Self-Injury Treatment and Recovery in Veterans
ConditionSelf-Injurious Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lifetime history of psychosis, mania, or hypomania
Imminent risk for suicide/homicide warranting immediate intervention
Unable/unwilling to complete study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Treatment for Self-Injurious Behaviors
BehavioralTreatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.
Treatment As Usual
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: T-SIBExperimental treatment 1 intervention
Group B: Treatment As UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years after study enrollment begins2
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.
Time frame
End of treatment, about nine weeks after beginning the studySecondary outcomes
1
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.
Time frame
End of treatment, about nine weeks after beginning the studySponsors and contacts
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Source ClinicalTrials.gov