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

Primary Purpose

Depression, Self-injurious Behavior

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Depressed Adolescents
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring self-injurious behavior, depression, adolescents, psychotherapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interpersonal psychotherapy

Arm Description

All participants received interpersonal psychotherapy adapted for self-injury

Outcomes

Primary Outcome Measures

CGI
C-GAS
CDRS
Self-Injurious Thoughts and Behaviors Interview
Self-injury Monitoring Card

Secondary Outcome Measures

Beck Depression Inventory
Multidimensional Anxiety Scale for Children

Full Information

First Posted
November 15, 2006
Last Updated
December 20, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
MINT: Mental Health Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT00401102
Brief Title
Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury
Acronym
IPT-ASI
Official Title
An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
MINT: Mental Health Initiative

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Self-injurious Behavior
Keywords
self-injurious behavior, depression, adolescents, psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal psychotherapy
Arm Type
Other
Arm Description
All participants received interpersonal psychotherapy adapted for self-injury
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Depressed Adolescents
Intervention Description
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 Outcome Measure Information:
Title
CGI
Time Frame
1 week
Title
C-GAS
Time Frame
1 month
Title
CDRS
Time Frame
1 week
Title
Self-Injurious Thoughts and Behaviors Interview
Time Frame
8 weeks
Title
Self-injury Monitoring Card
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
2 weeks
Title
Multidimensional Anxiety Scale for Children
Time Frame
recently

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Jacobson, PhD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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