Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention - Randomized Controlled Trial (RCT)
Phase: NA
Conditions: Posttraumatic Stress Disorder, Tonic Immobility Response
Sponsor: Florida State University

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FLORIDA STATE UNIVERSITY
OFFICE of the VICE PRESIDENT for RESEARCH
          
APPROVAL
September 27, 2021
Danielle Morabito
dmorabito@fsu.edu
Dear Danielle Morabito:
On 9/27/2021, the IRB reviewed the following submission:
Type of Review:
Expedited
(4) Noninvasive procedures;
(7)(b) Social science methods
Title:
Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention – 
Randomized Controlled Trial (RCT)
Investigator:
Danielle Morabito
Submission ID:
MOD00001686
Study ID:
STUDY00002518
Funding:
None 
IND, IDE, or HDE:
None
Documents Reviewed:
• RCT Measures_updated 9.23.21.pdf, Category: 
Survey/Questionnaire/Instrument/Measure;
• TIP Script_Updated 9.23.21.pdf, Category: Protocol;
• TIP RCT Protocol, Category: IRB Protocol;
The IRB approved the modification, effective from 9/27/2021 .
COVID-19 Information for Research Involving Human Subjects: Note that the U.S. is 
operating under the national emergency Proclamation 9994 concerning the COVID-19 
pandemic and that this national emergency remains in effect until rescinded or terminated 
by the President of the U.S. (go here for the Proclamation letter). Conditions are dynamic 
and related policies or guidance evolve accordingly; as applicable, refer to the U.S. 
Centers for Disease Control and Prevention website specific for universities or refer to 
our COVID-19 and Human Research Studies web page to learn more about how you 

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should or may protect persons (whether vaccinated or unvaccinated) involved in any of 
your in-person research activities.
Other Information:
This study meets the definition of a clinical trial as it involves the assignment of one or 
more human subjects to one or more interventions (procedure, device, or drug, including 
use of placebo or control) to evaluate the effects of the interventions on biomedical or 
behavioral health outcomes. Please note that the approved IRB consent form template 
must be posted by the awardee to a federal website to be disclosed. This document must 
be posted after the research has been closed and no later than 60 days after the last study 
visit of any subject.
You are advised that any modification(s) to the protocol for this project must be reviewed 
and approved by the IRB prior to implementation of the proposed modification(s). 
Federal regulations require that the Principal Investigator promptly report any new 
information related to this protocol (see Investigator Manual (HRP-103)). 
In conducting this protocol, you are required to follow the requirements listed in the 
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library 
within the IRB system.
Sincerely,
Human Subjects Research Office
humansubjects@fsu.edu 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 1 of 19 
Revised: January 7, 2021 
 
 
PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention – Randomized Controlled Trial 
(RCT) 
 
PRINCIPAL INVESTIGATOR: 
Danielle Morabito 
Psychology 
850-645-1766 
morabito@psy.fsu.edu  
VERSION NUMBER/DATE: 1.2, 9/23/21 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
8/17/21 
Requested modifications to consent and 
protocol as detailed in the response letter. 
Yes 
2 
9/23/21 
Added study personnel; added 2 additional 
measures; revised TIP intervention script. 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ................................................................ 5 
6.0 
Procedures Involved* ............................................................................................... 5 
7.0 
Data and Specimen Banking* .................................................................................. 8 
8.0 
Sharing of Results with Subjects* ........................................................................... 9 
9.0 
Study Timelines* ..................................................................................................... 9 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 9 
11.0 Vulnerable Populations* ........................................................................................ 10 
12.0 Local Number of Subjects ..................................................................................... 10 
13.0 Recruitment Methods ............................................................................................. 10 
14.0 Withdrawal of Subjects* ........................................................................................ 12 
15.0 Risks to Subjects* .................................................................................................. 12 
16.0 Potential Benefits to Subjects* .............................................................................. 13 
17.0 Data Management* and Confidentiality ................................................................ 14 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 15 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 15 
20.0 Compensation for Research-Related Injury ........................................................... 16 
21.0 Economic Burden to Subjects ................................................................................ 16 
22.0 Consent Process ..................................................................................................... 16 
23.0 Process to Document Consent in Writing .............................................................. 17 
24.0 Setting .................................................................................................................... 17 
25.0 Resources Available ............................................................................................... 18 
26.0 Multi-Site Research* ............................................................................................. 18 
 
 
 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
1.0 
Study Summary 
 
Study Title 
Development and Evaluation of a Tonic Immobility Focused 
Psychoeducational Intervention - RCT 
Study Design 
Randomized Controlled Trial  
Primary Objective 
To evaluate the efficacy of a brief-web-based intervention 
(Tonic Immobility Psychoeducation; TIP) intended to 
educate about tonic immobility (TI) within a sample of those 
who experienced TI in the context of a traumatic event.  
Secondary 
Objective(s) 
(1) TIP will significantly reduce feelings of posttraumatic 
feelings of guilt and shame compared to control (2) TIP will 
significantly reduce PTSD symptoms across time relative to 
control (3) Reduction in trauma-related guilt and shame will 
mediate the association between condition and changed in 
PTSD symptoms at follow-up.  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Tonic Immobility Psychoeducation  
Health Education Training 
IND/IDE #  
 
