Project YES for Depression and Anxiety

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Imminent suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program aimed at reducing symptoms of depression, anxiety, and eating disorders in young people. Participants will engage with one of three online interventions that teach skills such as positive thinking, self-talk, and taking action. The researchers aim to determine if these tools improve mental health over time. It suits young people aged 13 to 25 who have noticed signs of depression or anxiety and are comfortable with English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that these digital SSIs are safe for adolescents and young adults?

Research has shown that Project YES, a digital platform for mental health, is generally well-received. Studies have found that the activities are short, easy to do independently, and designed for teens and young adults. These activities teach skills such as growth mindset (believing improvement comes with practice), neutral self-talk (maintaining balanced self-dialogue), and behavioral activation (engaging in activities to boost mood).

Previous trials found these activities acceptable and effective for various groups of young people. No serious side effects were reported, indicating that the activities are safe. Overall, Project YES offers a promising and safe method to help manage depression and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Project YES is unique because it offers a digital, self-guided approach to treating depression and anxiety in adolescents. Unlike traditional therapies that often require in-person sessions with a therapist, Project YES allows teens to learn cognitive-behavioral therapy (CBT) skills at their own pace through interactive exercises and fictional peer stories. This program focuses on teaching a growth mindset, neutral self-talk, and behavioral activation, making mental health support more accessible and less intimidating. Researchers are excited about Project YES because it could empower young people to manage their mental health independently and might reach those who lack access to traditional therapy.

What evidence suggests that Project YES might be an effective treatment for depression and anxiety?

Research has shown that Project YES, a digital one-time session, may help young people with depression and anxiety. This trial will evaluate different components of Project YES, including Project Personality, Project CARE, and the ABC project. Previous studies on Project Personality found that teens felt less hopeless, experienced less self-hatred, and showed improvements in depression and anxiety symptoms. These programs use skills from cognitive-behavioral therapy (CBT), teaching ways to think and act more healthily. By focusing on concepts like growth mindset and positive self-talk, Project YES aims to help young people manage their emotions better and feel less distress. Overall, this approach has demonstrated positive effects on teenagers' mental health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young people aged 13-25 who show signs of depression or anxiety during regular check-ups. It's designed to help those at risk for eating disorders and depression.

Inclusion Criteria

Patient at Lurie Division of Adolescent and Young Adult Medicine

I am between 13 and 25 years old.

Provider agreement that this would be an appropriate intervention

Exclusion Criteria

Imminent risk for suicide as indicated by a 'Yes' response to questions #5 on the Ask Suicide Questions (ASQ) Screener

I cannot speak or understand English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive one of three digital single-session interventions targeting risk factors for depression and eating disorders

1 session

1 visit (virtual)

Follow-up

Participants are monitored for changes in depression, anxiety, and eating disorder symptoms

12 weeks

Questionnaires at baseline, immediately after intervention, and 12-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Project YES

Trial Overview Project YES involves digital single-session interventions (SSIs) aimed at reducing the risk factors associated with depression, anxiety, and eating disorders. The effectiveness will be measured through questionnaires administered before, immediately after, and three months post-intervention.

How Is the Trial Designed?

Group I: Project YES Experimental Treatment 1 Intervention

This is a digital, self-guided SSI that has 3 options, Project Personality, Project CARE, and the ABC project. These teach adolescents about CBT skills including growth mindset, neutral self-talk and behavioral activation. Each option contains self-reflection exercises, vignettes from fictional peers, and psychoeducation that support users in understanding each CBT skill. See all materials for this intervention here: https://www.schleiderlab.org/yes.html

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

The MoodHwb program, designed with input from young people at risk of depression, aims to support their mood and well-being, and is currently being refined based on user feedback before a larger trial.

A multicentre feasibility randomized controlled trial will assess the acceptability and effectiveness of MoodHwb compared to a digital information pack, involving up to 120 participants aged 13-19, with outcomes measured two months post-randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol. Bevan Jones, R., Merry, S., Stallard, P., et al.[2023]

A study analyzing 720 cases of esketamine-related neurological adverse events (AEs) from 2019 to 2021 identified 21 safety signals, with sedation being the most concerning (ROR of 204.00), indicating potential long-term safety issues with esketamine.

The severity of neurological AEs was influenced by factors such as esketamine dosage and co-prescription with other medications, highlighting the need for careful monitoring and management of these risks in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological Adverse Events Associated With Esketamine: A Disproportionality Analysis for Signal Detection Leveraging the FDA Adverse Event Reporting System. Guo, H., Wang, B., Yuan, S., et al.[2022]

A review of 10 clinical trials on esketamine for resistant depression found that 90% of the trials had low-quality reporting of adverse events (AEs), indicating significant gaps in safety data.

The study revealed that 41.5% of serious AEs and 39% of non-serious AEs were not reported in published articles, particularly psychiatric and cardiovascular events, suggesting that the assessment of esketamine's risk-benefit balance may be inaccurate due to incomplete harm reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of harms in clinical trials of esketamine in depression: a systematic review. Taillefer de Laportalière, T., Jullien, A., Yrondi, A., et al.[2023]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

The transdiagnostic EMOTION program, a preventive cognitive behavioral therapy for children aged 8-12, demonstrated significant long-term reductions in self-reported anxious symptoms and parental reports of both anxious and depressive symptoms after 12 months, based on a study involving 795 children.

While the intervention effectively reduced anxiety symptoms, the results for depressive symptoms were less conclusive, as only parental reports indicated a reduction, suggesting further investigation is needed for the efficacy on self-reported depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. Loevaas, MES., Lydersen, S., Sund, AM., et al.[2023]

A self-guided, web-based program aimed at preventing anxiety and depression was tested with 651 university students over eight weeks, focusing on mental health skills like mindfulness and behavioral activation.

While 73% of students started the program, only 11% completed it, indicating a need for improvements; however, 71% found the program useful, suggesting potential for further development and refinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a web-based program for universal prevention of anxiety and depression in university students: An open trial. Rith-Najarian, LR., Chorpita, BF., Gong-Guy, E., et al.[2022]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

Citations

1. schleiderlab.org schleiderlab.org/yes.html

Project YES Project YES (Youth Empowerment & Support) offers free, anonymous, brief, self-guided mental health tools for teens.

2. schleiderlab.org schleiderlab.org/project-personality.html

Project Personality Teens who tried Project Personality have reported improvements in hopelessness, self-hatred, perceived control, agency, depression symptoms, anxiety symptoms, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9975917/

A Digital Single-Session Intervention Platform for Youth ... Project YES is an open-access, anonymous platform containing 3 evidence-based, self-guided interventions for youth mental health.

4. blueprintsprograms.org blueprintsprograms.org/programs/1449999999/project-personality/print/

Project Personality The program focuses on reducing distress generated from internalizing that leads to anxiety and depression by increasing perceived behavioral and emotional ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1054139X25002277

Digital Interventions for Anxiety and Depressive Symptoms ... This review looked at the effectiveness and real-world impact of online programs designed to help adolescents with low mood and anxiety.

6. withpower.com withpower.com/trial/project-yes-for-depression-and-anxiety-7e2e3

Project YES for Depression and Anxiety · Info for Participants This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults.

7. nature.com nature.com/articles/s41562-021-01235-0

A randomized trial of online single-session interventions for ... Third, this study supports acceptability and effectiveness for brief, self-guided depression interventions among highly diverse adolescents.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881339/

A Randomized Trial of Online Single Session Interventions ... The first is a growth mindset (GM-)SSI, an online program teaching that personal traits are malleable, which has prevented and reduced adolescent depression in ...