Evaluation of a Self-Monitoring Intervention to Reduce Safety Behaviors in Social Anxiety: A Randomized Controlled Trial
Phase: NA
Conditions: Social Anxiety
Sponsor: Florida State University

 
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Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social 
Anxiety 
 
NCT05168020 
 
11/24/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PROTOCOL TITLE: 
Text Message Safety Behavior Fading Intervention for Social Anxiety 
PRINCIPAL INVESTIGATOR: 
 
Nora Mueller 
 
mueller@psy.fsu.edu 
 
1107 W Call St 
 
Tallahassee, FL 32301 
 
VERSION NUMBER/DATE: 
 
 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
         
6/10/2021   
Change of Participant compensation 
Yes 
2 
8/24/2021 
Change in duration of Participant participation 
in study 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
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* .................................................................................. 7 
8.0 
Sharing of Results with Subjects* ........................................................................... 8 
9.0 
Study Timelines* ..................................................................................................... 8 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 8 
11.0 Vulnerable Populations* .......................................................................................... 8 
12.0 Local Number of Subjects ....................................................................................... 8 
13.0 Recruitment Methods ............................................................................................... 8 
14.0 Withdrawal of Subjects* .......................................................................................... 9 
15.0 Risks to Subjects* .................................................................................................... 9 
16.0 Potential Benefits to Subjects* .............................................................................. 10 
17.0 Data Management* and Confidentiality ................................................................ 11 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 11 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
20.0 Compensation for Research-Related Injury ........................................................... 12 
21.0 Economic Burden to Subjects ................................................................................ 12 
22.0 Consent Process ..................................................................................................... 12 
23.0 Process to Document Consent in Writing .............................................................. 12 
24.0 Setting .................................................................................................................... 12 
25.0 Resources Available ............................................................................................... 12 
26.0 Multi-Site Research* .............................................. Error! Bookmark not defined. 
 
 
 

 
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1.0 
Study Summary 
 
Study Title 
Safety Behavior Fading Intervention for Social Anxiety 
Study Design 
Randomized Control Trial 
Primary Objective 
To investigate the efficacy of a text message based safety 
behavior fading paradigm. 
Secondary 
Objective(s) 
Explore the effect of safety behavior fading on: 
1) Levels of emotional disclosure. 
2) Reductions in levels of perceived loneliness.  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
1) A control condition where participants are asked to 
participate in healthy behaviors 
2) A safety behavior fading condition in which participants 
receive reminders to change their behavior. 
Study Population 
Adults aged 18-65  
Sample Size 
500 
Study Duration for 
individual 
participants 
Approximately 4 hours across a 4 week period. 
Study Specific 
Abbreviations/ 
Definitions  
 
 
 
2.0 
Objectives* 
2.1 The current study aims to explore the efficacy of a text message 
based Safety Behavior Fading Intervention compared to a control 
intervention. 
2.2 We hypothesize that individuals practicing safety behavior fading 
will exhibit (1) decreased social anxiety symptoms and report (2) 
increased levels of emotional disclosure, and (3) greater reductions 
of perceived loneliness compared to the  control group. 
 
3.0 
Background* 
3.1 Safety behaviors are defined as behavioral strategies deemed 
necessary for preventing or minimizing a feared outcome. 
Theoretical models suggest that excessive use of safety behaviors 
may serve a casual and/or maintaining role among a range of 
psychopathology, including social anxiety disorder (Well et al., 
1995), a disorder characterized by an intense fear of being judged or 
negatively evaluated by others, or rejected in a social or 
performance situation.. While social anxiety disorder causes both 
distressing and impairing symptoms, studies have begun to show a 
link between increased social anxiety and decreased self-disclosure, 
and resulting decreased feelings of emotional intimacy. 

