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

Primary Purpose

Non-suicidal Self-injury

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

T-SIB

Treatment as usual

About this trial

This is an interventional treatment trial for Non-suicidal Self-injury focused on measuring self-injury, non-suicidal self-injury, deliberate self-harm, self-mutilation

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Fordham University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

T-SIB

Treatment as Usual

Arm Description

Treatment for self-injurious behaviors; study intervention

Outcomes

Primary Outcome Measures

NSSI frequency and severity

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01018433

First Posted

November 20, 2009

Last Updated

March 9, 2015

Sponsor

Fordham University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01018433

Brief Title

Treatment for Non-Suicidal Self-Injury in Young Adults

Acronym

T-SIB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fordham University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-suicidal Self-injury

Keywords

self-injury, non-suicidal self-injury, deliberate self-harm, self-mutilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T-SIB

Arm Type

Experimental

Arm Description

Treatment for self-injurious behaviors; study intervention

Arm Title

Treatment as Usual

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

T-SIB

Intervention Description

Treatment for self-injurious behaviors; study psychotherapy

Intervention Type

Other

Intervention Name(s)

Treatment as usual

Other Intervention Name(s)

TAU

Intervention Description

Can include other psychotherapy and pharmacotherapy

Primary Outcome Measure Information:

Title

NSSI frequency and severity

Time Frame

Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline, Post-Intervention, 3 month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret S Andover, Ph.D.

Organizational Affiliation

Fordham University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fordham University

City

Bronx

State/Province

New York

ZIP/Postal Code

10458

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Treatment for Non-Suicidal Self-Injury in Young Adults

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