Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

NCT04881903 | Completed Results

• 1 other identifier: CRX 21-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Suicide

Keywords

Suicide; Suicide cognitions; Anger; Mobile intervention

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

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.

Behavioral: Mobile Intervention for Suicidal Thoughts (MIST); Behavioral: Mobile Intervention for Reducing Anger (MIRA)

Interventions

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.

MIST intervention followed by MIRA intervention

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.

MIST intervention followed by MIRA intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Diagnosed with bipolar or psychotic disorder.
• Current substance use disorder.
• Current imminent suicide risk or homicidal ideation requiring immediate intervention.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Angela Kirby
• Organization: Durham VA Health Care System

angela.kirby@va.gov

919-824-7729

Study Officials

• Kirsten H Dillon, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: December 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)