Mobile Intervention for Suicidal Thoughts

October 14, 2025 updated by: VA Office of Research and Development

Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions that been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions, including hopelessness, thwarted belongingness, perceived burdensomeness, unlovability, unbearability, and unsolvability. These cognitions have all been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

The investigators will conduct a pilot randomized controlled trial (RCT), in which 50 Veterans with suicidal ideation will be randomized to either MIST plus Treatment as Usual and Safety Planning versus Treatment as Usual and Safety Planning. The central hypothesis is that Veterans will find MIST acceptable and will be willing to use it to reduce their suicidal thoughts.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Recruiting
        • Durham VA Medical Center, Durham, NC
        • Contact:
        • Principal Investigator:
          • Kirsten H Dillon, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans using the Durham VA Health Care System
  • Endorsing suicidal ideation without intent in the last 30 days, established via C-SSRS
  • Meet at least every 4 months with a mental health provider, established via chart review chart
  • Can read at least 6th grade level material, established by their demonstrated ability to read the consent form and answer basic questions about it

Exclusion Criteria:

  • Currently in a period of active psychosis or mania, established via the SCID-5
  • Currently meeting criteria for a moderate or severe alcohol or substance use disorder, established via the SCID-5
  • Endorsing suicidal intent, established via C-SSRS
  • Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
  • Have used the MIST intervention before as part of another research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety planning, treatment as usual, and MIST
Participants will get a safety plan, treatment as usual, and the MIST intervention.
Behavioral: Safety planning
Safety planning (SP) is a single-session intervention that consists of developing a written list of individualized coping strategies and sources of support that can be used during a suicidal crisis.
Behavioral: Treatment as usual
This will include continued care with any of the Veterans' current providers. Study staff will also place appropriate referrals for Veterans, as needed (e.g., Trauma Recovery Program referrals for Veterans with PTSD, Sleep Psychology referrals for Veterans with insomnia). Participants will be encouraged to follow up with their providers' recommendations and treatment plans
Behavioral: MIST Intervention
This is a mobile intervention designed to target and modify suicidal cognitions. Veteran in this condition will be asked to use the intervention 5 times a week for 4 weeks.
Active Comparator: Safety planning and treatment as usual
Participants will get a safety plan and treatment as usual.
Behavioral: Safety planning
Safety planning (SP) is a single-session intervention that consists of developing a written list of individualized coping strategies and sources of support that can be used during a suicidal crisis.
Behavioral: Treatment as usual
This will include continued care with any of the Veterans' current providers. Study staff will also place appropriate referrals for Veterans, as needed (e.g., Trauma Recovery Program referrals for Veterans with PTSD, Sleep Psychology referrals for Veterans with insomnia). Participants will be encouraged to follow up with their providers' recommendations and treatment plans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants recruited
Time Frame: Through study completion (approximately 18 months)
Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Through study completion (approximately 18 months)
Percentage of enrolled participants who complete the study intervention
Time Frame: Post-treatment visit (approximately one month after enrollment)
Treatment retention feasibility goal will be met if attrition is no more than 25%.
Post-treatment visit (approximately one month after enrollment)
Patient satisfaction for MIST app: Client Satisfaction Questionnaire
Time Frame: Post-treatment visit (approximately one month after enrollment)
Patient satisfaction will be assessed with item #7 from the Client Satisfaction Questionnaire. This item is scored on a scale of 1 to 4, with one indicating lower satisfaction and 4 indicating greater satisfaction. The patient satisfaction goal will be met if 80% or greater of participants indicate score a 3 or 4 on this item.
Post-treatment visit (approximately one month after enrollment)
MIST intervention utilization
Time Frame: Post-MIST assessment visit (approximately one month after enrollment)
MIST utilization goal will be met if MIST app utilization rates are greater than 50% of expected use.
Post-MIST assessment visit (approximately one month after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5137-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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