Study Population 
Adults who endorse prior TI during a traumatic event and 
elevated PTSD symptoms 
Sample Size 
120 
Study Duration for 
individual 
participants 
1 month 
Study Specific 
Abbreviations/ 
Definitions  
TI = Tonic Immobility 
TIP = Tonic Immobility Psychoeducation 
HET = Health Education Training  
PTSD = Posttraumatic Stress Disorder  
 
 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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2.0 
Objectives* 
2.1 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. 
2.2 It is hypothesized that the TIP intervention will show benefits in a 
sample of those who have experienced a traumatic event. 
Specifically, we hypothesize that: TIP will significantly reduce 
feelings of posttraumatic feelings of guilt and shame compared to 
control; TIP will significantly reduce PTSD symptoms across time 
relative to control; reduction in trauma-related guilt and shame will 
mediate the association between condition and changed in PTSD 
symptoms at follow-up. 
3.0 
Background* 
3.1 Tonic Immobility (TI) is a common defensive response in situations 
involving extreme fear such as physical and sexual assault, and its 
occurrence is influenced by both situational and individual 
difference factors. Previous research has estimated the prevalence of 
TI among sexual assault survivors to be between 37 to 70% (Fusé et 
al., 2007; Galliano et al., 1993; Heidt et al., 2005; Möller et al., 
2017). Additional research among urban violence victims and 
anecdotal reports from combat veterans suggest similar experiences 
among these groups (Gallup & Rager, 1996; Solomon & 
Mukulincer, 2006; Fiszman et al., 2008). Although TI is adaptive in 
certain circumstances, it has been shown to contribute to increases in 
negative emotion, particularly guilt and shame, along with 
posttraumatic stress disorder (PTSD) symptoms. Moreover, several 
studies have demonstrated an association between TI and poorer 
recovery from PTSD (Fiszman et al., 2007; Lima et al., 2010; 
Hagenaars & Hagenaars, 2020). 
3.2 Among other cognitive-behavioral techniques, experts in the field of 
posttraumatic stress emphasize the importance of psychoeducation 
about common reactions during and after trauma exposure (Foa & 
Rothbaum, 2001; Herbert & Sageman, 2004; Resick et al., 2017). 
However, neither brief psychoeducational interventions nor the 
current frontline treatments for PTSD, have focused significant 
attention on the experience of TI (Foa et al., 2007; Resick et al., 
2017). Thus, the interpretation of TI during a traumatic event and the 
potentially detrimental changes in cognition, emotion, and behavior 
that result from it, are not directly addressed in any of the current 
empirically informed intervention protocols. Therefore, the current 
study aims to evaluate the effects of a brief TI-focused 
psychoeducation intervention on negative emotions, cognitions, and 
PTSD symptoms. 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
3.3 The framework of this intervention was modeled after 
psychoeducation paradigms used in previous research and found to 
be effective (e.g. anxiety sensitivity focused psychoeducation 
intervention; Schmidt et al., 2014). 
4.0 
Study Endpoints* 
4.1 Recruitment will stop after enrolling 120 participants. Data 
collection will continue until all enrolled participants have 
completed their Month 1 follow-up appointment, at which point data 
will be prepared for analysis 
4.2 This is a minimal risk study. There are no safety endpoints given that 
there are no safety risks associated with the study. 
5.0 
Study Intervention/Investigational Agent 
5.1 Tonic Immobility Psychoeducation (TIP; Active Condition) 
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. 
Health Education Training (HET; Control Condition) 
The Healthy Education Training intervention was developed as a 30-
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.  
6.0 
Procedures Involved* 
6.1 The study adheres to a randomized controlled trial (RCT) design. 
Participants will be randomized to either the TIP or HET condition. 
Randomization will be stratified based on undergraduate vs. 
community member status. For each group, a random number table 
will be generated in Excel with either 1 = TIP or 2 = HET assigned 
to each participant ID. After completion of consent, the participant 
will receive their ID (assigned in sequential order) and the research 
assistant will prepare the corresponding treatment.  

