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NCT06168253 Clinical Trial

Text Message Safety Behavior Fading for Social Anxiety

Social Anxiety Clinical Trial

Official title:
Text Message Safety Behavior Fading Intervention for Social Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06168253
Other study ID # STUDY2247MOD4140
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date June 1, 2024

Study information
Verified date January 2024
Source Florida State University
Contact James M Zech, MA
Phone 203 517 7111
Email zech@psy.fsu.edu
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 Recruiting
Enrollment 124
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
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 for social anxiety

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 (SPIN) 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 Change in Center For Epidemiological Studies Depression Scale, Ten Item Version (CESD-10) A 10-item self-report scale measuring depression symptoms; higher scores indicate greater depressive symptoms. Time Frame: Day 0, Day 28, Day 56
Secondary Change in UCLA Loneliness Scale, Short Form (ULS-8) An 8-item self-report measure of subjective loneliness, with higher scores indicating greater loneliness. Time Frame: Day 0, Day 28, Day 56
Secondary Change in Self-Beliefs Related to Social Anxiety Scale (SBSA) A 15-item scale measuring common and generally maladaptive beliefs related to social anxiety. Time Frame: Day 0, Day 28, Day 56
Secondary Change in Subtle Avoidance Frequency Examination (SAFE) scale A 32-item self-report measure of safety behavior usage frequency Time Frame: Day 0, Day 28, Day 56
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