- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408102
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jamie C Chiu, PsyD
- Phone Number: (609) 258-4442
- Email: jamiechiu@princeton.edu
Study Locations
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New Jersey
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Princeton, New Jersey, United States, 08540
- Princeton University, but recruitment and study are conducted completely online and can occur anywhere in the US.
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Contact:
- Jamie C Chiu, PsyD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 65 years
- Live in the United States
- Comfortable reading and writing in English
- Have regular access to the internet and a desktop/laptop computer
- Report wanting to feel more comfortable in social situations, to improve social confidence, and/or to reduce symptoms of social anxiety as primary reason for joining the study
- Have a valid photo ID and be willing to complete a video-based identity verification call if requested
Exclusion Criteria:
- Lack of attention when completing parts of the study, and/or not completing the study tasks as instructed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
All participants are assigned to the e-couch social anxiety program.
Over a 5-week study period, participants are instructed to complete specific modules on a weekly schedule.
They are asked to engage with the program at least once per week for approximately 30 minutes.
Participants receive weekly reminders and guidance indicating which modules to complete each week.
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Participants will be offered the use of a self-help tool, e-couch (https://ecouch.com.au), for 5 weeks.
e-couch is an online, self-directed tool that provides interactive self-help and evidence-based information to help users understand and manage common mental health challenges including symptoms of depression and anxiety.
The e-couch social anxiety program will be used in this study.
It is structured like an interactive self-help book and participants can log back into at any time to learn and review skills.
The e-couch social anxiety program includes a comprehensive information module, as well as self-help modules with interactive exercises and workbooks that teach evidence-based strategies.
The content will cover topics such as cognitive restructuring and exposure, with an emphasis on learning strategies to reduce social anxiety.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Predictive accuracy of change in social anxiety symptom severity, as measured by Liebowitz Social Anxiety Scale (LSAS) total score, from baseline to end of intervention (5 weeks)
Time Frame: Baseline (pre-intervention) to end of intervention (5 weeks)
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Social anxiety symptom severity will be assessed using the Liebowitz Social Anxiety Scale (LSAS), a validated self-report questionnaire measuring fear and avoidance across social interaction and performance situations. The LSAS total score ranges from 0 to 144, with higher scores indicating greater social anxiety symptom severity. LSAS total scores will be collected at baseline (pre-intervention) and at the end of the 5-week e-couch intervention period. The outcome metric is the individual-level change in LSAS total score, calculated as the end-of-intervention score minus the baseline score. The primary outcome is the accuracy with which pre-intervention self-report measures and computerized behavioral task performance predict change in LSAS total score. Analyses will examine the extent to which individual differences in decision-making and cognitive task performance account for variability in symptom change across participants. |
Baseline (pre-intervention) to end of intervention (5 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yael Niv, PhD, Princeton University
- Principal Investigator: Jamie C Chiu, PsyD, Princeton University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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