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
6.2 The study proposes to enroll 120 participants to test the efficacy of 
the TIP intervention, compared to a HET control condition. All data 
collection will be conducted using Qualtrics. The study will be 
comprised of a total of three time points: Baseline, Week 1 follow-
up, and Month 1 follow-up.  
First, eligible participants will read and sign an informed consent 
that outlines all study procedures, details limits to confidentiality, 
and emphasizes that participants may discontinue participation at 
any time with no penalty.  
The first appointment, baseline, will include pre-intervention self-
report measures, the completion of one of the two interventions (TIP 
or PHET), and post-intervention self-report measures. The baseline 
appointment is expected to take 90 minutes. Participants will be 
compensated with a $30 gift card or 1.5 course credits. All baseline 
procedures will be conducted either in-person within the Anxiety and 
Behavioral Health Clinic research suite or virtually via HIPAA-
compliant Zoom. For in-person sessions, all COVID-19 related 
federal, state, and local guidelines as well as FSU IRB regulations 
will be followed. See section 6.3 for further information on COVID-
19 safeguards. 
The second and third appointments, week 1 and month 1 follow-up, 
will be completed online. Participants will be contacted via email 
and asked to complete a battery of self-report measures via a 
Qualtrics survey link. The questionnaire is expected to last 30 
minutes and participants will be compensated either a $10 gift card 
of 0.5 course credits for the completion of each appointment. 
After the completion of the month 1 follow-up appointment, 
participants will be debriefed and individuals in the control condition 
will be given the opportunity to receive the active treatment 
condition.  
6.3 The risks to human subjects in the proposed study are minimal. 
Nevertheless, precautions will be taken to minimize participants’ risk 
in the proposed study. All individuals will be informed of the nature 
of the investigation and the types of assessments and procedures. 
Participants will be asked to fill out an informed consent statement 
prior to participating in the project. Should a participant experience 
emotional distress including strong emotional or physical reactions 
to the intervention, a graduate-level therapist supervised by Dr. 
Norman B. Schmidt will be called in to meet with the participant. 
Therapists will assist the participant in implementing coping skills to 
tolerate and reduce distress (e.g., deep breathing, self-soothing). Dr. 
Norman B. Schmidt or an alternate clinical supervisor with the FSU 
Psychology Clinic will be on call for consultation as needed at all 
times. 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
6.4 Safeguards for Protecting Against COVID-19. To reduce risk of 
COVID-19, our study team plans to follow standard COVID-19 
precautions such as social distancing, mask wearing, and the 
sanitization of surfaces. However, participants will be informed that 
the voluntary disclosure of their full COVID-19 vaccination status is 
an alternative to COVID-19 related precautions, and they would be 
able to remove their masks during the baseline appointment. Staff 
will make a note in the study log of who has shown full COVID-19 
vaccination documentation. The dialogue below will be said to 
participants when telling them about vaccination procedures: 
• “In order to protect against COVID-19 or Coronavirus, if 
you come to the lab we will follow certain precautions 
including social distancing and use of masks. However, we 
don’t have to do this for persons who have completed a full 
COVID-19 vaccination. You may, if you’d like, share with 
us information about your COVID-19 vaccination, but this 
is your decision and is not required. You can still come to 
the lab and we will follow our usual COVID-19 
precautions.” 
6.5 The following self-report measures will be used throughout the 
study.  
Demographic survey. A self-report questionnaire will be used to assess  
participant demographic information. Specifically, various demographic  
variables will be assessed including gender, ethnicity, race, sexual  
orientation, and educational/occupational level.  
 
Adverse Childhood Experiences Questionnaire. (ACE; Felitti et al., 
1998) The ACE is a self-report measure designed to assess abuse, neglect, 
and caregiver dysfunction experienced during childhood (i.e. before the 
age of 18). Participants were asked to respond “yes” or “no” to 10-items 
representing different categories of adverse childhood experiences.  
 
 
 
 
 
Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007). The ASI-3 is an  
18-item self-report questionnaire assessing levels of anxiety sensitivity.  
The ASI-3 is a widely used measure of fear of anxiety-related symptoms  
and sensations.  
 
Childhood Harshness & Unpredictability (Maranges et al., Under 
Review). A brief self-report measure will be used to assess perceptions of 
harshness and unpredictability during childhood. 
 
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 
2000). The CEQ is a 6-item self-report measure of client’s perceived 
expectations regarding the extent to which a treatment will reduce their 
symptoms.  

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Life Events Checklist (LEC-5; Weathers et al., 2013). The LEC-5  
assesses the number and specific type of traumatic experiences an 
individual has experienced in their lifetime, as defined by Criterion A of 
the PTSD section of the DSM-5. 
 
Positive and Negative Affect Schedule (PANAS; Watson et al., 1988). 
The PANAS is a 20-item self-report questionnaire assessing levels of 
positive and negative affect.  
 
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers 
et al., 2013). The PCL-5 is a 20-item self-report questionnaire used to 
assess PTSD symptoms.  
 
Posttraumatic Cognitions Inventory (PTCI; Foa et al., 1999). The 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.  
 
Scale for Tonic Immobility Occurring Post-trauma (STOP; Lloyd et 
al., 2019). The STOP is a 30-item self-report questionnaire designed to 
assess TI experiences occurring post-trauma.  
 
State Shame and Guilt Scale – 8 (SSGS-8; Cavalera et al., 2017). The 
SSGS-8 is a short version of the state shame and guilt scale designed to 
assess shame and guilt. This measure will be modified for the present 
study and participants will be asked to focus on their TI experience.  
 
