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Clinical Trials/NCT00401102
NCT00401102CompletedPhase 1

An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury

New York State Psychiatric Institute1 site in 1 country10 target enrollmentStarted: November 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
CGI

Study Overview

Brief Summary

The purpose of this study is to examine the feasibility of using Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) to treat adolescents who are experiencing symptoms of depression and are engaging in non-suicidal self-injurious behaviors. The trial will include recruiting 10 particpants, administering 12-sessions of individual IPT-A, and determining how the IPT-A protocol needs to be amended to adequately address the self-injury in addition to depression.

Detailed Description

Engagement in non-suicidal self-injury (NSSI), purposefully harming oneself without the conscious intent to die such as cutting or burning, is pervasive among adolescents. Lifetime prevalence estimates among community samples of high school students range from 13.0% to 23.2%. Despite the significance of this public health problem, there are no known interventions that successfully reduce the frequency of NSSI or prevent NSSI in adolescents. The goal of the current study is to develop an effective psychosocial intervention for NSSI among adolescents who are engaging in self-injury and have a depressive disorder. Specifically, we will amend Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), a psychotherapy that has demonstrated efficacy in treating depressed adolescents (Mufson et al., 1994, 1999, 2004), for use with adolescents with depression who are engaging in NSSI, with the ultimate goal of curing the depression and NSSI. Ten participants will be administered IPT-A and assessed several times throughout the course of the trial. It is expected that IPT-A will be a useful treatment for co-morbid depression and self-injury, although adaptations to the protocol will likely be needed to address the behavioral aspect of the self-injury. Data analyses will be descriptive in nature and involve examining the individual trajectories of depression and NSSI over time. The data obtained from the current study will lay the groundwork for an ultimate randomized controlled trial in which we plan to compare IPT-A versus nondirective supportive therapy in the treatment of co-morbid depression and NSSI.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •12 to 18 years of age
  • •Diagnosis of MDD, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder with depressed Mood
  • •Non-suicidal self-injurious behavior
  • •CDRS >= 36
  • •C-GAS <= 65
  • •English speaking patient
  • •One English speaking caregiver -

Exclusion Criteria

  • •Suicide attempt within past 6 months or actively suicidal
  • •Severe incident of non-suicidal self-injury in past 3 months
  • •Severe episode of MDD
  • •Treatment resistant non-suicidal self-injury
  • •Frequent non-suicidal self-injury
  • •Mentally retarded
  • •Current diagnosis of: PTSD, OCD, Schizophrenia, Bipolar Disorder, Psychosis, Substance Dependence, ADHD
  • •Current substance use
  • •Currently in active treatment for same condition
  • •Currently taking antidepressant medication
  • •Medical illness likely to interfere with treatment -

Arms & Interventions

Interpersonal psychotherapy

Other

All participants received interpersonal psychotherapy adapted for self-injury

Intervention: Interpersonal Psychotherapy for Depressed Adolescents (Behavioral)

Outcomes

Primary Outcomes

CGI

Time Frame: 1 week

C-GAS

Time Frame: 1 month

CDRS

Time Frame: 1 week

Self-Injurious Thoughts and Behaviors Interview

Time Frame: 8 weeks

Self-injury Monitoring Card

Time Frame: 1 month

Secondary Outcomes

  • Beck Depression Inventory(2 weeks)
  • Multidimensional Anxiety Scale for Children(recently)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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