Trial Outcomes & Findings for Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (NCT NCT04881903)
NCT ID: NCT04881903
Last Updated: 2025-02-20
Results Overview
Participant feasibility expectation will be met if recruitment is 75% (i.e., N = 8) or greater of recruitment expectation (N = 10).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Through study completion (approximately 10 months)
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans
Baseline characteristics by cohort
| Measure |
MIST Intervention Followed by MIRA Intervention
n=10 Participants
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.
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|---|---|
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Age, Continuous
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47.1 years
STANDARD_DEVIATION 12.25 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Through 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).
Outcome measures
| Measure |
MIST Intervention Followed by MIRA Intervention
n=10 Participants
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.
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|---|---|
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Number of Participants Recruited
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10 Participants
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PRIMARY outcome
Timeframe: Post-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).
Outcome measures
| Measure |
MIST Intervention Followed by MIRA Intervention
n=10 Participants
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.
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|---|---|
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Number of Enrolled Participants Who Complete the MIST Intervention
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10 Participants
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PRIMARY outcome
Timeframe: Post-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).
Outcome measures
| Measure |
MIST Intervention Followed by MIRA Intervention
n=10 Participants
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.
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|---|---|
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Number of Participants Reporting Satisfaction With MIST App: Client Satisfaction Questionnaire
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8 Participants
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PRIMARY outcome
Timeframe: Post-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).
Outcome measures
| Measure |
MIST Intervention Followed by MIRA Intervention
n=10 Participants
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.
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|---|---|
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MIST App Utilization
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15.30 treatment sessions completed
Standard Deviation 4.35
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Adverse Events
MIST Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MIRA Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Screening
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MIST Intervention
n=10 participants at risk
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.
|
MIRA Intervention
n=10 participants at risk
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.
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Screening
n=10 participants at risk
This is the period between consent and beginning the intervention.
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|---|---|---|---|
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Psychiatric disorders
Distress during screen
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0.00%
0/10 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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0.00%
0/10 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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30.0%
3/10 • Number of events 3 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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Psychiatric disorders
Frustration with dealing with virtual visit platform
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0.00%
0/10 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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0.00%
0/10 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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10.0%
1/10 • Number of events 1 • 2.5 months
No adverse events occurred during the MIRA or MIST interventions; all adverse events occurred during the screen portion of the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place