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NCT05168020 Clinical Trial

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

Social Anxiety Clinical Trial

Official title:
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behaviors in Social Anxiety: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05168020
Other study ID # STUDY00002247
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date November 24, 2022

Study information
Verified date December 2023
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date November 24, 2022
Est. primary completion date October 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Social Phobia Inventory Score >29 - Stable Psychotropic Medications for 4 weeks prior to participation Exclusion Criteria: - Currently participating in psychotherapy

Study Design

Related Conditions & MeSH terms

Intervention

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
• Unhealthy Behavior Fading
Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress

Locations
Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (1)
Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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