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Clinical Trials/NCT01018433
NCT01018433
Completed
Phase 1

Development of an Intervention for Non-Suicidal Self-Injury in Young Adults

Fordham University1 site in 1 country45 target enrollmentSeptember 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Non-suicidal Self-injury
Sponsor
Fordham University
Enrollment
45
Locations
1
Primary Endpoint
NSSI frequency and severity
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

NSSI frequency and severity

Time Frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

Secondary Outcomes

  • BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA(Baseline, Post-Intervention, 3 month follow up)

Study Sites (1)

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