- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168253
Text Message Safety Behavior Fading for Social Anxiety
February 20, 2025 updated by: Jesse Cougle, Florida State University
Text Message Safety Behavior Fading Intervention for Social Anxiety
The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
201
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32312
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Social Phobia Inventory Score >29
- Stable Psychotropic Medications for 4 weeks prior to participation
Exclusion Criteria:
- Currently participating in psychotherapy for social anxiety
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Safety Behavior Fading
This treatment lasts a total of 28 days.
Participants will be asked to identify common safety behaviors related to social anxiety.
For the next 14 days, participants will receive instructions to fade out these behaviors.
After 14 days, participants will be asked to re-select their target safety behaviors and continue to reduce them over the next two weeks.
|
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress.
|
|
Active Comparator: Unhealthy Behavior Fading
This treatment lasts a total of 28 days.
Participants will be asked to identify common unhealthy behaviors related to social anxiety.
For the next 14 days, participants will receive instructions to fade out these behaviors.
After 14 days, participants will be asked to re-select their target unhealthy behaviors and continue to reduce them over the next two weeks.
|
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Phobia Inventory (SPIN)
Time Frame: Time Frame: Day 0, Day 14, Day 28, Day 56
|
Self-report scale that measures Social anxiety symptoms.
Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
|
Time Frame: Day 0, Day 14, Day 28, Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Center For Epidemiological Studies Depression Scale, Ten Item Version (CESD-10)
Time Frame: Time Frame: Day 0, Day 28, Day 56
|
A 10-item self-report scale measuring depression symptoms; higher scores indicate greater depressive symptoms.
|
Time Frame: Day 0, Day 28, Day 56
|
|
Change in UCLA Loneliness Scale, Short Form (ULS-8)
Time Frame: Time Frame: Day 0, Day 28, Day 56
|
An 8-item self-report measure of subjective loneliness, with higher scores indicating greater loneliness.
|
Time Frame: Day 0, Day 28, Day 56
|
|
Change in Self-Beliefs Related to Social Anxiety Scale (SBSA)
Time Frame: Time Frame: Day 0, Day 28, Day 56
|
A 15-item scale measuring common and generally maladaptive beliefs related to social anxiety.
|
Time Frame: Day 0, Day 28, Day 56
|
|
Change in Subtle Avoidance Frequency Examination (SAFE) scale
Time Frame: Time Frame: Day 0, Day 28, Day 56
|
A 32-item self-report measure of safety behavior usage frequency
|
Time Frame: Day 0, Day 28, Day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
December 5, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Actual)
December 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 20, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2247MOD4140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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