DepressionSMILEYNCT06835985
Social Media Intervention for Online Victimized Youth
A study testing Chatbot Intervention and Brief Psychoeducation in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- Chatbot Intervention and Brief Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents age 12-18
- Current moderate to severe depression (PHQ-9-M ≥ 11)
- 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.
Who cannot join
- Conditions that might impair their ability to effectively deploy interventions, including current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure
- Referring providers will be advised that adolescents must be capable of safely participating, specifically that they do not need urgent medical or psychiatric treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Western Psychiatric Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: sIRB: Social Media Intervention for Online Victimized Youth
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.
Read more
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.
Read the detailed description
This study proposes to determine the feasibility and target engagement of a specialized chatbot intervention named SMILEY in reducing online victimization and stress 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.
Pilot trial: Randomizing 2 to 1 in this study using Efron\'s biased coin toss procedure. Age groups will be balanced (12-14 years old versus 15-18 years old) given that the nature of online victimization and platforms on which it occurs differ across adolescent development, racial/ethnic minority backgrounds, and sexual and gender minority backgrounds.
Sample size and power considerations: Participants (n=75; 2:1 randomization) will be identified during screening for the ETUDES Center Primary Care Study who meet inclusion criteria.
Participant groups:
- Intervention Group: Participants will engage with SMILEY for support, in addition to receiving brief psychoeducation.
- Control Group: Participants will only receive brief psychoeducation, without access to SMILEY
In support of the feasibility of recruitment, among patients with a PHQ-9-M scores ≥ 11 in our specialty mental health clinic for depression, 25% reported at least one OV event in the past month. Participants will be 35% Black and 10% Hispanic; given previous research, investigators expect 30% will identify as SGM. To safeguard privacy for SGM adolescents who are not out to caregivers, SGM identity will be assessed with the adolescent alone and it is not an inclusion criterion for this study. Exclusion criteria for youth are the same as for the ETUDES Center Primary Care Study, namely, mania, psychosis, developmental disability precluding comprehension of study procedures, and lack of English fluency.
Investigators anticipate that feasibility will be high (completion 50%; attrition 20%, ratings 80%); acceptability (ratings 80%); appropriateness (ratings 80%). Youth who receive SMILEY will show greater reductions in perceived stress related to OV (secondary outcome). Improvements in depression severity and risk for STB (tertiary outcomes) will be greater among youth randomized to SMILEY. Outcomes will be equitable by race and SGM identity. Exploratory (mechanistic): SMILEY will lead to decreased STB risk through improved social media self-efficacy and distress tolerance.
Intervention Delivery: Self-paced interaction with the SMILEY chatbot over 4 weeks. A research clinician will provide psychoeducation for youth and caregivers using web resources. Topics include social media self-efficacy (e.g., screen time management and positive online interactions) and guidance on how to respond to and cope with online victimization. Though usage and interactions will be self-paced, investigators expect participants will engage 2-3 times per week, for 5-10 minutes each session. Participants may receive reminders from the chatbot to engage, and if inactive for 1 week, a research assistant will assist with technical issues. Reports summarizing content may be provided to adolescents, caregivers, and providers at the end of the intervention.
- Conditions
- Depression, Suicidal Ideation
- Being tested
- Chatbot Intervention, Brief Psychoeducation
- Keywords
- online victimization, chatbot, social media intervention
- Medical subject headings
- Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot InterventionOther
Also called SMILEY
Participants screened for suicidality during the ETUDES Center Primary Care Study and who disclose experiencing online victimization will be onboarded by a research clinician on how to use SMILEY, the web-based intervention that delivers psychoeducation, basic concepts of social media self-efficiency, and guidance on how to respond to and cope with online victimization. The chatbot and/or research clinician will send out periodic reminders to users to remind them to engage with the chatbot over four weeks. Technical troubleshooting concerns will be carried out by research clinician and chatbot developer team.
Brief PsychoeducationOther
When youth onboard the study, a 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.
| Study group | Role | What they receive |
|---|---|---|
| SMILEY + Brief Psychoeducation | Experimental | 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. Receives: Other: Chatbot Intervention; Other: Brief Psychoeducation |
| Brief Psychoeducation | Active comparator | 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. Receives: Other: Brief Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with the chatbot
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Measured: Baseline
Engagement with the chatbot
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Measured: 1 month
Engagement with the chatbot
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Measured: 3 months
Engagement with the chatbot
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Measured: 6 months
Engagement with the chatbot
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Measured: 12 months
Perceived satisfaction of the chatbot
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Measured: Baseline
Perceived satisfaction of the chatbot
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Measured: 1 month
Perceived satisfaction of the chatbot
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Measured: 3 months
Perceived satisfaction of the chatbot
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Measured: 6 months
Perceived satisfaction of the chatbot
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Measured: 12 months
Secondary outcomes (10)
Levels of general self-efficacy
Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.