Tonic Immobility Questionnaire (TIQ; Taylor et al., 2007). The TIQ is a  
12-item self-report questionnaire designed to assess TI experienced across  
a range of traumatic events. 
 
World Health Organization Disability Assessment Schedule 2.0 
(WHODAS 2.0; Ustun, T.B. & World Health Organization, 2010). The 
WHODAS 2.0 is an assessment of difficulties due to health conditions in 
social, occupational, and daily life domains. A short version (21 items) of 
the WHODAS was compiled utilizing subscales that are relevant to mental 
health. 
6.6 What data will be collected during the study and how that data will 
be obtained. 
Data from self-report measures will be collected online using 
Qualtrics which is a safe and secure survey website platform 
previously used by Florida State University. Data will be coded and 
stored on a password-protected file.  
7.0 
Data and Specimen Banking* 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
7.1 If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens. 
All data that will be used for analysis. Safeguards include: (a) 
ensuring that all project staff and participants are well informed 
about regulations pertaining to confidentiality, (b) the use of study 
ID numbers as opposed to names on all data forms, (c) requiring that 
all subject files be password protected if online, and (d) any paper 
copies will be stored in locked file cabinets. All study personnel will 
have access to stored data. 
7.2 List the data to be stored or associated with each specimen. 
Data will include de-identified study ID numbers, self-report data, 
and qualitative written responses to open ended questions. 
7.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
N/A 
8.0 
Sharing of Results with Subjects* 
8.1 Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how the results 
will be shared. 
N/A 
9.0 
Study Timelines* 
9.1 Participation is expected to last 1 month. We anticipate that it will 
take about 18 months to enroll all participants  
10.0 Inclusion and Exclusion Criteria* 
10.1 Student participants who endorse prior TI experience during the 
subject pool screening process will be invited to complete a 
Qualtrics survey to determine eligibility. Interested participants will 
be asked to sign-up for the current study using the Sona-systems 
website. Community participants will be directed to the Qualtrics 
survey through flyers and online advertisements. Eligible community 
participants will be contacted via phone to schedule their initial 
appointment.  
10.2 Eligible participants must be 18 years or older and have endorsed 
prior TI experience. Study participants will be selected for the 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
current investigation based on prior TI experience (TIQ items A & 
B) and elevated posttraumatic stress symptoms (PCL-5). Exclusion 
criteria includes individuals who have not endorsed past TI behavior 
and are not 18 years or older.  
10.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the 
above populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 
• 
Adults unable to consent: Excluded 
• 
Individuals who are not yet adult: Excluded 
• 
Pregnant women: Excluded 
• 
Prisoners: Excluded 
11.0 Vulnerable Populations* 
11.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
The current study will not involve pregnant women, prisoners, 
individuals under 18 years old, or cognitively impaired.  
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally. 
120 participants will be enrolled from Florida State University and 
the Tallahassee, FL area. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be recruited. 
If recruitment will involve a non-FSU site, describe whether site 
approval for recruitment is required, and attach documentation of 
site approval.  
Participants will be recruited from the FSU undergraduate subject 
pool and the Tallahassee community. Student participants will be 
recruited from the psychology undergraduate research pool. 
Community participants will be recruited via online advertisements.  
13.2 Describe the source of subjects. 
All participants will be recruited from Florida State University and 
Tallahassee, FL.  
13.3 Describe the methods that will be used to identify potential subjects. 
Individuals will be identified as potential participants if they are 18 
years or older and have endorsed past TI experience. Potential 
student participants who endorse prior TI experience during the 
subject pool screening process will be invited to complete a 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
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Qualtrics survey to determine eligibility. Community participants 
will be directed to the Qualtrics survey to determine eligibility. 
Eligible participants will then be contacted via phone to schedule 
their initial appointment. 
13.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Recruitment methods include flyers posted in the community and 
online advertisements via social media platforms (e.g. Facebook, 
twitter).  
13.5 Describe as applicable whether and how subjects will be paid, earn 
course or other credits, reimbursed or provided with any financial or 
other incentive, token or gift for taking part in the research. Include 
a description and schedule of the total amount or value as well as 
the timing of any payments, credits, reimbursement or other 
incentive, token or gift. Indicate how if at all any amount is pro-
rated for research visit or activity completion, and whether and how 
subjects’ refusal to answer any question or subjects’ withdrawal 
from or discontinuing taking part in the study or any study activity 
will reduce or preclude subjects from earning part or all of such any 
payment, credit, reimbursement or other incentive, token or gift. 
Also describe the proposed method (how, by whom, form etc.) of 
payment/disbursement. While payment should not be contingent 
upon completion of the entire study, a proportion or progressive 
partial payment as an incentive for completion of the study is 
acceptable. 
Student participants will receive 1.5 course credits for completion of 
the baseline appointment and 0.5 credits for each follow-up 
appointment. Thus, participants will receive 2.5 credits in total for 
completing all study appointments. Participants who refuse to 
answer any question or withdraw from the study will still receive 
compensation for their appointment.   
Community participants will receive a $30 gift card for completion 
of the baseline appointment and a $10 gift card for each follow-up 
appointment. Thus, participants will receive $50 in total for 
completing all study appointments. Participants who refuse to 
answer any question or withdraw from the study will still receive 
compensation for their appointment.   
 

