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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms.

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 data supports the effectiveness of the treatment Project YES for Depression and Anxiety?

Research shows that using measurement-based care programs, like VitalSign6, in primary care can significantly reduce depression symptoms. Additionally, brief cognitive behavioral therapy, which is a component of many treatments for depression and anxiety, has been shown to be effective in primary care settings. ^{1 2 3 4 5}

Is the treatment in Project YES generally safe for humans?

The safety data for esketamine, a treatment evaluated in some trials, shows concerns about neurological side effects like sedation and dizziness. However, in psychosocial therapy trials, no serious adverse events were linked to the study treatments, suggesting they are generally safe. ^{6 7 8 9 10}

How is Project YES for Depression and Anxiety different from other treatments?

Project YES for Depression and Anxiety may involve a unique approach, possibly incorporating internet-based or digital elements, similar to other programs that use online platforms to deliver mental health skills like mindfulness and behavioral activation. This could make it more accessible and flexible compared to traditional in-person therapies. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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2. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Depression Screening and Measurement-Based Care in Primary Care. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Population-based care of depression: team care approaches to improving outcomes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Neurological Adverse Events Associated With Esketamine: A Disproportionality Analysis for Signal Detection Leveraging the FDA Adverse Event Reporting System. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Reporting of harms in clinical trials of esketamine in depression: a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

11. Australia pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. [2022]

12. England 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a web-based program for universal prevention of anxiety and depression in university students: An open trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Research Review: The internalizing paradox - youth anxiety and depression symptoms, psychotherapy outcomes, and implications for research and practice. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol. [2023]