Anxiety, Depression
Conditions
Keywords
depression, anxiety, behavioral therapy
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.
Interventions
BEHAVIORALApp-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.
BEHAVIORALPsychotherapy
Psychotherapy with a licensed clinician at one of the study sites.
Sponsors
NYU Langone Health
National Institute of Mental Health (NIMH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 22 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Revised Children's Anxiety and Depression Scale (RCADS-25) Youth Self-Report Score | Baseline, Week 8 | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Peer Relationships - Short Form 8a Score | Baseline, Week 8 | 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. |
| Change in PROMIS Pediatric Item Bank v1.0 - Family Relationships - Short Form 8a | Baseline, Week 8 | 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. |
| Change in PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a | Baseline, Week 8 | 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. |
| Change in School Engagement Scale Score | Baseline, Week 8 | 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. |
Countries
United States
Contacts
CONTACTAnna Van Meter, PhD
CONTACTErum Nadeem, PhD
PRINCIPAL_INVESTIGATORAnna Van Meter, PhD
NYU Langone Health
PRINCIPAL_INVESTIGATORErum Nadeem, PhD
Rutgers University
Outcome results
None listed