Clinical trial NCT06593379: Mobile Intervention for Suicidal Thoughts
Official title: Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: suicide
suicide cognitions
mobile intervention
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants recruited
timeFrame: Through study completion (approximately 18 months)
measure: Percentage of enrolled participants who complete the study intervention
timeFrame: Post-treatment visit (approximately one month after enrollment)
measure: Patient satisfaction for MIST app: Client Satisfaction Questionnaire
timeFrame: Post-treatment visit (approximately one month after enrollment)
measure: MIST intervention utilization
timeFrame: Post-MIST assessment visit (approximately one month after enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kirsten H Dillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: