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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Self-injurious Behavior
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy for Depressed Adolescents

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CGI	1 week
C-GAS	1 month
CDRS	1 week
Self-Injurious Thoughts and Behaviors Interview	8 weeks
Self-injury Monitoring Card	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory	2 weeks
Multidimensional Anxiety Scale for Children	recently

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: MINT: Mental Health Initiative
• Investigators: Principal Investigator: Colleen Jacobson, PhD, NYSPI

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: November 15, 2006
• First Submitted That Met QC Criteria: November 15, 2006
• First Posted (ESTIMATE): November 17, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: depression; adolescents; psychotherapy; self-injurious behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Self-Injurious Behavior
• Other Study ID Numbers: 5332