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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Behavioral: Safety Behavior Fading for Social Anxiety; Behavioral: Unhealthy Behavior Fading

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): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32304
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Behavior Fading; 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	Behavioral: Safety Behavior Fading for Social Anxiety; Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress
Active Comparator: Unhealthy Behavior Fading; 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.	Behavioral: Unhealthy Behavior Fading; 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 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.	Day 0, Day 14, Day 42

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Social Anxiety; Intervention; Safety Behaviors; Text-message
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STUDY00002247

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