Chatbot Intervention for Depression

(SMILEY Trial)

Enrolling by invitation at 1 trial location

Overseen By Emma Win

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Manic, Psychotic, Life-threatening, Intellectual, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an automated chatbot called SMILEY can help marginalized youth experiencing depression and online victimization feel safer and less stressed online. Over four weeks, participants will use SMILEY to learn coping skills and safe social media practices. The trial specifically targets Black, Hispanic, and LGBTQ+ youth who frequently face online harassment and have moderate to severe depression. Youth who often encounter negative online interactions and struggle with depression might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for online safety and mental health.

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 seems focused on using a chatbot for coping skills, so it's unlikely that medication changes are required.

What prior data suggests that the SMILEY chatbot intervention is safe for marginalized youth?

Research has shown that chatbots like SMILEY are generally safe for users. These chatbots often assist teens facing online bullying or discrimination. Although specific safety data for SMILEY is not available, chatbots designed to help with depression typically aim to support users without causing harm. They work to lift mood and help change behaviors linked to depression.

SMILEY operates through social media and supports marginalized youth by teaching skills to handle online negativity and stress. Importantly, chatbots regularly check in with users to ensure they are not in severe distress. This ongoing monitoring helps keep interactions safe.

Overall, even without direct safety data, chatbots like SMILEY are designed to be low-risk and supportive, offering a safe space for teens to learn coping skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SMILEY because it offers a unique approach to managing depression in youth, especially those who face online victimization. Unlike standard treatments like medication or traditional therapy, SMILEY uses a chatbot delivered through Facebook Messenger, making it accessible and engaging for tech-savvy young people. It focuses on improving social media self-efficacy and distress tolerance, addressing the digital challenges these youths face. This innovative delivery method and targeted focus on online interactions set it apart from other depression treatments.

What evidence suggests that SMILEY could be an effective intervention for depression and online victimization?

Research shows that chatbots can help reduce stress. A review of several studies found that these chatbots have a small but meaningful impact on lowering stress levels, indicating their potential to help. For instance, a study on a similar chatbot showed it effectively supported people at high risk for depression. In this trial, participants in one arm will receive the SMILEY intervention, which guides users in dealing with online stress, particularly benefiting young people from marginalized groups. SMILEY teaches coping skills and provides information to help users better manage their online experiences. This suggests that SMILEY could effectively improve safety and reduce stress from online bullying or harassment. ^{1 2 4 5 6}

Who Is on the Research Team?

César G Escobar-Viera, MD, PhD

Principal Investigator

University of Pittsburgh

Candice Biernesser, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for marginalized youth, including Black, Hispanic, and LGBTQ+ individuals who are dealing with depression and have been victimized online. Participants should be experiencing suicidal thoughts or ideation.

Inclusion Criteria

I am currently experiencing moderate to severe depression.

Patients must screen positive for depression, PHQ-9-M score ≥ 11, and online victimization (OV). A positive screen will be OV that occurred 'a few times' for at least one type of OV or 'once' for at least two types of OV.

Exclusion Criteria

I am a teenager who can safely join without needing urgent medical or mental health care.

I do not have any mental health or severe medical conditions that would prevent me from following the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the SMILEY chatbot and receive psychoeducation over 4 weeks

4 weeks

Self-paced interaction, expected 2-3 times per week

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• SMILEY

Trial Overview The trial tests a chatbot named SMILEY that delivers coping skills and psychoeducation to help participants manage the stress of online victimization. Over 4 weeks, they'll learn safe social media practices through interactive materials.

How Is the Trial Designed?

Group I: SMILEY + Brief Psychoeducation Experimental Treatment 2 Interventions

SMILEY (Social Media Intervention for Online Victimized Youth): A self-paced HIPAA-compliant chatbot intervention administered through Facebook Messenger that delivers psychoeducational and coping skills content to improve social media self-efficacy and distress tolerance among Black, SGM and other minority youth with moderate to severe depression who experience online victimization.

Group II: Brief Psychoeducation Active Control 1 Intervention

Research clinician will deliver psychoeducation for youth and caregivers supported by web-based resources. Content will introduce basic concepts of social media self-efficacy (screen time guidance, technological coping skills, and encouragement of positive online interactions) and guidance on how to respond to and cope with online victimization.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Chatbots can effectively support patients with anxiety and depression, serving as affordable and efficient virtual assistants, especially in areas with limited mental health resources.

Out of 42 studies reviewed, about 60% of chatbots targeted both anxiety and depression, indicating their versatility in addressing multiple mental health issues, while their role in mental health care is expected to grow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chatbot features for anxiety and depression: A scoping review. Ahmed, A., Hassan, A., Aziz, S., et al.[2023]

Citations

1. withpower.com withpower.com/trial/chatbot-intervention-for-depression-0b6fb

Chatbot Intervention for Depression (SMILEY Trial) The primary inquiry of this study is whether SMILEY can enhance the safety and decrease stress levels in online environments for marginalized youth coping with ...

2. etudescenter.org etudescenter.org/smiley

Smiley SMILEY is a social media-based chat program for teens ages 13-18 who have had negative online experiences (e.g., bullying, harassment, discrimination, etc.) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12261465/

Chatbot‐Delivered Interventions for Improving Mental ... The meta‐analysis indicated that chatbot‐delivered interventions significantly reduced distress (Hedge's g = −0.28, 95% CI [−0.46, −0.10]), but ...

4. researchgate.net researchgate.net/publication/363718390_Evaluation_of_chatbot-delivered_interventions_for_self-management_of_depression_Content_analysis

(PDF) Evaluation of chatbot-delivered interventions for self- ... This randomized controlled trial evaluated the efficacy, feasibility, and technical outcomes of Amanda, a GPT-4-based chatbot, in delivering ...

5. medinform.jmir.org medinform.jmir.org/2025/1/e63538

Development and Evaluation of a Mental Health Chatbot ... At the baseline of our study with 53 participants, 23 (43.4%, 23/53) were categorized as high-risk for depression. These findings underscore the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12222314/

Persuasive chatbot-based interventions for depression Since chatbots for depression aim at improving symptoms or encourage behavior change, it should be reported how the chatbot is measuring whether ...