 
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4.0 
Study Endpoints* 
4.1 N/A 
 
5.0 
Study Intervention/Investigational Agent 
5.1 Description: Social anxiety safety behavior fading intervention 
procedures will follow methodology previously used in the Cougle 
Lab. The safety behavior fading intervention is designed to target a 
decrease or elimination of five social anxiety safety behaviors that 
an individual has self-identified that they engage in most frequently 
and/or to the greatest extent.  
Individuals randomly assigned to the safety behavior fading 
condition will receive instructions to decrease or eliminate their five 
social anxiety safety behaviors. In addition, they will receive daily 
reminders via text message to decrease these behaviors, along with a 
safety behavior monitoring checklist in which the participant 
indicates the extent to which they decreased and/or eliminated each 
safety behavior over the previous day. The daily reminder will 
include the following language: “Hi! This is a friendly reminder to 
avoid using your checklist behaviors. Please tap the link below to 
access today’s checklist: [link to checklist].” 
Individuals randomly assigned to the control condition will receive 
text messages to encourage fading of “unhealthy behaviors”. They 
will follow the same procedure as the safety behavior fading group. 
  
6.0 
Procedures Involved* 
6.1 Participants will be recruited through online postings. 
Once they sign up, all participants will be asked to provide informed 
consent before participating in the current study. After consenting, 
the participant will complete the first battery of self-report measures. 
If the participant scores a 30 or lower on the SPIN, they will not be 
eligible to participate 
If they score a 30 or above on the SPIN and meet all eligibility 
criteria, participants will be randomly assigned to one of two 
experimental conditions: Safety Behavior (SB) Fading Condition or 
control condition. During this pre-assessment virtual appointment, 
participants will complete a questionnaire battery assessing related 
symptoms and concerns, as well as safety behaviors. Participants in 
the SB fade condition will select five behaviors from their completed 
Safety Avoidance Frequency Examination (SAFE) that they engage 
in the most. They will be informed that the researchers are interested 

 
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in the extent to which people can engage in these behaviors less than 
they normally do on a daily basis, for twoweeks. Participants in the 
“healthy behaviors” group will be told they will be sent a checklist 
of healthy behaviors. 
Participants will also receive instructions regarding how to 
complete their daily safety behavior monitoring checklist. They will 
receive 14 checklists via text over the course of the nexttwo  weeks 
(assessment period).  Daily checklists will take roughly 5-minutes 
each.   
At the end of four weeks all participants will be sent a second set of 
questionnaires via email to complete. 
6.2 Screening: Social Phobia Inventory (SPIN; Connor et al., 2000) 
Pre-assessment virtual appointment components: 
Component 1: Self-Report Assessments – Participants will complete 
a battery of self-report measures that assess relevant constructs.  
The questionnaires included are: 
1. Basic demographic information 
2. SCID-II Personality Questionnaire: Avoidant Personality 
Disorder (AVPD) Items (American Psychiatric Association, 1986) 
3. Center for Epidemiologic Studies Depression Scale (CESD; 
Radloff, 1977) 
4. Self-Disclosure Index (SDI; Miller et al., 1983) 
5. Emotional Self-Disclosure Scale (ESDS; Snell et al., 1988) 
6. UCLA Loneliness Scale (ULS; Hays & Dimatteo, 1987) 
7. Subtle Avoidance Frequency Examination (SAFE; Cuming et al., 
2009) 
8.Social Phobia Inventory (SPIN; Connor et al., 2000) 
Component 2: Treatment rationale. Participants wil receive the 
following treatment rationale:  
Safety Behavior: Safety behaviors are behaviors we use to make us feel less 
anxious and prevent bad things from happening. For example, when in a social 
situation, some people might hide their faces so others won’t see them blush, or 
they may seek reassurance from others about things they said or how they look. 
Safety behaviors can be problematic because when we use them, we are never 
able to see that the outcome we fear doesn’t come true. We say to ourselves, “the 
reason nothing bad happened is because I got reassurance from others, I spoke 
softly, I didn’t draw attention to myself…” or used other safety behaviors. Safety 
behaviors can become a crutch and make you feel less confident in social 
situations. Research has found that dropping safety behaviors can help reduce 
anxiety. 

