Developing a Mobile Intervention to Reduce Suicidal Cognitions in Veterans

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881903
• Other study ID #: CRX 21-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited	Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.	Through study completion (approximately 10 months)
Primary	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%.	Post-MIST assessment visit (approximately one month after enrollment)
Primary	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.	Post-MIST assessment visit (approximately one month after enrollment)
Primary	MIST App utilization	MIST app utilization goal will be met if MIST app utilization rates are greater than 50% of expected use.	Post-MIST assessment visit (approximately one month after enrollment)