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Focused Psychoeducational Intervention - RCT 
 
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14.0 Withdrawal of Subjects* 
14.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Possible reasons for removal include failure to complete the TIP 
intervention or self-report measures.  
14.2 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
The participant will be told the can leave the research at any time 
and it will not be held against them. All data collected prior to 
withdrawal will be securely stored and analyzed unless otherwise 
requested. Participants will be able to contact the PI to request the 
removal of their data, if so desired. 
 
15.0 Risks to Subjects* 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. For each of these risks, describe in detail how the 
risks will be minimized. 
The risks to human subjects in the proposed study are minimal. 
Nevertheless, precautions will be taken to minimize participants’ risk 
in the proposed study. All individuals will be informed of the nature 
of the investigation and the types of assessments and procedures. 
Participants will be asked to sign an informed consent statement 
prior to participating in the project. The specific potential risks 
involved in the proposed investigation are enumerated below:  
Self-report measures 
It is unlikely that participants will be at risk for emotional or 
physical harm as a result of study participation. However, there is a 
slight possibility that participants may experience emotional 
discomfort or distress while completing study tasks. Based upon our 
past research, any distress reactions due to completion of 
questionnaires is typically acute (i.e., few minutes in duration) and 
relatively minor.   
Interventions 
HET has been used in prior research studies with no adverse effects. 
Content is related to healthy living and stress management, and not 
expected to cause distress. 

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Focused Psychoeducational Intervention - RCT 
 
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TIP has been modeled after a previous intervention which has been 
used in several studies and has a high level of acceptability as well as 
gold-standard evidence-based treatments for trauma. Although the 
information presented in the training should be no more anxiety-
provoking than situations experienced in day-to-day life, it is 
possible that some participants may have strong emotional or 
physical reactions to information covered in the intervention. 
However, we believe prolonged distress is unlikely and feel that 
most participants will derive benefit from the interventions.  
Protections against risk  
Confidentiality will be described during the consent process. The 
process will reiterate the limits of confidentiality. Data entry 
personnel will download the data into a dedicated, password-
protected computer database as an additional on-site back-up. 
Computer files will be maintained on the servers and backed up 
daily. Computers and databases will be password protected with 
independent passwords known only to the PI and data entry 
personnel. All data will be accessible only to trained study staff. 
Participants’ data will be de-identified and coded with ID numbers. 
A link between participant names and ID numbers will be kept 
separately in a password protected computer file. All project staff are 
trained and certified in HIPAA regulations, responsible conduct of 
research and the protection of human research subjects via 
Collaborative Institutional Training Initiative (CITI) courses. 
The risk of emotional discomfort will be minimized by informing 
participants that they are allowed to skip any sensitive areas on the 
assessment measure and may discontinue participation at any time. 
All research staff will be trained to deal with sensitive clinical issues 
and will be available should participants need assistance.  
Further, a trained graduate-level therapist, supervised by Licensed 
Clinical Psychologist Norman B. Schmidt, will be available to assist 
participants experiencing emotional discomfort, including strong 
emotional or physical reactions to intervention materials, at all times. 
Standard procedures include implementation of coping skills (e.g., 
deep breathing, self-soothing) to reduce distress and referral to 
treatment, if desired. Dr. Noman B. Schmidt or an alternate clinical 
supervisor within the FSU Psychology Clinic will be on call and 
available during study sessions if consultation is needed.  
15.2 – 15.4  
 
N/A  
16.0 Potential Benefits to Subjects* 
16.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 

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Focused Psychoeducational Intervention - RCT 
 
