Mobile Intervention for Suicidal Thoughts

Not Applicable

Not yet recruiting

• Conditions: Suicide
• Interventions: Behavioral: Safety planning; Behavioral: Treatment as usual; Behavioral: MIST Intervention

• Registration Number: NCT06593379
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Study Start: 2025-06-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safety planning, treatment as usual, and MIST	Safety planning	Participants will get a safety plan, treatment as usual, and the MIST intervention.
Safety planning, treatment as usual, and MIST	Treatment as usual	Participants will get a safety plan, treatment as usual, and the MIST intervention.
Safety planning, treatment as usual, and MIST	MIST Intervention	Participants will get a safety plan, treatment as usual, and the MIST intervention.
Safety planning and treatment as usual	Safety planning	Participants will get a safety plan and treatment as usual.
Safety planning and treatment as usual	Treatment as usual	Participants will get a safety plan and treatment as usual.

Primary Outcome Measures

Name	Time	Method
Number of participants recruited	Through 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 intervention	Post-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 Questionnaire	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.
MIST intervention utilization	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.

Trial Locations

Locations (1)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States