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Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (COR 19-490)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04881903
Enrollment
10
Registered
2021-05-11
Start date
2021-12-01
Completion date
2024-02-01
Last updated
2025-02-20

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, Anger, Mobile intervention

Brief summary

Suicide cognitions are conceptualized as enduring, chronic vulnerability factors that predispose individuals to suicidal crises. Therefore, modification of these beliefs may reduce suicidal thoughts and behaviors. The goal of this research is to develop, refine, and pilot-test a mobile intervention to reduce cognitions that contribute to elevated suicide risk and to assess the impact of reductions in suicide cognitions and anger cognitions on suicide risk and functioning.

Detailed description

Suicide cognitions are conceptualized as enduring, chronic vulnerability factors that predispose individuals to suicidal crises. Therefore, modification of these beliefs may reduce suicidal thoughts and behaviors. In addition to suicide cognitions, another potentially modifiable risk factor for suicide is anger. The goal of this research is to develop, refine, and pilot-test a mobile interpretation bias modification intervention to reduce cognitions that contribute to elevated suicide risk and to assess the impact of reductions in suicide cognitions and hostile interpretation bias (a cognitive bias that is associated with anger) on suicide risk and functioning.

Interventions

This is an interpretation bias modification intervention that is designed to target hostile interpretation bias. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes.

BEHAVIORALMobile Intervention for Suicidal Thoughts (MIST)

This is an interpretation bias modification intervention that is designed to target cognitive factors that contribute to suicide risk. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will use the Mobile Intervention for Suicidal Thoughts (MIST) intervention for 4 weeks, followed by the Mobile Intervention for Reducing Anger (MIRA) for another 4 weeks.

Eligibility

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

Inclusion criteria

* Veterans 18 years or older * Diagnosed with PTSD, established via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) * Report a score of 12 on the 5-item Dimensions of Anger Reactions Scale * Can read at least 6th grade level material * Report a score of 1-3 (indicating ideation without intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS) * Have attended a mental health appointment within the past month, with another scheduled in the following month (i.e., be engaged in treatment with a mental health provider)

Exclusion criteria

* Diagnosed with bipolar or psychotic disorder. * Current substance use disorder. * Current imminent suicide risk or homicidal ideation requiring immediate intervention.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants RecruitedThrough study completion (approximately 10 months)Participant feasibility expectation will be met if recruitment is 75% (i.e., N = 8) or greater of recruitment expectation (N = 10).
Number of Enrolled Participants Who Complete the MIST InterventionPost-MIST assessment visit (approximately one month after enrollment)Treatment retention feasibility goal will be met if attrition from the MIST intervention is no more than 25% (i.e., not more than 3).
Number of Participants Reporting Satisfaction With MIST App: Client Satisfaction QuestionnairePost-MIST assessment 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 (i.e., at least 8 participants score a 3 or 4).
MIST App UtilizationPost-MIST assessment visit (approximately one month after enrollment)MIST app utilization goal will be met if MIST app utilization rates are greater than 50% of expected use (i.e., mean # of sessions completed is greater than 10).

Countries

United States

Participant flow

Participants by arm

ArmCount
MIST Intervention Followed by MIRA Intervention
These are both mobile interventions that use interpretation bias modification (IBM) techniques to reduce cognitive biases. The MIST app targets suicidal cognitions and the MIRA app targets hostile interpretation bias (which contributes to anger). The MIRA application has already been developed, but the MIST application is newly developed based on the same procedures. All participants will complete the MIST intervention and provide feedback so that we can refine it. We will also be collecting EMA data on to examine how changes to suicide cognitions and hostile interpretation bias (by use of the two apps) affects suicidal ideation and functioning. Mobile Intervention for Suicidal Thoughts (MIST): This is an interpretation bias modification intervention that is designed to target cognitive factors that contribute to suicide risk. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes. Mobile Intervention for Reducing Anger (MIRA): This is an interpretation bias modification intervention that is designed to target hostile interpretation bias. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes.
10
Total10

Baseline characteristics

CharacteristicMIST Intervention Followed by MIRA Intervention
Age, Continuous47.1 years
STANDARD_DEVIATION 12.25
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
10 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 104 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 10

Outcome results

Primary

MIST App Utilization

MIST app utilization goal will be met if MIST app utilization rates are greater than 50% of expected use (i.e., mean # of sessions completed is greater than 10).

Time frame: Post-MIST assessment visit (approximately one month after enrollment)

ArmMeasureValue (MEAN)Dispersion
MIST Intervention Followed by MIRA InterventionMIST App Utilization15.30 treatment sessions completedStandard Deviation 4.35
Primary

Number of Enrolled Participants Who Complete the MIST Intervention

Treatment retention feasibility goal will be met if attrition from the MIST intervention is no more than 25% (i.e., not more than 3).

Time frame: Post-MIST assessment visit (approximately one month after enrollment)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MIST Intervention Followed by MIRA InterventionNumber of Enrolled Participants Who Complete the MIST Intervention10 Participants
Primary

Number of Participants Recruited

Participant feasibility expectation will be met if recruitment is 75% (i.e., N = 8) or greater of recruitment expectation (N = 10).

Time frame: Through study completion (approximately 10 months)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MIST Intervention Followed by MIRA InterventionNumber of Participants Recruited10 Participants
Primary

Number of Participants Reporting Satisfaction With 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 (i.e., at least 8 participants score a 3 or 4).

Time frame: Post-MIST assessment visit (approximately one month after enrollment)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MIST Intervention Followed by MIRA InterventionNumber of Participants Reporting Satisfaction With MIST App: Client Satisfaction Questionnaire8 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026