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Revised: January 7, 2021 
 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
The primary benefits to participants include possible improvements 
to mental health.  
16.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others.  
N/A 
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis. 
Preliminary analyses and data screening will be conducted prior to 
the primary analyses. This will include checking equivalence of 
random assignment to treatment condition based on key baseline 
characteristics. Specifically, analyses will be conducted to ensure 
that there are not baseline differences between condition (active vs. 
control) in terms of age, gender, and TIQ total scores.  
Hierarchical linear regression analyses will be conducted to examine 
the impact of intervention condition on early treatment outcomes 
including posttreatment guilt, posttreatment shame, and week 1 
PTSD symptoms. Analyses will be conducted in SPSS version 27.0. 
Latent difference score analyses will be utilized to examine the 
differential change in guilt, shame, and PTSD symptoms between 
intervention conditions, across all study timepoints. Analyses will be 
conducted in Mplus version 8.0 (Muthén & Muthén, 1998-2017). 
Full information maximum likelihood (FIML) with the adjusted 
Yuan-Bentler scaled chi-square index (Y-B χ2) will be utilized when 
possible in order to account for missing data. To determine model fit, 
the S-B χ2 statistic as well as several indices will be used. 
Three separate models will be estimated for the impact of treatment 
condition on guilt, shame, and PTSD symptoms. The effects of 
treatment condition on changes in guilt from pre-intervention to 
post-intervention (change 1), from post-intervention to week 1 
(change 2), and from week 1 to month 1 (change 3) will be examined 
using a multi-group latent difference score (LDS) approach (Mun et 
al., 2009). The same methods will be used to examine effects of 
treatment condition on shame from pre-intervention to post-
intervention (change 1), from post-intervention to week 1 (change 2), 
and from week 1 to month 1 (change 3) and PTSD symptoms from 
pre-intervention to week 1 (change 1), and from week 1 to month 1 
(change 2). 
The indirect effects of treatment condition on PCL-5 scores at month 
1 through week 1 guilt and shame will be examined in two separate 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 15 of 19 
Revised: January 7, 2021 
 
mediation models. Maximum likelihood and percentile bootstrapped 
CIs (with 5,000 resamples) will be used (Hayes & Scharkow, 2013; 
Preacher & Hayes, 2004). 
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
All data will be coded by arbitrary participant numbers to ensure 
confidentiality and will be stored using password protected 
documents. Specifically, once the participant is consented, they will 
be assigned a unique study ID, which will be used instead of their 
name on subsequent surveys. The document linking participant 
names to study IDs will be recorded in a password-protected 
Microsoft Excel document, which will be stored on a password-
protected server inside the Anxiety and Behavioral Health Clinic 
(ABHC) research suite. Only ABHC study staff (i.e., PI, graduate 
students, and project coordinators) who have been trained in data 
management procedures will be able to access the data via password.  
17.3 Describe any procedures that will be used for quality control of 
collected data. 
See 17.4  
17.4 Describe how data or specimens will be handled study-wide: 
Data entry personnel will download the data into a dedicated, 
password-protected computer database. Computer files will be 
maintained on the servers and backed up daily. Computers and 
databases will be password protected with independent passwords 
known only to the PI and data entry personnel. Other safeguards 
include: (a) ensuring that all project staff are well informed about 
regulations pertaining to confidentiality, (b) the use of ID numbers as 
opposed to names on all data forms, (c) utilizing computer-based 
assessments whenever possible. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
This section is required when research involves more than Minimal Risk 
to subjects. 
N/A 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 16 of 19 
Revised: January 7, 2021 
 
All self-report data will be collected via Qualtrics, which is a secure 
website used by FSU to collect questionnaire data. Qualtrics data 
will be labeled only with participant IDs to ensure confidentiality. 
Data will be electronically communicated through password 
protected emails and password protected documents. 
19.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
Study participants will be able to withdraw from participation at any 
point without penalty. Any distress that a participant may feel is 
expected to be brief in duration (i.e., few minutes). In addition, 
should any lasting feelings of distress arise from an individual’s 
participation, study participants are encouraged to contact the study 
PI. Each prospective participant will be notified through the consent 
that identifying information will not be tied to survey responses, 
except for the signed consent form. 
19.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
All research staff team will have access to password protected 
documents. 
20.0 Compensation for Research-Related Injury 
20.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury. 
N/A 
20.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
N/A 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
N/A 
22.0 Consent Process 
22.1 Indicate whether you will you be obtaining consent, and if so 
describe: 
This study will follow SOP: Informed Consent Process for Research 
HRP-090. The consent process will take place in-person in our 
research lab or via Zoom for participants taking part in the study 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 17 of 19 
Revised: January 7, 2021 
 
online. In the case of online participation, subjects will be asked to 
provide an electronic signature in place of their hand-written 
signature. 
Non-English Speaking Subjects - N/A 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) - N/A 
Subjects who are not yet adults (infants, children, teenagers) - N/A 
Cognitively Impaired Adults - N/A 
Adults Unable to Consent - N/A 
23.0 Process to Document Consent in Writing 
23.1 Describe whether you will be following “SOP: Written 
Documentation of Consent (HRP-091).” If not, describe whether and 
how consent of the subject will be documented in writing. 
This study will be following SOP: Informed Consent Process for 
Research HRP-091. 
23.2 If your research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written 
documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to 
obtain written documentation of consent. 
N/A 
23.3 (If you will document consent in writing, attach a consent document. 
If you will obtain consent, but not document consent in writing, 
attach a consent script. Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have 
provided sufficient information. You may use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent 
document or script.) 
See attached consent form.  
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
The research team will identify and recruit potential subjects from 
the FSU psychology undergraduate research pool and Tallahassee 
community. The research study will take place in person or online 
via HIPAA compliant Zoom. For in-person appointments, measures 
will be taken to safeguard against COVID-19 (e.g., social distancing, 
mask wearing, thoroughly cleaning surfaces). 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 18 of 19 
Revised: January 7, 2021 
 
25.0 Resources Available 
25.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
• 
Justify the feasibility of recruiting the required number of 
suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? 
What percentage of those potential subjects do you need to 
recruit? 
There are approximately 1,500 students screened through the  
undergraduate psychology research pool in 1 year and 159,426 
people in the Tallahassee area. Thus, recruitment for our 
sample size (N = 120) is highly feasible. 
 
• 
Describe the time that you will devote to conducting and 
completing the research. 
 
We anticipate completing the research study in 18 months. 
 
• 
Describe your facilities. 
Our research suite includes four individual, private research rooms that 
each contain a password protected computer and locked file cabinets. 
The research suite is locked via swipe access that only research staff 
have access to.  
• 
Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research. 
 
Although the study is expected to cause no more than minimal 
distress, a resource sheet will be provided to participants with 
local emergency & referral numbers. 
 
• 
Describe your process to ensure that all persons assisting with 
the research are adequately informed about the protocol, the 
research procedures, and their duties and functions. 
 
All research staff are given protocols that outline duties for 
each job that is part of the study. These protocols are available 
on an online computer drive which staff members have access 
to. 
 
26.0 Multi-Site Research* 
N/A 
 

PROTOCOL TITLE: Development and Evaluation of a Tonic Immobility 
Focused Psychoeducational Intervention - RCT 
 
Page 19 of 19 
Revised: January 7, 2021 
 
 

Permission to Take Part in a Human Research Study 
 
 
 
 
Page 1 of 4 
Title of research study:  Development and Evaluation of a Tonic Immobility Focused 
Psychoeducational Intervention – Randomized Controlled Trial (RCT) 
Investigator: Danielle M. Morabito 
Key Information: The following is a short summary of this study to help you decide whether or 
not to be a part of this study. More detailed information is listed later on in this form. 
• Consent is being sought for research for the study described in detail below, participation in 
which is completely voluntary. 
• The purpose of this research is to examine whether a brief web-based intervention reduces 
negative thoughts, feelings, and symptoms associated with trauma. 
• Duration of participation is expected to be no longer than 1 month, during which time 
participants will complete an initial appointment consisting of a brief online intervention and 
self-report measures, as self-report measures at 1-week and 1-month follow-ups after the initial 
appointment. The initial session will be conducted either in-person or via HIPAA compliant 
Zoom. The follow-ups can be completed online through Qualtrics survey software. 
• While we think one intervention condition will reduce trauma-related symptoms, we do not 
think that the second will. We do not know and cannot guarantee whether you will receive the 
active intervention. You will be randomized based on student status and participant ID# to 
complete one of these two interventions. There is a 50/50 chance that you will receive the 
active intervention.  
• Potential risks include feelings of discomfort when answering self-report measures and the 
possibility of an unexpected breach in confidentiality. 
• Potential benefits include improvement in mental health. 
• If you did not receive the intervention that we think will improve symptoms during the first 
appointment, it will be offered to you after the 1-month follow-up is complete. 
• Total compensation for completion of all parts of the study is 2.5 course credits (for 
undergraduate students enrolled through the subject pool) or $50 in gift cards. 
Why am I being invited to take part in a research study? 
We invite you to take part in a research study because you endorsed a previous experience where you 
felt frozen or paralyzed with fear.  
What should I know about a research study? 
• Someone will explain this research study to you. 
• Whether or not you take part is up to you. 
• You can choose not to take part. 
• You can agree to take part and later change your mind. 
• Your decision will not be held against you. 
• You can ask all the questions you want before you decide. 

