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Clinical Trials/NCT04881903
NCT04881903
Completed
Not Applicable

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

VA Office of Research and Development1 site in 1 country10 target enrollmentDecember 1, 2021
ConditionsSuicide

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide
Sponsor
VA Office of Research and Development
Enrollment
10
Locations
1
Primary Endpoint
Number of Participants Recruited
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
February 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Study Sites (1)

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