Treatment for Non-Suicidal Self-Injury in Young Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-suicidal Self-injury

Intervention / Treatment
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* Behavioral: T-SIB
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-SIB<br>Treatment for self-injurious behaviors; study intervention | Behavioral: T-SIB<br>* Treatment for self-injurious behaviors; study psychotherapy<br>|
| Other: Treatment as Usual<br> | Other: Treatment as usual<br>* Can include other psychotherapy and pharmacotherapy<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-injury, non-suicidal self-injury, deliberate self-harm, self-mutilation