NCT05168020

Brief Summary

The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2022

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

November 24, 2021

Last Update Submit

December 5, 2023

Conditions

Keywords

Social AnxietySafety BehaviorsInterventionText-message

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Safety Behavior Fading

EXPERIMENTAL

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

Unhealthy Behavior Fading

ACTIVE COMPARATOR

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

Interventions

Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress

Safety Behavior Fading

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

Unhealthy Behavior Fading

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Currently participating in psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will receive one of two matched interventions. They will not be told whether they are receiving the active or control intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized in to one of two conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 22, 2021

Study Start

September 28, 2021

Primary Completion

October 24, 2022

Study Completion

November 24, 2022

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations