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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIST intervention followed by MIRA intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Intervention for Suicidal Thoughts (MIST) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion (approximately 10 months) |
| 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). | Post-MIST assessment visit (approximately one month after enrollment) |
| 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). | Post-MIST assessment visit (approximately one month after enrollment) |
| 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). | Post-MIST assessment visit (approximately one month after enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten H Dillon, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | Through study completion (approximately 10 months) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MIST Intervention | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distress during screen | Psychiatric disorders | Non-systematic Assessment | Temporary distress related to completing self-report measures about trauma and/or structured interviews about trauma and posttraumatic stress disorder symptoms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | Durham VA Health Care System | 919-824-7729 | angela.kirby@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2023 | Jan 15, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2023 | Jan 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| Mobile Intervention for Reducing Anger (MIRA) | Behavioral | 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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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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). | Posted | Count of Participants | Participants | Post-MIST assessment visit (approximately one month after enrollment) |
|
|
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| 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). | Posted | Count of Participants | Participants | Post-MIST assessment visit (approximately one month after enrollment) |
|
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| 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). | Posted | Mean | Standard Deviation | treatment sessions completed | Post-MIST assessment visit (approximately one month after enrollment) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | MIRA Intervention | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Screening | This is the period between consent and beginning the intervention. | 0 | 10 | 0 | 10 | 4 | 10 |
|
| Frustration with dealing with virtual visit platform | Psychiatric disorders | Non-systematic Assessment |
|
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