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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
Self-injurious Behavior
 Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury

Resource links provided by NLM:

MedlinePlus related topics: Depression Self-harm
U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: November 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Interpersonal psychotherapy
All participants received interpersonal psychotherapy adapted for self-injury
 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401102

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
MINT: Mental Health Initiative
Investigators
Principal Investigator: Colleen Jacobson, PhD NYSPI
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00401102     History of Changes
Other Study ID Numbers: 5332
Study First Received: November 15, 2006
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
self-injurious behavior
depression
adolescents
psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Self-Injurious Behavior
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013