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NCT Number: NCT05969080

Self-Injury Treatment and Recovery in Veterans

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location status: Recruiting

Location contact

Angela C Kirby, MS

CONTACT

[email protected]

(919) 286-0411 ext. 7456

Tate F Halverson, PhD

CONTACT

[email protected]

919-286-0411 ext. 175415

Tate F Halverson, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment for Self-Injurious Behaviors

Behavioral

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

Other names: T-SIB

Treatment as Usual

Other

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.

Other names: TAU

Primary outcomes

  1. Feasibility as measured by number of participants enrolled

    Time frame: 2 years after study enrollment begins

    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. Feasibility as measured rate of retention

    Time frame: End of treatment, about nine weeks after beginning the study

    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.

Secondary outcomes

  1. Number of participants who report satisfaction with the T-SIB treatment

    Time frame: End of treatment, about nine weeks after beginning the study

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela C Kirby, MS

CONTACT

[email protected]

(919) 286-0411 ext. 7456

Tate F Halverson, PhD

CONTACT

[email protected]

(919) 286-0411 ext. 175415

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: STRIVe

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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