 
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Unhealthy Behaviors: Social anxiety like many other problems can keep us from 
taking care of ourselves. Engaging in unhealthy behaviors can make us feel even 
worse, and more anxious. For example, if people don’t sleep or eat enough, they 
might tend to be tired and feel like they are less able to handle their anxiety. This 
can create a cycle where we engage in unhealthy behaviors because of our 
anxiety and then that can make our anxiety worse and then engage in more 
unhealthy behaviors as a result. Also, spending too much time on social media or 
not moving around enough might lower your confidence and make it harder for 
you in social situations. Research has found that decreasing certain unhealthy 
behaviors can make you more confident and help improve mood and anxiety. 
They will then complete the Credibility/Expectancy Questionnaire 
(CEQ; Devilly & Borkovec, 2000). 
twp-week assessment period:  
Component 3: Safety Behavior Checklist (completed daily) 
Post-treatment: 
Component 4: Self-Report Assessments – Participants will complete 
a battery of self-report measures that assess relevant constructs.  
This battery will include all items from Component 1. 
Component 7: Debriefing – All participants will be informed of the 
actual, full study purpose. 
One month follow-up: 
Component 8: Self-Report Assessments – Participants will complete 
a battery of self-report measures that assess relevant constructs.  
This battery will include all items from Component 1 
6.3 The potential risks associated with participation in this study appear 
to be minimal (see below). 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 asked to sign an 
informed consent statement prior to participating in the project. 
Several safeguards for maintaining participant confidentiality will 
also be in place (see below). In addition, referrals to appropriate 
clinical services (e.g. FSU Psychology Clinic) will be provided for 
any participants seeking treatment. 
7.0 
Data and Specimen Banking* 
7.1 Data will be stored in de-identified databases in password protected 
files on encrypted computers. 
7.2 Results from questionnaires and surveys will be stored. 
7.3 Data will not be released. 

 
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8.0 
Sharing of Results with Subjects* 
8.1 Individual results will not be shared with participants. Participants 
will be able to read resulting journal articles as they are published. 
9.0 
Study Timelines* 
9.1 The total duration of an individual subject’s participation in the 
study is 6 weeks. This will include an initial questionnaire battery , 
four week manipulation assessment period, and the post-treatment 
questionnaire’s and one month follow up. We predict that it will take 
roughly 12-18 months to enroll all study subjects. 
 
10.0 Subject Population* 
10.1 Adults aged 18-65 recruited from across the United States  
10.2 Inclusion Criteria: The primary inclusion criteria for this study will 
be elevated social anxiety symptoms as defined by a score of 30 or 
higher on the SPIN. The only software/hardware requirements are 
that participants have access to a smartphone or computer that is 
connected to the internet.  
Exclusion Criteria: 1) Score of 29 or lower on the SPIN, 2) 
Currently receiving treatment (therapy, counseling, etc.) for anxiety 
or depression, 3) If applicable, unstable psychiatric medication 
usage any time over the past 4 weeks.  
10.3 We will not include: Adults unable to consent, Individuals who are 
not yet adults (infants, children, teenagers), Pregnant women, or 
Prisoners. 
11.0 Vulnerable Populations* 
11.1 N/A 
 
12.0 Local Number of Subjects 
12.1 500 
13.0 Recruitment Methods 
13.1 Participants will be recruited from across the United States through 
posting on internet websites such as Craigslist, Facebook, Reddit 
etc. Participants will be asked to sign consent before completing the 
SPIN and other screening questions. 
13.2 Participants will be recruited from across the United States. 
13.3 Participants who score at or above a 30 on the SPIN be invited to 
participate in the current study and provided with their 
questionnaire battery. 

