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

NCT ID: NCT05168020

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2022-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Social Anxiety Safety Behaviors Intervention Text-message

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized in to one of two conditions
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will receive one of two matched interventions. They will not be told whether they are receiving the active or control intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Safety Behavior Fading for Social Anxiety

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Unhealthy Behavior Fading

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safety Behavior Fading for Social Anxiety

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

Intervention Type BEHAVIORAL

Unhealthy Behavior Fading

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Currently participating in psychotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jesse Cougle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida State University

Tallahassee, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00002247

Identifier Type: -

Identifier Source: org_study_id