Treatment for Non-Suicidal Self-Injury in Young Adults (T-SIB)

March 9, 2015 updated by: Fordham University

Development of an Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10458
        • Fordham University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T-SIB
Treatment for self-injurious behaviors; study intervention
Behavioral: T-SIB
Treatment for self-injurious behaviors; study psychotherapy
OTHER: Treatment as Usual
Other: Treatment as usual
Can include other psychotherapy and pharmacotherapy
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NSSI frequency and severity
Time Frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up
Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

Secondary Outcome Measures

Outcome Measure
Time Frame
BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA
Time Frame: Baseline, Post-Intervention, 3 month follow up
Baseline, Post-Intervention, 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fordham University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Margaret S Andover, Ph.D., Fordham University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (ESTIMATE)

November 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH082824 (NIH)
  • DATR AK-TNAI2 (National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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