Treatment for Non-Suicidal Self-Injury in Young Adults (T-SIB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Fordham University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Fordham University
ClinicalTrials.gov Identifier:
NCT01018433
First received: November 20, 2009
Last updated: November 3, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Non-suicidal Self-injury
Behavioral: T-SIB
Other: Treatment as usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of an Intervention for Non-Suicidal Self-Injury in Young Adults

Resource links provided by NLM:


Further study details as provided by Fordham University:

Primary Outcome Measures:
  • NSSI frequency and severity [ Time Frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA [ Time Frame: Baseline, Post-Intervention, 3 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-SIB
Treatment for self-injurious behaviors; study intervention
Behavioral: T-SIB
Treatment for self-injurious behaviors; study psychotherapy
Other Name: T-SIB
Treatment as Usual Other: Treatment as usual
Can include other psychotherapy and pharmacotherapy
Other Name: TAU

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

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018433

Contacts
Contact: Margaret S Andover, Ph.D. 718.817.0188 moodbehavior@fordham.edu

Locations
United States, New York
Fordham University Recruiting
Bronx, New York, United States, 10458
Sponsors and Collaborators
Fordham University
Investigators
Principal Investigator: Margaret S Andover, Ph.D. Fordham University
  More Information

No publications provided

Responsible Party: Margaret Andover, Ph.D., Assistant Professor, Fordham University
ClinicalTrials.gov Identifier: NCT01018433     History of Changes
Other Study ID Numbers: K23 MH082824, K23MH082824, DATR AK-TNAI2
Study First Received: November 20, 2009
Last Updated: November 3, 2011
Health Authority: United States: Federal Government

Keywords provided by Fordham University:
self-injury
non-suicidal self-injury
deliberate self-harm
self-mutilation

ClinicalTrials.gov processed this record on September 16, 2014