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Completed

NCT Number: NCT00401102

Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Interpersonal Psychotherapy for Depressed Adolescents

Behavioral

Open clinical trial of IPT-ASI for depressed and self-injuring adolescents, 12-18 years. Goal is to assess feasibility of using IPT-A protocol for teens with co-morbid depression and self-injury. All eligible participants receive 12 weeks of individual IPT-ASI with optional monthly booster sessions. IPT-ASI is a psychosocial intervention that focuses on the importance of interpersonal relationships in relation to psychological functioning. The first phase (4 weeks) includes a review of depression and self-injury symptoms, psycho-education about depression and self-injury, and a detailed assessment of the patient's important interpersonal relationships. The middle phase (weeks 5-9) involves interpersonal skill building, including communication skills, affect identification and expression, problem solving. The final phase ( weeks 10-12) involves review of skills, generalization of skills to other relationships, termination.

Primary outcomes

  1. CGI

    Time frame: 1 week

  2. C-GAS

    Time frame: 1 month

  3. CDRS

    Time frame: 1 week

  4. Self-Injurious Thoughts and Behaviors Interview

    Time frame: 8 weeks

  5. Self-injury Monitoring Card

    Time frame: 1 month

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 2 weeks

  2. Multidimensional Anxiety Scale for Children

    Time frame: recently

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • MINT: Mental Health Initiative

Registry information

Official study title

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

Acronym: IPT-ASI

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2006
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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