 
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13.4 Potentially eligible participants will be contacted via email, with the 
initial questionnaire battery. 
13.5 Participants will be entered into a raffle for 10 $20 Amazon gift 
cards when they complete the post treatment assessment and will 
receive an additional entry into the raffle if they complete the one 
month follow up assessments. Raffles will occur at the end of 12 
months of study enrollment. We anticipate participants will have 1 in 
10 chance or greater of receiving a gift card. Participants email 
addresses will be retained until that time to deliver the gift cards. No 
other identifying information will be retained for this purpose. 
 
14.0 Withdrawal of Subjects* 
14.1 Participants will be withdrawn if there are circumstances that 
severely compromise the integrity of their data such as experimenter 
error, or if they do not meet eligibility criteria. 
14.2 Participants are allowed to withdraw from participation in the study 
at any point, and data collection will stop at that point. Participants 
will be consults as to whether or not they want their data removed 
from the final dataset. 
 
15.0 Risks to Subjects* 
15.1 Risks to human subjects in the present study are believed to be 
minimal. Nevertheless, precautions will be taken to minimize 
participants’ risk in the proposed study. All individuals will be 
informed of the general nature of the investigation and the types of 
assessments and procedures. Participants will be given an 
opportunity to have any questions answered to their satisfaction and 
then 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. 
There are two main areas of risk: 
1) Self-report Measures: Some participants may be hesitant to 
record their social anxiety and/or depressive symptoms on 
assessment forms. It is possible that questionnaires relating to social 
anxiety, depression, and perceived loneliness could lead to 
emotional discomfort for some participants. 
2) Confidentality: We will be collecting information about the 
participant that could cause social and psychological risk if released 
inappropriately. 
The above areas of risk will be minimized by the following 
procedures: 

 
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1) Participants will be made aware that they are free to omit 
questions they feel uncomfortable answering and are free to 
terminate their participation at any time during the study without 
penalty. While some participants may be hesitant to answer the 
assessment forms, others may derive benefit from the self-assessment 
as it could increase their awareness of the relationship between their 
symptoms and environmental, cognitive, and interpersonal factors. 
Participants will be encouraged to contact study staff at any point 
during the study if they have questions or concerns. Referrals to 
appropriate clinical services (e.g., FSU Psychology Clinic, the 
Anxiety and Behavioral Health Clinic) will be provided for any 
participants seeking treatment. All research staff will be trained to 
deal with sensitive clinical issues and will be available during the 
assessment process should participants need assistance. 
2) Breach of confidentiality is highly unlikely. Researchers will 
emphasize that information obtained during the study is confidential 
and will be used solely by research staff for research purposes. No 
data form will ever have a participant’s name on it. All records will 
be kept in locked files and secure servers and it will only be 
available to the necessary research personnel who know about 
human participant protection guidelines. A cross index of identity 
information will be kept in a separate location. In addition, all data 
will contain only a codified Identification Code, all assessment 
procedures will be closely supervised, and staff will be trained and 
reminded of the need to keep all information confidential. No names 
will be used in presenting the data in lectures, seminars, and papers. 
No individual responses will be reported in any publications.  
Information will be released only with the written consent of the 
participant. Having all information collected and handled by 
research staff trained to deal appropriately with sensitive clinical 
issues will minimize potential risk of loss of confidentiality. All 
information will be treated as confidential material and will be 
available only to research and clinical staff. The Key-file associating 
Identification Codes with identifying information will be destroyed 
once data collection is complete. We have used this approach with 
hundreds of participants in the past and have never had any 
problems with a breach of confidentiality. 
16.0 Potential Benefits to Subjects* 
16.1 A direct benefit to participants is that they will be entered in a raffle 
for 10 $20 gift cards. We anticipate participants will have 1 in 10 
chance or greater of receiving a gift card. 
Based on previous research, we anticipate, the safety behavior 
fading group may benefit from the study, as it is possible that 
reducing safety behaviors may result in reductions in symptoms and 
an increase in emotional disclosure.  

