Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury (IPT-ASI)

This study has been completed.
Sponsor:
Collaborator:
MINT: Mental Health Initiative
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00401102
First received: November 15, 2006
Last updated: December 20, 2012
Last verified: December 2012

November 15, 2006
December 20, 2012
November 2006
September 2009   (final data collection date for primary outcome measure)
  • CGI [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • C-GAS [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • CDRS [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Self-Injurious Thoughts and Behaviors Interview [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Self-injury Monitoring Card [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • CGI
  • C-GAS
  • CDRS
  • Self-Injurious Thoughts and Behaviors Interview
  • Self-injury Monitoring Card
Complete list of historical versions of study NCT00401102 on ClinicalTrials.gov Archive Site
  • Beck Depression Inventory [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Multidimensional Anxiety Scale for Children [ Time Frame: recently ] [ Designated as safety issue: No ]
  • Beck Depression Inventory
  • Multidimensional Anxiety Scale for Children
Not Provided
Not Provided
 
Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury
An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged 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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Self-injurious Behavior
Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
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.
Interpersonal psychotherapy
All participants received interpersonal psychotherapy adapted for self-injury
Intervention: Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 12 to 18 years of age
  2. Diagnosis of MDD, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder with depressed Mood
  3. Non-suicidal self-injurious behavior
  4. CDRS >= 36
  5. C-GAS <= 65
  6. English speaking patient
  7. One English speaking caregiver -

Exclusion Criteria:

  1. Suicide attempt within past 6 months or actively suicidal
  2. Severe incident of non-suicidal self-injury in past 3 months
  3. Severe episode of MDD
  4. Treatment resistant non-suicidal self-injury
  5. Frequent non-suicidal self-injury
  6. Mentally retarded
  7. Current diagnosis of: PTSD, OCD, Schizophrenia, Bipolar Disorder, Psychosis, Substance Dependence, ADHD
  8. Current substance use
  9. Currently in active treatment for same condition
  10. Currently taking antidepressant medication
  11. Medical illness likely to interfere with treatment -
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00401102
5332
No
New York State Psychiatric Institute
New York State Psychiatric Institute
MINT: Mental Health Initiative
Principal Investigator: Colleen Jacobson, PhD NYSPI
New York State Psychiatric Institute
December 2012

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