SuicideNCT06593379
Mobile Intervention for Suicidal Thoughts
A study testing Safety planning, Treatment as usual and MIST Intervention in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Safety planning, Treatment as usual and MIST Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Kirsten H Dillon, PhD, (919) 286-0411, Kirsten.Dillon@va.gov
Angela C Kirby, MS, (919) 286-0411 ext. 7456, angela.kirby@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Safety planning, Treatment as usual, MIST Intervention
- Keywords
- suicide, suicide cognitions, mobile intervention, Veterans
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety planningBehavioural
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.
Treatment as usualBehavioural
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
MIST InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST) | Experimental | Participants will get a safety plan, treatment as usual, and the MIST intervention. Receives: 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. Receives: Behavioral: Safety planning; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Post-MIST assessment visit (approximately one month after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2025
- Primary completion2 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kirsten H Dillon, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593379
- Sponsor's protocol ID
- D5137-P
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT06593379
- Acronym / sponsor ID
- D5137-P
- Conditions
- Suicide
- Keywords
- suicide, suicide cognitions, mobile intervention, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 2 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST) | Experimental | Behavioral: Safety planning, Behavioral: Treatment as usual, Behavioral: MIST InterventionParticipants will get a safety plan, treatment as usual, and the MIST intervention. |
| Safety planning and treatment as usual | Active comparator | Behavioral: Safety planning, Behavioral: Treatment as usualParticipants will get a safety plan and treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety planningSafety 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. | Behavioural | Safety planning and treatment as usual, Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST) |
| Treatment as usualThis 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 | Behavioural | Safety planning and treatment as usual, Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST) |
| MIST InterventionThis 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. | Behavioural | Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST) |
Primary outcome
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.
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%.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten H Dillon, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety planning, Treatment as usual and MIST Intervention in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten H Dillon, PhD ((919) 286-0411, Kirsten.Dillon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: Through study completion (approximately 18 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.