Suicidal Ideation and BehaviorNCT07365579
Design and Feasibility of an SMS-based Safety Planning Intervention
A study testing Text Messaging based Safety Planning Intervention and Facilitated Referral to Crisis Resources in people with Suicidal Ideation and Behavior, run by Northwestern University at 1 site in United States.
Trial summary
This study is testing whether it is feasible to run a larger randomized controlled trial and whether an automated text messaging program is acceptable to young adults who have suicidal thoughts. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Suicidal Ideation and Behavior
- What is being tested?
- Text Messaging based Safety Planning Intervention and Facilitated Referral to Crisis Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to 30 Jun 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 to 24 *The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.
- endorsement of past 2-week suicidal ideation
- Resident of the United States
- Owns a smartphone
Who cannot join
- Serious mental illness for which intervention would be contraindicated (i.e., active psychosis or mania)
- Imminent suicidality (i.e., experiencing active suicidal ideation with a plan and intent to act)
- Written English language skills that are insufficient to engage in the consent, design, evaluation, or intervention procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Jonah Meyerhoff, PhD, 3125031232, jonah.meyerhoff@northwestern.edu
Jonah Meyerhoff, PhD
About this study
Official title: mHealth for Suicide Prevention: Design, Development, and Feasibility of a Scalable SMS-based Safety Planning Intervention
This study is testing whether it is feasible to run a larger randomized controlled trial and whether an automated text messaging program is acceptable to young adults who have suicidal thoughts. The program is designed to help participants create and use a safety plan, which is a personalized list of warning signs, coping strategies, supportive people, professional resources, ways to make their environment safer, and reasons for living. After joining and completing an initial survey, participants are randomly assigned by a computer to one of two groups. One group starts right away with the interactive safety planning text program. The other group first receives simple text messages with 24/7 crisis resources and then, after four weeks, also receives the interactive safety planning program. Participants use the text program for about four weeks and complete online surveys at the start and again over a total period of 24 weeks.
Read the detailed description
This study is a randomized, controlled feasibility trial testing an automated text messaging program designed to help young adults (ages 18 to 24) who have recently experienced suicidal thoughts create and use a personalized safety plan. A safety plan is a step-by-step list of warning signs, coping strategies, supportive people, professional resources, ways to make the environment safer, and personal reasons for living that can be used during times of crisis. The main goals of the study are not to prove effectiveness or efficacy, but to determine whether it is possible to run a larger randomized controlled trial in the future and whether young adults find this type of text-based safety planning acceptable, usable, and engaging.
Sixty participants will be enrolled from across the United States through Mental Health America and online outreach. After completing screening, providing consent, finishing baseline surveys, and confirming they can receive text messages, participants will be randomly assigned by a computer, like flipping a coin, to one of two groups. Neither participants nor study staff choose the group assignment. One group will receive the interactive safety-planning text program right away. The other group will first receive supportive but non-interactive text messages that provide 24/7 crisis resources, and after four weeks will also begin the same interactive safety-planning program. This "enhanced waitlist" design allows all participants to eventually receive the intervention while still allowing researchers to compare early outcomes between groups.
The interactive program lasts four weeks and sends daily text messages that guide users through building and practicing their safety plan. Messages ask participants to reflect on their own experiences, write responses in their own words, identify coping activities, supportive people, crisis services, and ways to reduce access to dangerous means. The system uses follow-up questions and branching logic so that each person's safety plan becomes detailed and highly personalized. Participants can also review and update their plan through a secure web link and can request different modules on demand. After the four-week active phase, participants can continue to access their safety plan for the rest of the 24-week study period.
Throughout the study, participants complete online surveys at the start and again at 2, 4, 8, 16, and 24 weeks. These surveys measure suicidal thoughts and behaviors, coping skills, emotional pain, hopelessness, social connection, and how acceptable and helpful the text program feels. A key focus is whether participants stay engaged, complete assessments, and find the intervention useful and safe, which are critical indicators of feasibility and acceptability for a future larger trial.
- Conditions
- Suicidal Ideation and Behavior
- Being tested
- Text Messaging based Safety Planning Intervention, Facilitated Referral to Crisis Resources
- Keywords
- Text message, safety plan, suicide prevention
- Medical subject headings
- Suicidal Ideation, Behavior, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging based Safety Planning InterventionBehavioural
A 4-week automated text messaging intervention designed to guide users through the steps of the safety planning process. The intervention delivers structured, interactive messages daily addressing coping strategies, crisis resources, environmental safety, family and friends for support, distraction techniques, and recognition of warning signs.
Facilitated Referral to Crisis ResourcesBehavioural
Text messages that are non-interactive and contain referral to crisis services (e.g., the National Suicide Prevention Lifeline, the Crisis Text Line, and (c) the Trevor Project Lifeline).
| Study group | Role | What they receive |
|---|---|---|
| SMS based safety planning intervention (SMS-SPI) | Experimental | The SMS-SPI consists of a 4-week automated text messaging intervention. It is designed to guide users through the steps of the safety planning process for management of suicide related thoughts and behaviors. The intervention delivers structured, interactive messages daily addressing coping strategies, crisis resources, environmental safety, family and friends for support, distraction techniques, and recognition of warning signs. The number of messages sent each day varies based on users' interactions with the program; users who respond more frequently may receive more messages. In addition to text messaging, the program includes a web-based interface that enabled users to conveniently review and update their safety plan. The SMS-SPI uses message stems that establish a particular topic (e.g., identification of crisis warning signs) and message probes that follow-up on users' responses, which is individualized through branching logic. Receives: Behavioral: Text Messaging based Safety Planning Intervention |
| Enhanced waitlist control (eWLC) | Active comparator | Text messages that are non-interactive and contain referral to crisis services (e.g., the National Suicide Prevention Lifeline, the Crisis Text Line, and (c) the Trevor Project Lifeline). Facilitated referral is a first-line prevention strategy for suicide and is a best-practice commonly integrated into internet-based screenings and informational tools. Receives: Behavioral: Text Messaging based Safety Planning Intervention; Behavioral: Facilitated Referral to Crisis Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of suicidal thoughts
The number of times an individual has experienced suicidal thoughts
Measured: enrollment to 4 weeks
Frequency of suicidal behaviors
Frequency of suicidal behaviors
Measured: enrollment to 4 weeks
Severity of suicidal thoughts
Severity of suicidal thoughts
Measured: enrollment to 4 weeks
Secondary outcomes (5)
Unbearable Psychache Scale (UP3)
Measure of psychic pain. Range 3-15. Higher scores indicate worse psychological pain.
Measured: enrollment to 4 weeks
Beck Hopelessness Scale-Short Form (BHS-SF)
Brief measure of hopelessness. Items rated 1 or 0. Scores range from 0-4, with higher scores indicating more hopelessness.
Measured: Enrollment to 4 weeks
PROMIS Social Isolation - CAT
Brief measure of Social Isolation
Measured: Enrollment to 4 weeks
Suicide Capacity Scale (SC3)
Brief measure assessing subjective capacity to engage in suicide. Scores range from 0-36. Higher scores indicate greater suicide capacity
Measured: enrollment to 4 weeks
After-Scenario Questionnaire (ASQ)
Brief measure assessing ease of use of the technology
Measured: enrollment to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Jun 2026
- Primary completion4 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Ideation and BehaviorStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- enhanced waitlist control design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jonah Meyerhoff, Northwestern University
- Investigators
- Jonah Meyerhoff, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365579
- Sponsor's protocol ID
- STU00217191
- Other IDs
- K08MH128640
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth for Suicide Prevention: Design, Development, and Feasibility of a Scalable SMS-based Safety Planning Intervention
- ClinicalTrials.gov ID
- NCT07365579
- Acronym / sponsor ID
- STU00217191
- Conditions
- Suicidal Ideation and Behavior
- Keywords
- Text message, safety plan, suicide prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Jan 2026 (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 study is testing whether it is feasible to run a larger randomized controlled trial and whether an automated text messaging program is acceptable to young adults who have suicidal thoughts. The program is designed to help participants create and use a safety plan, which is a personalized list of warning signs, coping strategies, supportive people, professional resources, ways to make their environment safer, and reasons for living. After joining and completing an initial survey, participants are randomly assigned by a computer to one of two groups. One group starts right away with the interactive safety planning text program. The other group first receives simple text messages with 24/7 crisis resources and then, after four weeks, also receives the interactive safety planning program. Participants use the text program for about four weeks and complete online surveys at the start and again over a total period of 24 weeks.
Detailed description
This study is a randomized, controlled feasibility trial testing an automated text messaging program designed to help young adults (ages 18 to 24) who have recently experienced suicidal thoughts create and use a personalized safety plan. A safety plan is a step-by-step list of warning signs, coping strategies, supportive people, professional resources, ways to make the environment safer, and personal reasons for living that can be used during times of crisis. The main goals of the study are not to prove effectiveness or efficacy, but to determine whether it is possible to run a larger randomized controlled trial in the future and whether young adults find this type of text-based safety planning acceptable, usable, and engaging.
Sixty participants will be enrolled from across the United States through Mental Health America and online outreach. After completing screening, providing consent, finishing baseline surveys, and confirming they can receive text messages, participants will be randomly assigned by a computer, like flipping a coin, to one of two groups. Neither participants nor study staff choose the group assignment. One group will receive the interactive safety-planning text program right away. The other group will first receive supportive but non-interactive text messages that provide 24/7 crisis resources, and after four weeks will also begin the same interactive safety-planning program. This "enhanced waitlist" design allows all participants to eventually receive the intervention while still allowing researchers to compare early outcomes between groups.
The interactive program lasts four weeks and sends daily text messages that guide users through building and practicing their safety plan. Messages ask participants to reflect on their own experiences, write responses in their own words, identify coping activities, supportive people, crisis services, and ways to reduce access to dangerous means. The system uses follow-up questions and branching logic so that each person's safety plan becomes detailed and highly personalized. Participants can also review and update their plan through a secure web link and can request different modules on demand. After the four-week active phase, participants can continue to access their safety plan for the rest of the 24-week study period.
Throughout the study, participants complete online surveys at the start and again at 2, 4, 8, 16, and 24 weeks. These surveys measure suicidal thoughts and behaviors, coping skills, emotional pain, hopelessness, social connection, and how acceptable and helpful the text program feels. A key focus is whether participants stay engaged, complete assessments, and find the intervention useful and safe, which are critical indicators of feasibility and acceptability for a future larger trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- enhanced waitlist control design
| Arm | Type | Receives |
|---|---|---|
| SMS based safety planning intervention (SMS-SPI) | Experimental | Behavioral: Text Messaging based Safety Planning InterventionThe SMS-SPI consists of a 4-week automated text messaging intervention. It is designed to guide users through the steps of the safety planning process for management of suicide related thoughts and behaviors. The intervention delivers structured, interactive messages daily addressing coping strategies, crisis resources, environmental safety, family and friends for support, distraction techniques, and recognition of warning signs. The number of messages sent each day varies based on users' interactions with the program; users who respond more frequently may receive more messages. In addition to text messaging, the program includes a web-based interface that enabled users to conveniently review and update their safety plan. The SMS-SPI uses message stems that establish a particular topic (e.g., identification of crisis warning signs) and message probes that follow-up on users' responses, which is individualized through branching logic. |
| Enhanced waitlist control (eWLC) | Active comparator | Behavioral: Text Messaging based Safety Planning Intervention, Behavioral: Facilitated Referral to Crisis ResourcesText messages that are non-interactive and contain referral to crisis services (e.g., the National Suicide Prevention Lifeline, the Crisis Text Line, and (c) the Trevor Project Lifeline). Facilitated referral is a first-line prevention strategy for suicide and is a best-practice commonly integrated into internet-based screenings and informational tools. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18 to 24 *The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.
- endorsement of past 2-week suicidal ideation
- Resident of the United States
- Owns a smartphone
Key exclusion criteria (3 listed)
- Serious mental illness for which intervention would be contraindicated (i.e., active psychosis or mania)
- Imminent suicidality (i.e., experiencing active suicidal ideation with a plan and intent to act)
- Written English language skills that are insufficient to engage in the consent, design, evaluation, or intervention procedures.
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 |
|---|---|---|
| Text Messaging based Safety Planning InterventionA 4-week automated text messaging intervention designed to guide users through the steps of the safety planning process. The intervention delivers structured, interactive messages daily addressing coping strategies, crisis resources, environmental safety, family and friends for support, distraction techniques, and recognition of warning signs. | Behavioural | Enhanced waitlist control (eWLC), SMS based safety planning intervention (SMS-SPI) |
| Facilitated Referral to Crisis ResourcesText messages that are non-interactive and contain referral to crisis services (e.g., the National Suicide Prevention Lifeline, the Crisis Text Line, and (c) the Trevor Project Lifeline). | Behavioural | Enhanced waitlist control (eWLC) |
Primary outcome
Frequency of suicidal thoughts
Time frame: enrollment to 4 weeks
The number of times an individual has experienced suicidal thoughts
Frequency of suicidal behaviors
Time frame: enrollment to 4 weeks
Frequency of suicidal behaviors
Severity of suicidal thoughts
Time frame: enrollment to 4 weeks
Severity of suicidal thoughts
5 secondary outcomes
Unbearable Psychache Scale (UP3)
Time frame: enrollment to 4 weeks
Beck Hopelessness Scale-Short Form (BHS-SF)
Time frame: Enrollment to 4 weeks
PROMIS Social Isolation - CAT
Time frame: Enrollment to 4 weeks
Suicide Capacity Scale (SC3)
Time frame: enrollment to 4 weeks
After-Scenario Questionnaire (ASQ)
Time frame: enrollment to 4 weeks
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 25 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jonah Meyerhoff, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging based Safety Planning Intervention and Facilitated Referral to Crisis Resources in people with Suicidal Ideation and Behavior, run by Northwestern University at 1 site 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 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 1 site 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?
Contact Jonah Meyerhoff, PhD (312-503-1232, jonah.meyerhoff@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of suicidal thoughts (time frame: enrollment to 4 weeks). The study lists 3 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 25 Jun 2026.