Status:
RECRUITING
SilverCloud as a School-Based Intervention for Vulnerable Youth
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Anxiety
Eligibility:
All Genders
13-22 years
Phase:
NA
Brief Summary
The goal of this study is to test the efficacy and feasibility of a clinician-guided, app-based cognitive behavioral therapy (CBT) program, SilverCloud, as a school-based mental health intervention fo...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in the phase I open trial of this study, an individual must meet all of the following criteria:
- Enrolled in a high school
- Score of 10+ on GAD-7 or PHQ-9
- Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
- In order to be eligible to participate in the RCT of this study, an individual must meet all of the following criteria:
- Enrolled in 9th through 11th grades.
- Score of 10+ on GAD-7 or PHQ-9
- Enrolled in one of the study sites
- Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English.
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in the phase I open trial of this study:
- Does not use a smartphone
- Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
- Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated.
- An individual who meets any of the following criteria will be excluded from participation in the RCT of this study:
- Current (within 1 month of enrollment) mental health treatment at one of the study sites
- Does not use a smartphone
- Mental health concerns for which intensive treatment is indicated. Because SilverCloud has not been evaluated in people with serious mental illness, participants who exhibit symptoms of mania or psychosis will be referred to a higher level of care.
- Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred for crisis intervention through the site at which they were referred and will not be eligible until their suicidal thoughts have abated.
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06004414
Start Date
February 8 2024
End Date
December 31 2026
Last Update
May 18 2025
Active Locations (3)
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1
Rutgers University
New Brunswick, New Jersey, United States, 08901
2
NYU Langone Health
Brooklyn, New York, United States, 11220
3
Northwell Health School Mental Health Partnership sites
Glen Oaks, New York, United States, 11004