Mobile Intervention for Suicidal Thoughts

NCT06593379 | Recruiting

• 1 other identifier: D5137-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide

Keywords

suicide; suicide cognitions; mobile intervention; veterans

Outcome Measures

Primary Outcomes (4)

• Number of participants recruited

  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

  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

  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

  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)

Study Arms (2)

Safety planning, treatment as usual, and MIST

EXPERIMENTAL

Participants will get a safety plan, treatment as usual, and the MIST intervention.

Behavioral: Safety planning; Behavioral: Treatment as usual; Behavioral: MIST Intervention

Safety planning and treatment as usual

ACTIVE COMPARATOR

Participants will get a safety plan and treatment as usual.

Behavioral: Safety planning; Behavioral: Treatment as usual

Interventions

Safety planning BEHAVIORAL

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.

Safety planning and treatment as usual; Safety planning, treatment as usual, and MIST

Treatment as usual BEHAVIORAL

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

Safety planning and treatment as usual; Safety planning, treatment as usual, and MIST

MIST Intervention BEHAVIORAL

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.

Safety planning, treatment as usual, and MIST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

MeSH Terms

Conditions

Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Kirsten H Dillon, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten H Dillon, PhD

CONTACT

(919) 286-0411; Kirsten.Dillon@va.gov

Angela C Kirby, MS

CONTACT

(919) 286-0411; angela.kirby@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessors will be blinded to the participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)