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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

November 20, 2009
November 3, 2011
September 2008
July 2013   (final data collection date for primary outcome measure)
NSSI frequency and severity [ Time Frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01018433 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Treatment for Non-Suicidal Self-Injury in Young Adults
Development of an Intervention for Non-Suicidal Self-Injury in Young Adults

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Non-suicidal Self-injury
  • Behavioral: T-SIB
    Treatment for self-injurious behaviors; study psychotherapy
    Other Name: T-SIB
  • Other: Treatment as usual
    Can include other psychotherapy and pharmacotherapy
    Other Name: TAU
  • Experimental: T-SIB
    Treatment for self-injurious behaviors; study intervention
    Intervention: Behavioral: T-SIB
  • Treatment as Usual
    Intervention: Other: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 29 Years
Yes
Contact: Margaret S Andover, Ph.D. 718.817.0188 moodbehavior@fordham.edu
United States
 
NCT01018433
K23 MH082824, K23MH082824, DATR AK-TNAI2
Yes
Margaret Andover, Ph.D., Assistant Professor, Fordham University
Fordham University
National Institute of Mental Health (NIMH)
Principal Investigator: Margaret S Andover, Ph.D. Fordham University
Fordham University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP