- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365579
Design and Feasibility of an SMS-based Safety Planning Intervention
mHealth for Suicide Prevention: Design, Development, and Feasibility of a Scalable SMS-based Safety Planning Intervention
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonah Meyerhoff, PhD
- Phone Number: 312-503-1232
- Email: jonah.meyerhoff@northwestern.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SMS based safety planning intervention (SMS-SPI)
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.
|
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.
|
|
Active Comparator: Enhanced waitlist control (eWLC)
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.
|
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.
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of suicidal thoughts
Time Frame: enrollment to 4 weeks
|
The number of times an individual has experienced suicidal thoughts
|
enrollment to 4 weeks
|
|
Frequency of suicidal behaviors
Time Frame: enrollment to 4 weeks
|
Frequency of suicidal behaviors
|
enrollment to 4 weeks
|
|
Severity of suicidal thoughts
Time Frame: enrollment to 4 weeks
|
Severity of suicidal thoughts
|
enrollment to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS Social Isolation - CAT
Time Frame: Enrollment to 4 weeks
|
Brief measure of Social Isolation
|
Enrollment to 4 weeks
|
|
After-Scenario Questionnaire (ASQ)
Time Frame: enrollment to 4 weeks
|
Brief measure assessing ease of use of the technology
|
enrollment to 4 weeks
|
|
Unbearable Psychache Scale (UP3)
Time Frame: enrollment to 4 weeks
|
Measure of psychic pain.
Range 3-15.
Higher scores indicate worse psychological pain.
|
enrollment to 4 weeks
|
|
Beck Hopelessness Scale-Short Form (BHS-SF)
Time Frame: Enrollment to 4 weeks
|
Brief measure of hopelessness.
Items rated 1 or 0. Scores range from 0-4, with higher scores indicating more hopelessness.
|
Enrollment to 4 weeks
|
|
Suicide Capacity Scale (SC3)
Time Frame: enrollment to 4 weeks
|
Brief measure assessing subjective capacity to engage in suicide.
Scores range from 0-36.
Higher scores indicate greater suicide capacity
|
enrollment to 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicide Related Coping Scale
Time Frame: Enrollment to 4 weeks
|
Suicide Related Coping measure ranging from 0-68, higher scores indicate greater suicide related coping.
|
Enrollment to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonah Meyerhoff, PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00217191
- K08MH128640 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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