WithdrawnNot Applicable

Waitlist-Control Trial of Smartphone (App-based) CBT for Social Anxiety Disorder (SAD), Withdrawn

Stopped: No longer proceeding with this study.

United States0Started 2023-09-01

Plain-language summary

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years of age * Current diagnosis of primary DSM-5 SAD, based on MINI * Currently living in the United States Exclusion Criteria: * Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period * Past participation in ≥ 4 sessions of CBT for SAD * Current severe substance use disorder * Lifetime bipolar disorder or psychosis * Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 \*\*\*EDIT\*\*\* * Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS * Concurrent psychological treatment * Does not own a supported mobile Smartphone with a data plan * Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in SAD severity (LSAS) at the end of treatment/waitlist period.

Timeframe: Endpoint (week 12)

Trial details

NCT IDNCT04622930

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Social Anxiety Disorder trials