 
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17.0 Data Management* and Confidentiality 
17.1 2 X 2 mixed model ANOVAs will be conducted to evaluate the effect 
of the manipulation on study variables of interest.  
17.2 Subjects’ names and email addresses will be recorded upon their 
consenting to participate and used to send participants reminders 
about appointments. Further, participants in the SB Fade group will 
receive daily emails/texts during the two assessment weeks to remind 
them to complete their Behavior Checklist each day. However, no 
names or direct identifiers will be linked with the data collected over 
the course of the study. Each participant will be assigned a unique, 
codified Identification Code that is unrelated to the participants’ 
identifying information. All questionnaires will be labeled using their 
codified Identification Code. The Key-file associating Identification 
Codes with participant names, email addresses, and phone numbers 
will be kept by the principal investigator separate from all other 
study data and consent forms in a secured file. Email addresses are 
needed in order to send links to and reminders for the online 
appointments. Phone numbers are needed in order to send daily text 
message reminders to participants in the SB Fade condition. If an 
individual is unable or unwilling to supply their phone number, daily 
reminders will be sent to their email address. All study data will be 
stored in de-identified databases in password protected files on 
encrypted computers.  
No individual will ever be publicly identified. We will only report 
results that have been averaged over participants. No records or 
assessment information will be released to any other person. All 
identifying information will be deleted after data collection is 
complete.  
Participants will be informed that there are certain situations in 
which we may break confidentiality. If during the study we learn 
about child neglect, child or elder abuse, or that someone is a clear, 
serious, and direct harm to self or others, we may report the 
information to appropriate authorities, including the police or an 
emergency medical facility. Such a possibility is therefore explicitly 
stated in the consent document. All data and paperwork will be 
protected to the extent provided by law. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects*  
 
NA 
 

 
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19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 To facilitate privacy, participants will be informed that they can 
decline to answer any questions they do not wish to. 
Participants will not have access to responses to any questionnaire 
from any other participants, nor will future participants have access 
to the current participant’s responses.   
19.2 Participants are explained the limits of confidentiality and are told 
they do not have to answer any questions they do not want to. 
19.3 The aforementioned Key-file will contain identifying information 
(e.g., subject name, contact information) and study Identification 
Code numbers. This list will be kept separate from all other study 
data and will be password protected. Only study personnel will be 
given the password to this Key-file by the PI. All other data will 
contain Identification Code numbers only—no identifying 
information will be listed on any other data. 
20.0 Compensation for Research-Related Injury 
20.1 We do not anticipate any risk of research related injury to our 
participants. 
20.2 NA 
21.0 Economic Burden to Subjects 
21.1 We do not anticipate that participation in our study will cause any 
economic burden to our participants. 
22.0 Consent Process 
22.1 The participant will be given the opportunity to read through the 
consent form and give signed informed consent if they agree to 
participate. No data will be collected before consent is obtained. 
23.0 Process to Document Consent in Writing 
23.1 We will follow “SOP: Written Documentation of Consent (HRP-
091).”  
24.0 Setting 
24.1 Participation will involve completion of questionnaires and computer 
tasks on their personal computer. 
25.0 Resources Available 
25.1 Costs of research are estimated to be minimal and will be covered by 
funds from the Cougle Lab. 

 
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 
The research group has had success in the past recruiting 
student populations for online and in person studies including 
intervention studies.  
 
The researchers will have access to the research group lab 
space located on the Florida State University Campus, which 
will provide the necessary staff, equipment, and materials.  
 
All research personnel will complete the required Human 
Subjects Training and will be asked to demonstrate competence 
with the procedures per the standards of the study prior to 
their involvement. They will receive supervision and training 
from the graduate student overseeing the project regarding the 
study protocol, procedures, and their duties. All study 
personnel will also be trained to deal with sensitive clinical 
issues and will be available during the assessment process 
should participants need assistance.