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Mobile Intervention for Suicidal Thoughts

Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06593379
Enrollment
50
Registered
2024-09-19
Start date
2025-09-03
Completion date
2027-09-30
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

suicide, suicide cognitions, mobile intervention, Veterans

Brief summary

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.

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.

Interventions

BEHAVIORALSafety 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.

BEHAVIORALTreatment 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

BEHAVIORALMIST 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and outcomes assessors will be blinded to the participant condition.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veterans using the Durham VA Health Care System * Endorsing suicidal ideation without intent in the last 30 days, established via Columbia-Suicide Severity Rating Scale (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 Structured Clinical Interview for DSM-5 (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 Columbia-Suicide Severity Rating Scale (C-SSRS) * Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention * Have used the Mobile Intervention for Suicidal Thoughts (MIST) intervention before as part of another research study

Design outcomes

Primary

MeasureTime frameDescription
Number of participants recruitedThrough study completion (approximately 18 months)Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Percentage of enrolled participants who complete the study interventionPost-treatment visit (approximately one month after enrollment)Treatment retention feasibility goal will be met if attrition is no more than 25%.
Patient satisfaction for MIST app: Client Satisfaction QuestionnairePost-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.
MIST intervention utilizationPost-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.

Countries

United States

Contacts

CONTACTKirsten H Dillon, PhD
Kirsten.Dillon@va.gov(919) 286-0411
CONTACTAngela C Kirby, MS
angela.kirby@va.gov(919) 286-0411
PRINCIPAL_INVESTIGATORKirsten H Dillon, PhD

Durham VA Medical Center, Durham, NC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026