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Completed

NCT Number: NCT01018433

Treatment for Non-Suicidal Self-Injury in Young Adults

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fordham University

The Bronx, New York, 10458, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-SIB

Behavioral

Treatment for self-injurious behaviors; study psychotherapy

Treatment as Usual

Other

Can include other psychotherapy and pharmacotherapy

Other names: TAU

Primary outcomes

  1. NSSI frequency and severity

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

Secondary outcomes

  1. BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA

    Time frame: Baseline, Post-Intervention, 3 month follow up

Sponsors and collaborators

Lead sponsor

Fordham University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: T-SIB

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 23, 2009
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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