Clinical trial NCT01018433: Treatment for Non-Suicidal Self-Injury in Young Adults
Official title: Development of an Intervention for Non-Suicidal Self-Injury in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-suicidal Self-injury
Keywords: self-injury
non-suicidal self-injury
deliberate self-harm
self-mutilation
Lead sponsor: Fordham University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-11-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NSSI frequency and severity
timeFrame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up
Secondary outcomes:
measure: BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA
timeFrame: Baseline, Post-Intervention, 3 month follow up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Fordham University
state: New York
Study officials:
affiliation: Fordham University
name: Margaret S Andover, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: