Treatment for Non-Suicidal Self-Injury in Young Adults (T-SIB)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- NSSI frequency and severity [ Time Frame: Baseline, Mid-Treatment, Post-Treatment, 3-month Follow Up ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Margaret S Andover, Ph.D. | 718.817.0188 | moodbehavior@fordham.edu |
| United States, New York | |
| Fordham University | Recruiting |
| Bronx, New York, United States, 10458 | |
| 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 May 22, 2013