Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)

Conditions
-----------------
Posttraumatic Stress Disorder, Tonic Immobility Response

Intervention / Treatment
-----------------
* Behavioral: Tonic Immobility Psychoeducation (TIP)
* Behavioral: Health Education Training (HET)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to complete 1 of 2 interventions - active or control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tonic Immobility Psychoeducation (TIP)<br>Participants in the experimental condition will receive the TIP intervention. | Behavioral: Tonic Immobility Psychoeducation (TIP)<br>* 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.<br>|
| Placebo Comparator: Health Education Training (HET)<br>Participants in the control condition will receive the HET intervention. | Behavioral: Health Education Training (HET)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Symptoms | PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5); Value range = 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. | up to 1 month | 
| 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. | up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychoeducation, Online Intervention