What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT), including app-based versions like SilverCloud, is a common treatment for anxiety. Known side effects of CBT are generally minimal but can include temporary increases in anxiety or distress as patients confront their fears and work through challenging thoughts. Other potential side effects may include emotional discomfort during sessions and fatigue from the mental effort required. Overall, CBT is considered a safe and effective treatment for anxiety with few adverse effects.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for anxiety disorders, including Selective Serotonin Reuptake Inhibitors (SSRIs) like sertraline and fluoxetine, and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) such as venlafaxine. Benzodiazepines like alprazolam have also been approved for short-term relief of anxiety symptoms. In addition to these medications, Cognitive Behavioral Therapy (CBT) is a well-established, non-pharmacological treatment for anxiety. The SilverCloud trial is exploring an app-based version of CBT, which aims to provide accessible, effective mental health support for anxiety.

What other types of research exist?

Promising alternatives to SilverCloud for app-based CBT for anxiety patients include MindSpot Clinic, which has shown effectiveness in delivering online CBT for anxiety and depression, and various internet-delivered treatments for panic disorder that have demonstrated efficacy and acceptability. Additionally, smartphone-assisted guided self-help programs and transdiagnostic CBT interventions delivered through apps have shown positive outcomes in recent trials.

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Behavioral Intervention

App-Based CBT for Anxiety and Depression

N/A

Recruiting

Led By Anna Van Meter, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For phase I open trial: Score of 10+ on GAD-7 or PHQ-9

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 8

Awards & highlights

Summary

This trial tests SilverCloud, an app-based therapy program guided by a therapist, for adolescents with significant mental health symptoms in school-based health centers. The app helps users change negative thoughts and behaviors with therapist support.

Who is the study for?

This trial is for high school students in grades 9-11 who are experiencing symptoms of depression or anxiety, have a score of 10+ on GAD-7 or PHQ-9, and can speak/read English. They must be enrolled in their school's health center to participate.

What is being tested?

The study tests SilverCloud, an app-based CBT program guided by clinicians, against the usual treatment methods. It aims to see if it's effective and practical as a mental health intervention for vulnerable youth in schools.

What are the potential side effects?

Since this trial involves psychotherapy through an app-based platform rather than medication, side effects may include emotional discomfort due to confronting personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I scored 10 or higher on a depression or anxiety scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in General Anxiety Disorder-7 (GAD-7) Score

Change in Patient Health Questionnaire-9 (PHQ-9) Score

Secondary study objectives

Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a

Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SilverCloudExperimental Treatment1 Intervention

Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive SilverCloud.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

Adolescents who screen positive for significant mental health symptoms and who are enrolled in their school-based health center (SBHC) randomized to receive psychotherapy.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for anxiety include Cognitive Behavioral Therapy (CBT) and pharmacotherapy with Selective Serotonin Reuptake Inhibitors (SSRIs). CBT works by helping patients identify and challenge negative thought patterns and behaviors, replacing them with more positive and adaptive ones. This is achieved through techniques such as cognitive restructuring and exposure therapy. SSRIs, on the other hand, increase the levels of serotonin in the brain, which can help improve mood and reduce anxiety. Understanding these mechanisms is crucial for anxiety patients as it helps them comprehend how these treatments can alleviate their symptoms. App-based CBT, like SilverCloud, leverages these principles by providing structured, accessible therapy that can be used in real-time, making it a practical and effective option for managing anxiety.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,397 Previous Clinical Trials

861,722 Total Patients Enrolled

7 Trials studying Anxiety

632 Patients Enrolled for Anxiety

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,416 Total Patients Enrolled

86 Trials studying Anxiety

40,203 Patients Enrolled for Anxiety

Anna Van Meter, PhDPrincipal InvestigatorNYU Langone Health

~80 spots leftby Jan 2026

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