Measured: Baseline
Levels of general self-efficacy
Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.
Measured: 1 month
Levels of general self-efficacy
Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.
Measured: 3 months
Levels of general self-efficacy
Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.
Measured: 6 months
Levels of general self-efficacy
Levels of general self-efficacy will be measured by the General Self-Efficacy Scale (GSE). Response options and scores include: "Not at all true (1)," "Hardly true (2)," "Moderately true," and "Exactly true (4)." Scores range from 10 to 40, with higher scores indicating higher levels of self-efficacy and lower scores indicating lower levels of self-efficacy.
Measured: 12 months
Levels of distress tolerance
Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Measured: Baseline
Levels of distress tolerance
Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Measured: 1 month
Levels of distress tolerance
Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Measured: 3 months
Levels of distress tolerance
Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Measured: 6 months
Levels of distress tolerance
Levels of distress tolerance will be measured by the Distress Tolerance Scale (DTS). Response options and scores include: "Strongly Disagree (1)," "Mildly Disagree (2)," "Agree and Disagree Equally (3)," "Mildly Agree (4)," and "Strongly Agree (5)." Scores range from 1 to 5, with higher scores indicating higher levels of distress tolerance and lower scores indicating lower levels of distress tolerance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start6 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will only be assigned to one of two interventions to compare SMILEY + brief psychoeducation (intervention) vs. brief psychoeducation (control).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Children's Hospital of Philadelphia, University of Oregon
- Responsible party
- Principal investigator, César Escobar-Viera, University of Pittsburgh
- Investigators
- César G Escobar-Viera, MD, PhD, Principal investigator, University of PittsburghCandice Biernesser, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835985
- Sponsor's protocol ID
- STUDY22040038
- Other IDs
- P50MH115838
- Acronym
- SMILEY
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with the NIMH's data sharing and data use policies this research study and clinical trial will be compliant with requirements for depositing data with the NIMH Data Archive (NDA) in the National Database for Clinical Trials Related to Mental Illness (NDCT). Specific statements will be added to the consent forms to allow for data sharing. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sIRB: Social Media Intervention for Online Victimized Youth
- ClinicalTrials.gov ID
- NCT06835985
- Acronym / sponsor ID
- SMILEY / STUDY22040038
- Conditions
- Depression, Suicidal Ideation
- Keywords
- online victimization, chatbot, social media intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Children's Hospital of Philadelphia, University of Oregon
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study proposes to determine the feasibility and target engagement of a specialized chatbot intervention named SMILEY in reducing online victimization and stress 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.
Pilot trial: Randomizing 2 to 1 in this study using Efron\'s biased coin toss procedure. Age groups will be balanced (12-14 years old versus 15-18 years old) given that the nature of online victimization and platforms on which it occurs differ across adolescent development, racial/ethnic minority backgrounds, and sexual and gender minority backgrounds.
Sample size and power considerations: Participants (n=75; 2:1 randomization) will be identified during screening for the ETUDES Center Primary Care Study who meet inclusion criteria.
Participant groups:
- Intervention Group: Participants will engage with SMILEY for support, in addition to receiving brief psychoeducation.
- Control Group: Participants will only receive brief psychoeducation, without access to SMILEY
In support of the feasibility of recruitment, among patients with a PHQ-9-M scores ≥ 11 in our specialty mental health clinic for depression, 25% reported at least one OV event in the past month. Participants will be 35% Black and 10% Hispanic; given previous research, investigators expect 30% will identify as SGM. To safeguard privacy for SGM adolescents who are not out to caregivers, SGM identity will be assessed with the adolescent alone and it is not an inclusion criterion for this study. Exclusion criteria for youth are the same as for the ETUDES Center Primary Care Study, namely, mania, psychosis, developmental disability precluding comprehension of study procedures, and lack of English fluency.
