Treatment for Non-Suicidal Self-Injury in Young Adults

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018433

Acronym

T-SIB

Enrollment

Registered

2009-11-23

Start date

2008-09-30

Completion date

2014-07-31

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-suicidal Self-injury

Keywords

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

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.

Interventions

BEHAVIORALT-SIB

Treatment for self-injurious behaviors; study psychotherapy

OTHERTreatment as usual

Can include other psychotherapy and pharmacotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 29 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026