Self-Injury Treatment and Recovery in Veterans

Self-Injurious Behavior Clinical Trial

— STRIVe  

Official title:

A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969080
• Other study ID #: D4803-W
• Secondary ID: 1745432
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2025
• Est. completion date: March 31, 2027

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: Tate F Halverson, PhD
• Phone: (919) 286-0411
• Email: Tate.Halverson[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.

Description:

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB is functional assessment that identifies the antecedents and consequences of NSSI. This project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI functional assessment in-vivo. EMA reduces retrospective recall bias and can increase engagement with therapeutic goals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• Past service in the United States military
• Nonsuicidal self-injury engagement on 2 occasions in past 30 days
• Fluent in English
• Able to provide voluntary informed consent

Exclusion Criteria:

• Lifetime history of psychosis, mania, or hypomania
• Imminent risk for suicide/homicide warranting immediate intervention
• Unable/unwilling to complete study procedures

Related Conditions & MeSH terms

• Self-Injurious Behavior

Intervention

Behavioral:
• Treatment for Self-Injurious Behaviors
Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.

Other:
• Treatment As Usual
Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.

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	Feasibility as measured by number of participants enrolled	All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.	2 years after study enrollment begins
Primary	Feasibility as measured rate of retention	Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2/3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.	End of treatment, about nine weeks after beginning the study
Secondary	Number of participants who report satisfaction with the T-SIB treatment	Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, which higher scores indicating higher satisfaction. A cut score of 24 will be used such that if the CSQ-8 score exceeds 24, that patient is deemed to have been satisfied with the treatment.	End of treatment, about nine weeks after beginning the study