Treatment for Non-Suicidal Self-Injury in Young Adults

Phase 1

Completed

• Conditions: Non-suicidal Self-injury
• Interventions: Behavioral: T-SIB; Other: Treatment as usual

• Registration Number: NCT01018433
• Lead Sponsor: Fordham University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Ages 18-29
• NSSI within the past month OR history of NSSI and urge to self-injure within the past month

Exclusion Criteria

• Psychotic symptoms
• Severe suicidal ideation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-SIB	T-SIB	Treatment for self-injurious behaviors; study intervention
Treatment as Usual	Treatment as usual	-

Primary Outcome Measures

Name	Time	Method
NSSI frequency and severity	Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

Secondary Outcome Measures

Name	Time	Method
BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA	Baseline, Post-Intervention, 3 month follow up

Trial Locations

Locations (1)

Fordham University; 🇺🇸 Bronx, New York, United States