DepressionNCT06004414
SilverCloud as a School-Based Intervention for Vulnerable Youth
A study testing App-based Cognitive Behavioral Therapy (CBT) and Psychotherapy in people with Depression and Anxiety, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 22 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- App-based Cognitive Behavioral Therapy (CBT) and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erum Nadeem, PhD contact
United States3 sites, 3 recruiting
- Recruiting
NYU Langone Health
Brooklyn, New York, 11220
- Not yet recruiting
Northwell Health School Mental Health Partnership sites
Glen Oaks, New York, 11004
Glen Oaks
Vera Feuer, MD
- Not yet recruiting
Rutgers University
New Brunswick, New Jersey, 08901
Erum Nadeem, Ph.D.
About this study
Official title: Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
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
- Being tested
- App-based Cognitive Behavioral Therapy (CBT), Psychotherapy
- Keywords
- depression, anxiety, behavioral therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Cognitive Behavioral Therapy (CBT)Behavioural
Also called SilverCloud
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.
PsychotherapyBehavioural
Psychotherapy with a licensed clinician at one of the study sites.
| Study group | Role | What they receive |
|---|---|---|
| SilverCloud | Experimental | Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud. Receives: Behavioral: App-based Cognitive Behavioral Therapy (CBT) |
| Treatment as Usual (TAU) | Active comparator | Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy. Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.
Measured: Baseline, Week 8
Change in General Anxiety Disorder-7 (GAD-7) Score
The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.
Measured: Baseline, Week 8
Secondary outcomes (5)
Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score
The RCADS-25 is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. Each item is rated as 0 (never), 1 (sometimes), 2 (often), or 3 (always). The raw score is the sum of responses and is converted to a T-score where: below 65 = normal range; between 65-69 = borderline clinical range; and 70 above = clinical range.
Measured: Baseline, Week 8
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score
This is an 8-item questionnaire assessing pediatric peer relationships. Each item is rated on a scale from 1 (never) to 5 (almost always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger peer relationships.
Measured: Baseline, Week 8
Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a
This is an 8-item questionnaire assessing pediatric family relationships. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate stronger family relationships.
Measured: Baseline, Week 8
Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a
This is an 8-item questionnaire assessing pediatric sleep disturbance. Each item is rated on a scale from 1 (never) to 5 (always). A raw score is calculated based on the sum of item responses. The raw score is converted to a T-score ranging from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more prevalent sleep disturbance.
Measured: Baseline, Week 8
Change in School Engagement Scale Score
23-item questionnaire assessing engagement in school. Each item is rated on a 6-point scale ranging from 1-5. The total score is the sum of responses and ranges from 23 to 115. Higher scores indicate greater school engagement.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start8 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Anna Van Meter, PhD, Principal investigator, NYU Langone HealthErum Nadeem, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004414
- Sponsor's protocol ID
- 23-00257
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the NIMH Data Archive. Data will be made available following article publication or as required by a condition of awards and agreements supporting the research. Data are available indefinitely through the NIMH Data Archive. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type I Effectiveness-implementation Trial of SilverCloud as a School-based Intervention for Vulnerable Youth
- ClinicalTrials.gov ID
- NCT06004414
- Acronym / sponsor ID
- 23-00257
- Conditions
- Depression, Anxiety
- Keywords
- depression, anxiety, behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SilverCloud | Experimental | Behavioral: App-based Cognitive Behavioral Therapy (CBT)Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: PsychotherapyAdolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Cognitive Behavioral Therapy (CBT)Also: SilverCloudSilverCloud 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. | Behavioural | SilverCloud |
| PsychotherapyPsychotherapy with a licensed clinician at one of the study sites. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Week 8
The PHQ-9 is a 9-item questionnaire assessing the degree of depression severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depression.
Change in General Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline, Week 8
The GAD-7 is a 7-item questionnaire assessing the degree of anxiety severity. Items are ranked on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; higher scores indicate greater severity of anxiety.
5 secondary outcomes
Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score
Time frame: Baseline, Week 8
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score
Time frame: Baseline, Week 8
Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a
Time frame: Baseline, Week 8
Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a
Time frame: Baseline, Week 8
Change in School Engagement Scale Score
Time frame: Baseline, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the NIMH Data Archive. Data will be made available following article publication or as required by a condition of awards and agreements supporting the research. Data are available indefinitely through the NIMH Data Archive. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erum Nadeem, PhD contact
Anna Van Meter, PhD principal investigator
NYU Langone Health
Erum Nadeem, PhD principal investigator
Rutgers University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based Cognitive Behavioral Therapy (CBT) and Psychotherapy in people with Depression and Anxiety, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Van Meter, PhD (646-754-5085, anna.vanmeter@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) Score (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.