NCT01018433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5.8 years

First QC Date

November 20, 2009

Last Update Submit

March 9, 2015

Conditions

Non-suicidal Self-injury

Keywords

self-injurynon-suicidal self-injurydeliberate self-harmself-mutilation

Outcome Measures

Primary Outcomes (1)

  • NSSI frequency and severity

    Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up

Secondary Outcomes (1)

  • BDI-II BAI MSI-BPD CSI SPSI-R SCL-90-R URICA

    Baseline, Post-Intervention, 3 month follow up

Study Arms (2)

T-SIB

EXPERIMENTAL

Treatment for self-injurious behaviors; study intervention

Behavioral: T-SIB

Treatment as Usual

OTHER
Other: Treatment as usual

Interventions

T-SIBBEHAVIORAL

Treatment for self-injurious behaviors; study psychotherapy

T-SIB
Treatment as usualOTHER

Can include other psychotherapy and pharmacotherapy

Also known as: TAU
Treatment as Usual

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-29
  • NSSI within the past month OR history of NSSI and urge to self-injure within the past month

You may not qualify if:

  • Psychotic symptoms
  • Severe suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fordham University

The Bronx, New York, 10458, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Margaret S Andover, Ph.D.

    Fordham University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

US(1)