Permission to Take Part in a Human Research Study 
 
Page 2 of 4 
Why is this research being done? 
The purpose of this study is to examine whether a brief web-based intervention reduces negative 
thoughts, feelings, and symptoms associated with trauma. 
How long will the research last and what will I need to do? 
We expect that you will be in this research study for 1 month. The initial appointment will take 
approximately 1.5 hours and you will be compensated with either a) 1.5 course credits (for 
undergraduate students enrolled through the subject pool) or b) a $30 gift card. You will be asked to 
complete self-report measures before completing the intervention. After completing the intervention, 
you will be asked to complete more self-report measures. Additionally, you will receive surveys to 
complete at 1-week and 1-month after the initial appointment. We expect these surveys to take 
approximately 30 minutes each. You will be compensated with 0.5 credits or $10 gift card for each of 
these surveys. 
More detailed information about the study procedures can be found under “What happens if I say yes, 
I want to be in this research?” 
Is there any way being in this study could be bad for me? 
If you choose to take part in this study, there is a risk of feeling uncomfortable, frustrated, tired, or 
upset while answering the questionnaires. You do not have to answer any question that makes you 
uncomfortable, and you may stop your participation at any time.  
Although the information presented in the training should be no more anxiety-provoking than 
situations experienced in day-to-day life (e.g., watching the news), some individuals may experience 
strong emotional or physical reactions. In the event that you experience any strong emotional or 
physical reactions, a trained graduate-level therapist, supervised by Licensed Clinical Psychologist Dr. 
Norman B Schmidt, will be available to assist you.  
Although efforts are made to protect your research study records, there is always a risk that someone 
could get access to the personal information in your medical records or other information researchers 
have stored about you. There may also be other risks of taking part in this study that we do not yet 
know about. 
More detailed information about the risks of this study can be found under “Is there any way being in 
this study could be bad for me? (Detailed Risks)” 
Safeguards against COVID-19:  
For in-person study activities, we are required to follow certain COVID-19 precaution such as social 
distancing and the use of masks. However, we do not have to do this for persons who have completed a 
full COVID-19 vaccination. You may voluntarily share with us this information about your COVID-19 
vaccination, but this is your decision and is not required. If you do share this information with us, we 
will make a note of it in our records.  
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits include possible improvements to mental health. Others may benefit in the future 
from the information learned during this study.  
What happens if I do not want to be in this research? 
Participation in research is completely voluntary. You can decide to participate or not to participate. 

Permission to Take Part in a Human Research Study 
 
Page 3 of 4 
If you are a part of the undergraduate psychology subject pool and choose not to participate, you may 
enroll in different research studies and/or complete an alternative assignment to earn course credit. 
You are encouraged to discuss these options with your course instructor.  
There are other options for managing symptoms associated with a traumatic experience. Alternative 
treatments and/or procedures that may be available to you include: psychotherapy and/or medication 
offered outside of this study. A list of some potential resources/providers in the area will be provided 
to you. You should also talk with your personal physician (if applicable) about these options.  
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, please contact Dr. 
Norman B. Schmidt at (850) 644-1707 or the principal investigator Danielle Morabito at (973)907-
3914 or morabito@psy.fsu.edu  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may 
talk to them at 850-644-7900 or humansubjects@fsu.edu if: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
How many people will be studied? 
We expect about 120 people here will be in this research study out of 120 people in the entire study 
nationally.  
What happens if I say “yes” to being in this research? 
We expect that you will be in this research study for 1 month. The initial appointment will take 
approximately 1.5 hours and you will be compensated with either a) 1.5 course credits (for 
undergraduate students enrolled through the subject pool) or b) a $30 gift card. After completing this 
consent form, you will receive a participant ID# which corresponds to one of the two treatment 
conditions (randomly assigned prior to participation). There is a 50/50 chance that you will receive the 
active treatment. You will be asked to complete self-report measures before completing the 
intervention. After completing the intervention, you will be asked to complete more self-report 
measures. Additionally, you will receive surveys to complete online using Qualtrics Survey Software 
at 1-week and 1-month after the initial appointment. The survey links will be sent to you via email. We 
expect these surveys to take approximately 30 minutes each. You will be compensated with 0.5 credits 
or $10 gift card for each of these surveys. 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to complete all self-report measures, your 
assigned intervention, and all follow-up appointments. 

Permission to Take Part in a Human Research Study 
 
Page 4 of 4 
What happens if I say “yes,” but I change my mind later? 
You can leave the research at any time it will not be held against you. 
Is there any way being in this study could be bad for me? (Detailed Risks) 
There is a risk of feeling uncomfortable, frustrated, tired, or upset while answering the questionnaires. 
You do not have to answer any question that makes you uncomfortable, and you may stop your 
participation at any time. Additionally, some information presented in the training may trigger strong 
emotional or physical reactions. There may also be other risks of taking part in this study that we do 
not yet know about. In addition to these risks, this research may hurt you in ways that are unknown.  
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including research 
study and medical records, to people who have a need to review this information. We cannot promise 
complete secrecy. Organizations that may inspect and copy your information include the IRB and other 
representatives of this organization. Records of your participation in this research study may only be 
disclosed in accordance with state and federal law, including the Federal Privacy Act, 5 U.S.C.552a, 
and its implementing regulations. 
Procedures to protect the confidentiality of the data in this study include but are not limited to: 
Assignment of a random numeric ID that will be linked to participants’ name only in a password-
protected file stored on a secure server. 
Researchers will make every effort to protect your privacy and confidentiality; however, there are risks 
of breach of information security and information loss.  
By signing this document, you give your permission for information gained from your participation in 
this research study to be published in literature, discussed for educational purposes, and used generally 
to further science. You will not be personally identified; all information will be presented as 
anonymous data.  
If identifiers are removed from your identifiable private information or identifiable samples that are 
collected during this research, that information or those samples could be used for future research 
studies or distributed to another investigator for future research studies without your additional 
informed consent. 
 
Signature Block for Capable Adult 
Your signature documents your permission to take part in this research. 
 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
 
 
Date 
 
 
Printed name of person obtaining consent