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OpenTrials
Completed

NCT Number: NCT04881903

Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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).

  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).

  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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 11, 2021
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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