Recruiting

SilverCloud

Sponsor:

NYU Langone Health

Code:

NCT06004414

Conditions

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 13 - 22

Healthy Volunteers: Not accepted

Interventions

App-based Cognitive Behavioral Therapy (CBT)

Psychotherapy

Study Details

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 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.

Conditions

Depression

Anxiety

Study ID

NCT06004414

Start date

Feb 8, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 22

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: SilverCloud

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud.

active comparator: Treatment as Usual (TAU)

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy.

Interventions

App-based Cognitive Behavioral Therapy (CBT)

SilverCloud is organized into eight core modules that follow evidence-based principles of CBT, along with six additional modules that can be prescribed by the clinician to address a participant's specific needs.

Psychotherapy

Psychotherapy with a licensed clinician at one of the study sites.

Primary outcome measure

  • Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Baseline, Week 8 ]
  • Change in General Anxiety Disorder-7 (GAD-7) Score [ Time Frame: Baseline, Week 8 ]

Central Contacts and Locations

Central contacts

Anna Van Meter, PhD

646-754-5085anna.vanmeter@nyulangone.org

Erum Nadeem, PhD

Erum.nadeem@rutgers.edu

Locations

NYU Langone Health

Recruiting

Brooklyn, New York, United States, 11220

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • depression
  • anxiety
  • behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-30.