Social AnxietyNCT05168020
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety
A study testing Safety Behavior Fading for Social Anxiety and Unhealthy Behavior Fading in people with Social Anxiety, run by Florida State University at 1 site in United States.
Trial summary
The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Safety Behavior Fading for Social Anxiety and Unhealthy Behavior Fading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 24 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social Phobia Inventory Score >29
- Stable Psychotropic Medications for 4 weeks prior to participation
Who cannot join
- Currently participating in psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Evaluation of a Self-Monitoring Intervention to Reduce Safety Behaviors in Social Anxiety: A Randomized Controlled Trial
The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.
Read the detailed description
Safety behavior fading may be a viable standalone intervention for social anxiety. In the present trial, participants high in social anxiety will be randomized to either receive a daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their four most habitual 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. Individuals randomly assigned to the control condition will receive similar text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants in both conditions will complete checklists for 28 days. After day 14 of treatment, participants will re-select their target safety behaviors or unhealthy behaviors, and will then be prompted to reduce these new behaviors for another 14 days.
- Conditions
- Social Anxiety
- Being tested
- Safety Behavior Fading for Social Anxiety, Unhealthy Behavior Fading
- Keywords
- Social Anxiety, Safety Behaviors, Intervention, Text-message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Behavior Fading for Social AnxietyBehavioural
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress
Unhealthy Behavior FadingBehavioural
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress
| Study group | Role | What they receive |
|---|---|---|
| Safety Behavior Fading | Experimental | Participants will be asked to identify their five most common SBs from the SAFE. Participants will then be shown a sample checklist with instructions to fill it out. For the next 14 days, participants will receive the following text message "Please remember to avoid using SBs you selected. As you drop them, you'll be able to go into social situations with greater confidence!" with a link for their daily checklist to complete. Participants will be asked to rate how often they engaged in each SB over the past 24 hours Receives: Behavioral: Safety Behavior Fading for Social Anxiety |
| Unhealthy Behavior Fading | Active comparator | Participants will be asked to pick five unhealthy behaviors they engage in most often to decrease. Participants will then be shown the same sample checklist as the Safety Behavior Fading Group. For the next 14 days participants will receive the following text message "Please try to remember to decrease your unhealthy behaviors. As you decrease them you will feel better, and you'll be able to go into social situations with greater confidence!" with a link for their daily checklist to complete. Participants will be asked to rate how often they engaged in each Unhealthy Behavior over the past 24 hours. Receives: Behavioral: Unhealthy Behavior Fading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Phobia Inventory Score
Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Measured: Day 0, Day 14, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start28 Sep 2021
- Primary completion24 Oct 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in to one of two conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168020
- Sponsor's protocol ID
- STUDY00002247
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Self-Monitoring Intervention to Reduce Safety Behaviors in Social Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05168020
- Acronym / sponsor ID
- STUDY00002247
- Conditions
- Social Anxiety
- Keywords
- Social Anxiety, Safety Behaviors, Intervention, Text-message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.
Detailed description
Safety behavior fading may be a viable standalone intervention for social anxiety. In the present trial, participants high in social anxiety will be randomized to either receive a daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their four most habitual 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. Individuals randomly assigned to the control condition will receive similar text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants in both conditions will complete checklists for 28 days. After day 14 of treatment, participants will re-select their target safety behaviors or unhealthy behaviors, and will then be prompted to reduce these new behaviors for another 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized in to one of two conditions
| Arm | Type | Receives |
|---|---|---|
| Safety Behavior Fading | Experimental | Behavioral: Safety Behavior Fading for Social AnxietyParticipants will be asked to identify their five most common SBs from the SAFE. Participants will then be shown a sample checklist with instructions to fill it out. For the next 14 days, participants will receive the following text message "Please remember to avoid using SBs you selected. As you drop them, you'll be able to go into social situations with greater confidence!" with a link for their daily checklist to complete. Participants will be asked to rate how often they engaged in each SB over the past 24 hours |
| Unhealthy Behavior Fading | Active comparator | Behavioral: Unhealthy Behavior FadingParticipants will be asked to pick five unhealthy behaviors they engage in most often to decrease. Participants will then be shown the same sample checklist as the Safety Behavior Fading Group. For the next 14 days participants will receive the following text message "Please try to remember to decrease your unhealthy behaviors. As you decrease them you will feel better, and you'll be able to go into social situations with greater confidence!" with a link for their daily checklist to complete. Participants will be asked to rate how often they engaged in each Unhealthy Behavior over the past 24 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Social Phobia Inventory Score >29
- Stable Psychotropic Medications for 4 weeks prior to participation
Key exclusion criteria (1 listed)
- Currently participating in psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Behavior Fading for Social AnxietyParticipants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress | Behavioural | Safety Behavior Fading |
| Unhealthy Behavior FadingParticipants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress | Behavioural | Unhealthy Behavior Fading |
Primary outcome
Change in Social Phobia Inventory Score
Time frame: Day 0, Day 14, Day 42
Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Behavior Fading for Social Anxiety and Unhealthy Behavior Fading in people with Social Anxiety, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Phobia Inventory Score (time frame: Day 0, Day 14, Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.