No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
13 – 22
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
120 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for high school students experiencing depression or anxiety. Participants will use the SilverCloud app for mental health support and share their experiences to improve the program.
Are You a Good Fit for This Trial?
You may be able to join if
I am enrolled in high school.
I have scored 10 or higher on anxiety or depression screening.
I can read and understand English.
You may not be able to join if
I do not use a smartphone.
I need intensive treatment for my mental health concerns.
I currently have thoughts of suicide and a plan for it.
I am receiving mental health treatment at a study site in the last month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and con…
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 for vulnerable youth. An open trial of SilverCloud will be conducted to determine preliminary efficacy in this sample and inform program refinements by collecting outcome self-report assessments and conducting interviews on feasibility and acceptability. After the program and its implementation strategy are refined, we will conduct an randomized controlled trial. Adolescents who seek or are referred for mental health services through one of the study sites and screen positive for significant mental health symptoms will be randomized to receive SilverCloud or treatment as usual (TAU). Efficacy will be assessed through outcome self-reports. Feasibility and acceptability feedback will again be collected from participants, SBHC staff, and community members.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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…
Inclusion Criteria:
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 Criteria:
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.
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