Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Mobile Intervention for Suicidal Thoughts (MIST); Behavioral: Mobile Intervention for Reducing Anger (MIRA)

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kirsten H Dillon, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Suicide; Anger; Mobile intervention; Suicide cognitions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: CRX 21-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No