NCT05969080

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Oct 2024Mar 2027

First Submitted

Initial submission to the registry

July 14, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

July 14, 2023

Last Update Submit

February 17, 2026

Conditions

Self-Injurious Behavior

Keywords

Self-Injurious BehaviorVeterans

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

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

    End of treatment, about nine weeks after beginning the study

Study Arms (2)

T-SIB

EXPERIMENTAL

Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.

Behavioral: Treatment for Self-Injurious Behaviors

Treatment As Usual

ACTIVE COMPARATOR

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: Treatment As Usual

Interventions

Treatment As UsualOTHER

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.

Also known as: TAU
Treatment As Usual
Treatment for Self-Injurious BehaviorsBEHAVIORAL

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

Also known as: T-SIB
T-SIB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Tate F Halverson, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tate F Halverson, PhD

CONTACT

(919) 286-0411Tate.Halverson@va.gov

Angela C Kirby, MS

CONTACT

(919) 286-0411angela.kirby@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 1, 2023

Study Start

October 15, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)