Treatment for Non-Suicidal Self-Injury in Young Adults

Non-suicidal Self-injury Clinical Trial

— T-SIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018433
• Other study ID #: K23MH082824
• Secondary ID: K23MH082824DATR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 20, 2009
• Last updated: March 9, 2015
• Start date: September 2008
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Fordham University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-suicidal Self-injury

Intervention

Behavioral:
• T-SIB
Treatment for self-injurious behaviors; study psychotherapy

Other:
• Treatment as usual
Can include other psychotherapy and pharmacotherapy

Locations

Country	Name	City	State
United States	Fordham University	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Fordham University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NSSI frequency and severity		Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up	Yes
Secondary	BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA		Baseline, Post-Intervention, 3 month follow up	No