NCT06168253

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
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

December 5, 2023

Last Update Submit

February 20, 2025

Conditions

Keywords

Social AnxietySafety BehaviorsInterventionText-message

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Center For Epidemiological Studies Depression Scale, Ten Item Version (CESD-10)

    Time Frame: Day 0, Day 28, Day 56

  • Change in UCLA Loneliness Scale, Short Form (ULS-8)

    Time Frame: Day 0, Day 28, Day 56

  • Change in Self-Beliefs Related to Social Anxiety Scale (SBSA)

    Time Frame: Day 0, Day 28, Day 56

  • Change in Subtle Avoidance Frequency Examination (SAFE) scale

    Time Frame: Day 0, Day 28, Day 56

Study Arms (2)

Experimental: Safety Behavior Fading

EXPERIMENTAL

This treatment lasts a total of 28 days. Participants will be asked to identify common safety behaviors related to social anxiety. For the next 14 days, participants will receive instructions to fade out these behaviors. After 14 days, participants will be asked to re-select their target safety behaviors and continue to reduce them over the next two weeks.

Behavioral: Safety Behavior Fading for Social Anxiety

Unhealthy Behavior Fading

ACTIVE COMPARATOR

This treatment lasts a total of 28 days. Participants will be asked to identify common unhealthy behaviors related to social anxiety. For the next 14 days, participants will receive instructions to fade out these behaviors. After 14 days, participants will be asked to re-select their target unhealthy behaviors and continue to reduce them over the next two weeks.

Behavioral: Unhealthy Behavior Fading

Interventions

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

Experimental: 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 for social anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32312, 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 will be randomized in to one of two conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations