Chatbot Intervention for Depression

(SMILEY Trial)

Recruiting 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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This feasibility pilot trial seeks to examine the feasibility and target engagement of a coping skills and psychoeducational intervention delivered via an automated conversational chatbot named SMILEY in reducing frequency and stress associated with online victimization among marginalized youth, including those who are Black, Hispanic, and LGBTQ+, and experiencing depression and online victimization. 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 depression and online victimization. Participants will engage with materials, including interactive web resources, to learn safe social media practices and provide coping skills for experiencing online victimization. These materials will cover topics such as managing online time, addressing negative comments, and fostering positive connections. Participants will interact with SMILEY at their own pace over 4 weeks. This interaction will provide information and guidance on dealing with online victimization and the associated stress.

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 data supports the effectiveness of the treatment SMILEY for depression?

Research shows that chatbots and virtual agents can be helpful for managing depression, with patients finding them easy to use and often preferring them over traditional methods. Automated web-based interventions for depression have shown similar effectiveness to those with human support, suggesting that SMILEY could be effective as well. ^{1 2 3 4 5}

Is the chatbot intervention for depression safe for humans?

The research does not provide specific safety data for chatbot interventions for depression, but chatbots are generally considered acceptable and helpful for managing mental health. ^{1 6 7 8 9}

How does the SMILEY treatment for depression differ from other treatments?

The SMILEY treatment is unique because it uses a chatbot to provide support for depression, offering an interactive and automated way to help manage symptoms. This approach is novel as it can be accessed anytime, making it a flexible and cost-effective option compared to traditional therapy sessions. ^{2 10 11 12 13}

Research Team

César G Escobar-Viera, MD, PhD

Principal Investigator

University of Pittsburgh

Candice Biernesser, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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 between 12 and 18 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of chatbot-delivered interventions for self-management of depression: Content analysis. [2022]

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

Pilot randomised controlled trial of Help4Mood, an embodied virtual agent-based system to support treatment of depression. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Response to a Relational Agent by Hospital Patients with Depressive Symptoms. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Comparing human and automated support for depression: Fractional factorial randomized controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Psychosocial implications of avatar use in supporting therapy for depression. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Patient experience of computerised therapy for depression in primary care. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

The interpersonal adverse effects reported by 1008 users of antidepressants; and the incremental impact of polypharmacy. [2018]

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

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Adverse effects and treatment satisfaction among online users of four antidepressants. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A chatbot-based intervention with ELME to improve stress and health-related parameters in a stressed sample: Study protocol of a randomised controlled trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A fully automated conversational agent for promoting mental well-being: A pilot RCT using mixed methods. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Mental Health Chatbot for Young Adults With Depressive Symptoms During the COVID-19 Pandemic: Single-Blind, Three-Arm Randomized Controlled Trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Chatbot features for anxiety and depression: A scoping review. [2023]