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Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Intervention for Suicidal Thoughts (MIST)
Mobile Intervention for Reducing Anger (MIRA)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Suicide cognitions, Anger, Mobile intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VA Medical Center, Durham, NCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIST intervention followed by MIRA intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants recruited
Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Percentage 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%.
Patient satisfaction or 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.
MIST App utilization
MIST app utilization goal will be met if MIST app utilization rates are greater than 50% of expected use.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2021
Last Updated
July 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04881903
Brief Title
Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans
Official Title
Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans (COR 19-490)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide, Suicide cognitions, Anger, Mobile intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIST intervention followed by MIRA intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Intervention for Suicidal Thoughts (MIST)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Intervention for Reducing Anger (MIRA)
Intervention Description
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 Outcome Measure Information:
Title
Number of participants recruited
Description
Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Time Frame
Through study completion (approximately 10 months)
Title
Percentage of enrolled participants who complete the MIST intervention
Description
Treatment retention feasibility goal will be met if attrition from the MIST intervention is no more than 25%.
Time Frame
Post-MIST assessment visit (approximately one month after enrollment)
Title
Patient satisfaction or MIST app: Client Satisfaction Questionnaire
Description
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.
Time Frame
Post-MIST assessment visit (approximately one month after enrollment)
Title
MIST App utilization
Description
MIST app utilization goal will be met if MIST app utilization rates are greater than 50% of expected use.
Time Frame
Post-MIST assessment visit (approximately one month after enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten H Dillon, PhD
Phone
(919) 286-0411
Email
Kirsten.Dillon@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD
Phone
919-286-0411
Email
Kirsten.Dillon@va.gov
First Name & Middle Initial & Last Name & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
First Name & Middle Initial & Last Name & Degree
Kirsten H Dillon, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

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