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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401102
• Other study ID #: 5332
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: December 20, 2012
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Self-injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	MINT: Mental Health Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI		1 week	Yes
Primary	C-GAS		1 month	No
Primary	CDRS		1 week	Yes
Primary	Self-Injurious Thoughts and Behaviors Interview		8 weeks	No
Primary	Self-injury Monitoring Card		1 month	No
Secondary	Beck Depression Inventory		2 weeks	No
Secondary	Multidimensional Anxiety Scale for Children		recently	No