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Behavioral Intervention

SilverCloud for Anxiety

N/A
Recruiting
Led By Erum Nadeem, 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

Study Summary

This trial aims to test the effectiveness of an app-based therapy program called SilverCloud for young people dealing with mental health issues. The study will first involve an open trial to see how well SilverCloud works

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in General Anxiety Disorder-7 (GAD-7) Score
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,478 Total Patients Enrolled
7 Trials studying Anxiety
632 Patients Enrolled for Anxiety
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,579 Total Patients Enrolled
82 Trials studying Anxiety
38,980 Patients Enrolled for Anxiety
Erum Nadeem, PhDPrincipal InvestigatorRutgers University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study open to individuals who are above 50 years of age?

"Participants aged between 13 and 22 years old are eligible for enrolment as per the study's eligibility criteria."

Answered by AI

What is the overall patient enrollment count for this clinical trial?

"Indeed, as per details on clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially listed on February 8th, 2024 and the latest update occurred on February 22nd of the same year. A total of 120 patients are sought from a single site."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for this research study?

"The research study is accepting 120 adolescents and young adults aged between 13 to 22 years with depression. Essential criteria for participation include enrollment in the School-Based Health Center at their high school, scoring above 10 on either the GAD-7 or PHQ-9 assessment tools, proficiency in English language (both spoken and written), being enrolled in grades nine through eleven, as well as exclusive access to the investigational variant of SilverCloud available solely in English."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, the data on clinicaltrials.gov confirms that this current study is actively seeking volunteers. The trial was initially posted on February 8th, 2024 and last updated on February 22nd, 2024. There is a need to recruit around 120 participants from one designated site."

Answered by AI

Who else is applying?

What site did they apply to?
Rutgers University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
SilverCloud as a School-Based Intervention for Vulnerable Youth
2024. "SilverCloud as a School-Based Intervention for Vulnerable Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004414.
All > Depression Philadelphia > Anxiety
~80 spots leftby Jan 2026
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