SuicideNCT04881903
Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans
A study testing Mobile Intervention for Suicidal Thoughts (MIST) and Mobile Intervention for Reducing Anger (MIRA) in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Mobile Intervention for Suicidal Thoughts (MIST) and Mobile Intervention for Reducing Anger (MIRA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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)
Who cannot join
- Diagnosed with bipolar or psychotic disorder.
- Current substance use disorder.
- Current imminent suicide risk or homicidal ideation requiring immediate intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (COR 19-490)
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Mobile Intervention for Suicidal Thoughts (MIST), Mobile Intervention for Reducing Anger (MIRA)
- Keywords
- Suicide, Suicide cognitions, Anger, Mobile intervention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Intervention for Suicidal Thoughts (MIST)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Intervention for Suicidal Thoughts (MIST); Behavioral: Mobile Intervention for Reducing Anger (MIRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
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 posted11 May 2021
- Study start1 Dec 2021
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- NCT04881903
- Sponsor's protocol ID
- CRX 21-001
- Status last verified
- Feb 2025
- First submitted
- 5 May 2021
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (COR 19-490)
- ClinicalTrials.gov ID
- NCT04881903
- Acronym / sponsor ID
- CRX 21-001
- Conditions
- Suicide
- Keywords
- Suicide, Suicide cognitions, Anger, Mobile intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 20 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| MIST intervention followed by MIRA intervention | Experimental | Behavioral: Mobile Intervention for Suicidal Thoughts (MIST), Behavioral: Mobile Intervention for Reducing Anger (MIRA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Diagnosed with bipolar or psychotic disorder.
- Current substance use disorder.
- Current imminent suicide risk or homicidal ideation requiring immediate intervention.
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 |
|---|---|---|
| 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. | Behavioural | MIST intervention followed by 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. | Behavioural | MIST intervention followed by MIRA intervention |
Primary outcome
Number of Participants Recruited
Time frame: 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).
Number of Enrolled Participants Who Complete the MIST Intervention
Time frame: 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).
Number of Participants Reporting Satisfaction With MIST App: Client Satisfaction Questionnaire
Time frame: 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).
MIST App Utilization
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 Mobile Intervention for Suicidal Thoughts (MIST) and Mobile Intervention for Reducing Anger (MIRA) 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited (time frame: Through study completion (approximately 10 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 20 Feb 2025.