD_DEVIATION 4.75 | 9.47 units on a scale STANDARD_DEVIATION 4.96 | 10.50 units on a scale STANDARD_DEVIATION 5.03 |
| State Shame (State Shame Guilt Scale) | 9.36 units on a scale STANDARD_DEVIATION 4.83 | 9.51 units on a scale STANDARD_DEVIATION 4.65 | 9.65 units on a scale STANDARD_DEVIATION 4.57 |
| Tonic Immobility Questionnaire | 32.92 units on a scale STANDARD_DEVIATION 12.03 | 32.49 units on a scale STANDARD_DEVIATION 11.51 | 32.08 units on a scale STANDARD_DEVIATION 11.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
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.
Time frame: post-intervention, on Day 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Guilt | 6.6 units on a scale | Standard Deviation 2.94 |
| Health Education Training (HET) | Guilt | 6.85 units on a scale | Standard Deviation 3.86 |
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.
Time frame: up to 1 month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Posttraumatic Stress Disorder Symptoms | 30.41 units on a scale | Standard Deviation 18.23 |
| Health Education Training (HET) | Posttraumatic Stress Disorder Symptoms | 31.93 units on a scale | Standard Deviation 18.33 |
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.
Time frame: post-intervention, on Day 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tonic Immobility Psychoeducation (TIP) | Shame | 6.80 units on a scale | Standard Deviation 2.8 |
| Health Education Training (HET) | Shame | 6.7 units on a scale | Standard Deviation 3.76 |