Treatment for Non-Suicidal Self-Injury in Young Adults

NCT ID: NCT01018433

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-07-31

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.

Conditions

Non-suicidal Self-injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

T-SIB

Treatment for self-injurious behaviors; study intervention

Group Type: EXPERIMENTAL

T-SIB

Intervention Type: BEHAVIORAL

Treatment for self-injurious behaviors; study psychotherapy

Treatment as Usual

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

Can include other psychotherapy and pharmacotherapy

Interventions

T-SIB

Treatment for self-injurious behaviors; study psychotherapy

Intervention Type: BEHAVIORAL

Treatment as usual

Can include other psychotherapy and pharmacotherapy

Intervention Type: OTHER

Other Intervention Names

TAU

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Fordham University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret S Andover, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fordham University

Locations

Fordham University

The Bronx, New York, United States

Countries

United States

Other Identifiers

K23MH082824

Identifier Type: NIH

Identifier Source: secondary_id

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DATR AK-TNAI2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

K23MH082824

Identifier Type: NIH

Identifier Source: org_study_id

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