A Phase 1/2 interventional study of T-SIB and Treatment as usual in Non-suicidal Self-injury, sponsored by Fordham University. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by Fordham University · Phase 1/2, Interventional, and Treatment
The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled pilot study in order to determine the feasibility and acceptability of the intervention and to investigate change in NSSI frequency and severity over time.
Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in medical severity, distress from shame associated with the behavior, social isolation, psychological symptoms, and increased risk and lethality of NSSI over time. Despite the prevalence and significant consequences of NSSI, no empirically supported treatments specific to NSSI exist. The purpose of this study is to develop, implement, and evaluate an intervention specifically for NSSI in young adults, the Treatment for Self-Injurious Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based strategies whose utility has been identified through empirical research with the goal of reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase 1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be treated in a randomized controlled pilot study to determine the feasibility and acceptability of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as usual (TAU) through a 3-month follow up period, and evaluate the research design of the randomized controlled pilot study to inform both the utility and design of a larger randomized clinical trial.
259 studies on the registry are indexed under Self-Injurious Behavior; 95 are open to participants now.
This study's enrollment of 45 is below the median of 66 across 219 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Fordham University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Treatment for self-injurious behaviors; study intervention
Behavioral: T-SIB
Other: Treatment as usual
Treatment for self-injurious behaviors; study psychotherapy
Can include other psychotherapy and pharmacotherapy
Also known as: TAU
NSSI frequency and severity
Time frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up
BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA
Time frame: Baseline, Post-Intervention, 3 month follow up
The record gives a start of Sep 2008, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Fordham University