Investigators anticipate that feasibility will be high (completion 50%; attrition 20%, ratings 80%); acceptability (ratings 80%); appropriateness (ratings 80%). Youth who receive SMILEY will show greater reductions in perceived stress related to OV (secondary outcome). Improvements in depression severity and risk for STB (tertiary outcomes) will be greater among youth randomized to SMILEY. Outcomes will be equitable by race and SGM identity. Exploratory (mechanistic): SMILEY will lead to decreased STB risk through improved social media self-efficacy and distress tolerance.
Intervention Delivery: Self-paced interaction with the SMILEY chatbot over 4 weeks. A research clinician will provide psychoeducation for youth and caregivers using web resources. Topics include social media self-efficacy (e.g., screen time management and positive online interactions) and guidance on how to respond to and cope with online victimization. Though usage and interactions will be self-paced, investigators expect participants will engage 2-3 times per week, for 5-10 minutes each session. Participants may receive reminders from the chatbot to engage, and if inactive for 1 week, a research assistant will assist with technical issues. Reports summarizing content may be provided to adolescents, caregivers, and providers at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will only be assigned to one of two interventions to compare SMILEY + brief psychoeducation (intervention) vs. brief psychoeducation (control).
| Arm | Type | Receives |
|---|---|---|
| SMILEY + Brief Psychoeducation | Experimental | Other: Chatbot Intervention, Other: Brief PsychoeducationSMILEY (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. |
| Brief Psychoeducation | Active comparator | Other: Brief PsychoeducationResearch 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 may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents age 12-18
- Current moderate to severe depression (PHQ-9-M ≥ 11)
- 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.
Key exclusion criteria (2 listed)
- Conditions that might impair their ability to effectively deploy interventions, including current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure
- Referring providers will be advised that adolescents must be capable of safely participating, specifically that they do not need urgent medical or psychiatric treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot InterventionAlso: SMILEYParticipants screened for suicidality during the ETUDES Center Primary Care Study and who disclose experiencing online victimization will be onboarded by a research clinician on how to use SMILEY, the web-based intervention that delivers psychoeducation, basic concepts of social media self-efficiency, and guidance on how to respond to and cope with online victimization. The chatbot and/or research clinician will send out periodic reminders to users to remind them to engage with the chatbot over four weeks. Technical troubleshooting concerns will be carried out by research clinician and chatbot developer team. | Other | SMILEY + Brief Psychoeducation |
| Brief PsychoeducationWhen youth onboard the study, a 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. | Other | Brief Psychoeducation, SMILEY + Brief Psychoeducation |
Primary outcome
Engagement with the chatbot
Time frame: Baseline
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Engagement with the chatbot
Time frame: 1 month
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Engagement with the chatbot
Time frame: 3 months
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Engagement with the chatbot
Time frame: 6 months
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Engagement with the chatbot
Time frame: 12 months
Engagement will be measured by the timestamps of usage of the intervention. Timestamps will be generated when there is a message from the user and a corresponding message from the chatbot.
Perceived satisfaction of the chatbot
Time frame: Baseline
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Perceived satisfaction of the chatbot
Time frame: 1 month
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Perceived satisfaction of the chatbot
Time frame: 3 months
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Perceived satisfaction of the chatbot
Time frame: 6 months
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
Perceived satisfaction of the chatbot
Time frame: 12 months
Perceived satisfaction of the chatbot will be measured by the Post-Study System Usability Questionnaire (PSSUQ). Response options and scores include: "Strongly Agree (1)" to "Strongly Disagree (7)." Scores range from 1 to 7, with higher scores indicating lower levels of satisfaction and lower scores indicating higher levels satisfaction.
10 secondary outcomes
Levels of general self-efficacy
Time frame: Baseline
Levels of general self-efficacy
Time frame: 1 month
Levels of general self-efficacy
Time frame: 3 months
Levels of general self-efficacy
Time frame: 6 months
Levels of general self-efficacy
Time frame: 12 months
Levels of distress tolerance
Time frame: Baseline
Levels of distress tolerance
Time frame: 1 month
Levels of distress tolerance
Time frame: 3 months
Levels of distress tolerance
Time frame: 6 months
Levels of distress tolerance
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Consistent with the NIMH's data sharing and data use policies this research study and clinical trial will be compliant with requirements for depositing data with the NIMH Data Archive (NDA) in the National Database for Clinical Trials Related to Mental Illness (NDCT). Specific statements will be added to the consent forms to allow for data sharing. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
César G Escobar-Viera, MD, PhD principal investigator
University of Pittsburgh
Candice Biernesser, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot Intervention and Brief Psychoeducation in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with the chatbot (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.