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Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Behavior Fading for Social Anxiety
Unhealthy Behavior Fading
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety focused on measuring Social Anxiety, Safety Behaviors, Intervention, Text-message

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Social Phobia Inventory Score >29
  • Stable Psychotropic Medications for 4 weeks prior to participation

Exclusion Criteria:

  • Currently participating in psychotherapy

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Safety Behavior Fading

Unhealthy Behavior Fading

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2021
Last Updated
April 28, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05168020
Brief Title
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety
Official Title
Text Message Safety Behavior Fading Intervention for Social AnxietyEvaluation of a Self-Monitoring Intervention to Reduce Safety Behaviors in Social Anxiety: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to a control intervention.
Detailed Description
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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
Social Anxiety, Safety Behaviors, Intervention, Text-message

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized in to one of two conditions
Masking
Participant
Masking Description
Participants will receive one of two matched interventions. They will not be told whether they are receiving the active or control intervention
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Behavior Fading
Arm Type
Experimental
Arm Description
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
Arm Title
Unhealthy Behavior Fading
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Safety Behavior Fading for Social Anxiety
Intervention Description
Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress
Intervention Type
Behavioral
Intervention Name(s)
Unhealthy Behavior Fading
Intervention Description
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress
Primary Outcome Measure Information:
Title
Change in Social Phobia Inventory Score
Description
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 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Social Phobia Inventory Score >29 Stable Psychotropic Medications for 4 weeks prior to participation Exclusion Criteria: Currently participating in psychotherapy
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety

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